Register a trial

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05182840




Registration number
NCT05182840
Ethics application status
Date submitted
5/01/2022
Date registered
10/01/2022

Titles & IDs
Public title
A Study to Test Whether Different Doses of BI 690517 Alone or in Combination With Empagliflozin Improve Kidney Function in People With Chronic Kidney Disease
Scientific title
Randomised, Double-blind, Placebo-controlled and Parallel Dose Group Trial to Investigate Efficacy and Safety of Multiple Doses of Oral BI 690517 Over 14 Weeks, Alone and in Combination With Empagliflozin, in Patients With Diabetic and Non-diabetic Chronic Kidney Disease
Secondary ID [1] 0 0
2021-001434-19
Secondary ID [2] 0 0
1378.5
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Kidney Disease, Chronic 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BI 690517
Treatment: Drugs - Placebo to BI 690517
Treatment: Drugs - Empagliflozin
Treatment: Drugs - Placebo to empagliflozin

Experimental: Run-in period: 10 mg empagliflozin -

Placebo comparator: Run-in period: Placebo to empagliflozin 10 mg -

Experimental: Treatment period: 10 mg empagliflozin + 3 mg BI 690517 -

Experimental: Treatment period: 10 mg empagliflozin + 10 mg BI 690517 -

Experimental: Treatment period: 10 mg empagliflozin + 20 mg BI 690517 -

Placebo comparator: Treatment period: 10 mg empagliflozin + Placebo to BI 690517 -

Experimental: Treatment period: Placebo to empagliflozin 10 mg + 3 mg BI 690517 -

Experimental: Treatment period: Placebo to empagliflozin 10 mg + 10 mg BI 690517 -

Experimental: Treatment period: Placebo to empagliflozin 10 mg + 20 mg BI 690517 -

Placebo comparator: Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517 -


Treatment: Drugs: BI 690517
Film-coated tablets

Treatment: Drugs: Placebo to BI 690517
Film-coated tablets

Treatment: Drugs: Empagliflozin
Empagliflozin

Treatment: Drugs: Placebo to empagliflozin
Placebo to empagliflozin
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Treatment Period Baseline in Log Transformed Urine Albumin Creatinine Ratio (UACR) Measured in First Morning Void (FMV) Urine After 14 Weeks - All Patients
Timepoint [1] 0 0
The MMRM model is a longitudinal analysis and it incorporated UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period.
Primary outcome [2] 0 0
Percent Change of FMV UACR From Baseline to Week 14 Based on Adjusted Median (95% CI) Back Transformed From MMRM Estimate - All Patients
Timepoint [2] 0 0
The MMRM model is a longitudinal analysis and it incorporated UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period.
Primary outcome [3] 0 0
Change From Baseline to Week 14 in the Log Transformed FMV UACR - Patients With Background Therapy of Placebo Matching Empagliflozin
Timepoint [3] 0 0
The MMRM model is a longitudinal analysis and it incorporated UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period.
Primary outcome [4] 0 0
Percent Change of FMV UACR From Baseline to Week 14 Based on Adjusted Median (95% CI) Back Transformed From MMRM Estimate - Patients With Background Therapy of Placebo Matching Empagliflozin
Timepoint [4] 0 0
The MMRM model is a longitudinal analysis and it incorporated UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period.
Primary outcome [5] 0 0
Change From Baseline to Week 14 in the Log Transformed FMV UACR - Patients With Background Therapy of Empagliflozin
Timepoint [5] 0 0
The MMRM model is a longitudinal analysis and it incorporated UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period.
Primary outcome [6] 0 0
Percent Change of FMV UACR From Baseline to Week 14 Based on Adjusted Median (95% CI) of MMRM Estimate - Patients With Background Therapy of Empagliflozin
Timepoint [6] 0 0
The MMRM model is a longitudinal analysis and it incorporated UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period.
Secondary outcome [1] 0 0
UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - All Patients - Multiple Imputation
Timepoint [1] 0 0
UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period were used for the multiple imputation approach.
Secondary outcome [2] 0 0
UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - All Patients - Missing as Non-Responder
Timepoint [2] 0 0
At baseline (Week 6,7 or 8 of the Run-in period) and at Week 12-14 of the Treatment Period.
Secondary outcome [3] 0 0
UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Week - All Patients - Last Observation on Treatment Carried Forward (LOCF)
Timepoint [3] 0 0
UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period were used for the last observation carried forward approach.
Secondary outcome [4] 0 0
UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - All Patients - Complete Case Analysis
Timepoint [4] 0 0
At baseline (Week 6,7 or 8 of the Run-in period) and at Week 12-14 of the Treatment Period.
Secondary outcome [5] 0 0
UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Placebo Matching Empagliflozin - Multiple Imputation
Timepoint [5] 0 0
UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period were used for the multiple imputation approach.
Secondary outcome [6] 0 0
UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Placebo Matching Empagliflozin - Missing as Non-Responder
Timepoint [6] 0 0
At baseline (Week 6,7 or 8 of the Run-in period) and at Week 12-14 of the Treatment Period.
Secondary outcome [7] 0 0
UACR Response I, Defined as Decrease of at Least 30% Absolute Change in FMV Urine of UACR From Treatment Period Baseline to 14 Weeks - Background Therapy of Placebo Matching Empagliflozin - Last Observation on Treatment Carried Forward (LOCF)
Timepoint [7] 0 0
UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period were used for the last observation carried forward approach.
Secondary outcome [8] 0 0
UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Placebo Matching Empagliflozin - Complete Case Analysis
Timepoint [8] 0 0
At baseline (Week 6,7 or 8 of the Run-in period) and at Week 12-14 of the Treatment Period.
Secondary outcome [9] 0 0
UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Empagliflozin - Multiple Imputation
Timepoint [9] 0 0
UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period were used for the multiple imputation approach.
Secondary outcome [10] 0 0
UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Empagliflozin - Missing as Non-Responder
Timepoint [10] 0 0
At baseline (Week 6,7 or 8 of the Run-in period) and at Week 12-14 of the Treatment Period.
Secondary outcome [11] 0 0
UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Empagliflozin - Last Observation on Treatment Carried Forward
Timepoint [11] 0 0
UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period were used for the last observation carried forward approach.
Secondary outcome [12] 0 0
UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Empagliflozin - Complete Case Analysis
Timepoint [12] 0 0
At baseline (Week 6,7 or 8 of the Run-in period) and at Week 12-14 of the Treatment Period.
Secondary outcome [13] 0 0
UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - All Patients -Multiple Imputation
Timepoint [13] 0 0
UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period were used for the multiple imputation approach.
Secondary outcome [14] 0 0
UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - All Patients - Missing as Non-Responder
Timepoint [14] 0 0
At baseline (Week 6,7 or 8 of the Run-in period) and at Week 12-14 of the Treatment Period.
Secondary outcome [15] 0 0
UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - All Patients - Last Observation on Treatment Carried Forward (LOCF)
Timepoint [15] 0 0
UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period were used for the last observation carried forward approach.
Secondary outcome [16] 0 0
UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - All Patients - Complete Case Analysis
Timepoint [16] 0 0
At baseline (Week 6,7 or 8 of the Run-in period) and at Week 12-14 of the Treatment Period.
Secondary outcome [17] 0 0
UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Placebo Matching Empagliflozin - Multiple Imputation
Timepoint [17] 0 0
UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period were used for the multiple imputation approach.
Secondary outcome [18] 0 0
UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Placebo Matching Empagliflozin - Missing as Non-Responder
Timepoint [18] 0 0
At baseline (Week 6,7 or 8 of the Run-in period) and at Week 12-14 of the Treatment Period.
Secondary outcome [19] 0 0
UACR Response II, Defined as Decrease of at Least 15% Absolute Change in FMV Urine of UACR From Treatment Period Baseline to 14 Weeks - Background Therapy of Placebo Matching Empagliflozin - Last Observation on Treatment Carried Forward (LOCF)
Timepoint [19] 0 0
UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period were used for the last observation carried forward approach.
Secondary outcome [20] 0 0
UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Empagliflozin - Multiple Imputation
Timepoint [20] 0 0
UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period were used for the multiple imputation approach.
Secondary outcome [21] 0 0
UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Empagliflozin - Missing as Non-Responder
Timepoint [21] 0 0
At baseline (Week 6,7 or 8 of the Run-in period) and at Week 12-14 of the Treatment Period.
Secondary outcome [22] 0 0
UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Empagliflozin - Last Observation on Treatment Carried Forward
Timepoint [22] 0 0
UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period were used for the last observation carried forward approach.
Secondary outcome [23] 0 0
UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks -Patients With Background Therapy of Placebo Matching Empagliflozin - Complete Case Analysis
Timepoint [23] 0 0
At baseline (Week 6,7 or 8 of the Run-in period) and at Week 12-14 of the Treatment Period.
Secondary outcome [24] 0 0
UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Empagliflozin - Complete Case Analysis
Timepoint [24] 0 0
At baseline (Week 6,7 or 8 of the Run-in period) and at Week 12-14 of the Treatment Period.

Eligibility
Key inclusion criteria
Inclusion criteria

* Signed and dated written informed consent in accordance with International Council on Harmonisation - Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial.
* Male or female patients of legal adult age (according to local legislation) and aged = 18 years at time of consent.
* estimated Glomerular Filtration Rate (eGFR, Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] formula) = 30 and < 90 mL/min/1.73 m2 at Visit 1 by central laboratory analysis.
* Urine Albumin Creatinine Ratio (UACR) = 200 and < 5,000 mg/g in spot urine (midstream urine sample) by central laboratory analysis at Visit 1.1
* If the patient is taking any of the following medications they should be on a stable dose for at least 4 weeks prior to visit 1 and until first randomisation prior to run-in with no planned change of the therapy during the trial: anti-hypertensives, Nonsteroidal Anti-Inflammatory Drugs (NSAIDs), endothelin receptor antagonists, low dose systemic steroids (e.g. prednisolone =10 mg or equivalent).
* Treatment with a clinically appropriate, stable dose of either Angiotensin-Converting Enzyme Inhibitor (ACEi) or Angiotensin Receptor Blocker (ARB) (but not both together), for = 4 weeks prior to visit 1 and until first randomisation with no planned change of the therapy during the trial.
* In the Investigator's opinion, any kind of diagnosed chronic kidney disease (Diagnosis can be reached by standard clinical method, no biopsy required). Patients with diabetic kidney disease must have type 2 diabetes mellitus and their treatment (including GLP1 receptor agonist) should be unchanged or changes deemed minor (according to investigator's judgement) within 4 weeks prior to Visit 1 and until first randomisation.
* Glycated Haemoglobin (HbA1c) < 10.0% at Visit 1 measured by the central laboratory.
* Serum potassium = 4.8 mmol/L at Visit 1 measured by the central laboratory.
* Seated Systolic Blood Pressure (SBP) = 110 and = 160 mmHg and Diastolic Blood Pressure (DBP) = 65 and = 110 mmHg at Visit 1 (mean values from three Blood Pressure (BP) measurements) and optimised anti-hypertensive treatment according to local standard of care and investigator's judgement.
* Body Mass Index (BMI) = 18.5 and < 50 kg/m2 at Visit 1.
* Women of child-bearing potential2 (WOCBP) must be ready and able to use highly effective methods of birth control. Such methods should be used throughout the trial. Men must be vasectomised or willing and able to use a condom if their partner is a WOCBP.

Additional inclusion criteria to be assessed before second randomisation (start of Treatment Period):

* Serum potassium = 4.8 mmol/L measured by local or central laboratory within 7 days prior to randomisation to the Treatment Period.
* eGFR (Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] formula) = 20 mL/min/1.73 m2 measured by local or central laboratory within 7 days prior to randomisation to the Treatment Period.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria

* Treatment with inhibitors of aldosterone mediated effects (e.g., mineralocorticoid receptor antagonists such as spironolactone), or intake of other potassium sparing diuretics (e.g., amiloride) within 7 days prior to first randomisation or planned during trial treatment phase.
* Treatment with other Renin Angiotensin Aldosterone System (RAAS) interventions (apart from either Angiotensin-Converting Enzyme Inhibitor (ACEi) or Angiotensin Receptor Blocker (ARB)) within 4 weeks prior to Visit 1 and throughout screening or planned during the trial. Patients who must or wish to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial are also excluded.
* Type 1 diabetes mellitus, or history of other autoimmune causes of diabetes mellitus (e.g. Latent Autoimmune Diabetes (LADA))
* Patients at increased risk of ketoacidosis in the opinion of the investigator.
* Currently receiving Sodium-glucose cotransporter (SGLT)-2 or SGLT-1/2 inhibitor or planned initiation during the trial.

Further criteria apply.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
11/01/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
10/07/2023
Sample size
Target
Accrual to date
Final
714
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
John Hunter Hospital - New Lambton Heights
Recruitment hospital [2] 0 0
Monash University - Box Hill
Recruitment hospital [3] 0 0
St Vincent's Hospital Melbourne - Fitzroy
Recruitment postcode(s) [1] 0 0
2305 - New Lambton Heights
Recruitment postcode(s) [2] 0 0
3128 - Box Hill
Recruitment postcode(s) [3] 0 0
3065 - Fitzroy
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Idaho
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Kansas
Country [8] 0 0
United States of America
State/province [8] 0 0
Michigan
Country [9] 0 0
United States of America
State/province [9] 0 0
Missouri
Country [10] 0 0
United States of America
State/province [10] 0 0
Nevada
Country [11] 0 0
United States of America
State/province [11] 0 0
New Mexico
Country [12] 0 0
United States of America
State/province [12] 0 0
North Carolina
Country [13] 0 0
United States of America
State/province [13] 0 0
Ohio
Country [14] 0 0
United States of America
State/province [14] 0 0
Pennsylvania
Country [15] 0 0
United States of America
State/province [15] 0 0
South Dakota
Country [16] 0 0
United States of America
State/province [16] 0 0
Tennessee
Country [17] 0 0
United States of America
State/province [17] 0 0
Texas
Country [18] 0 0
United States of America
State/province [18] 0 0
Washington
Country [19] 0 0
Argentina
State/province [19] 0 0
Buenos Aires
Country [20] 0 0
Argentina
State/province [20] 0 0
Caba
Country [21] 0 0
Argentina
State/province [21] 0 0
Ciudad Autonoma Buenos Aires
Country [22] 0 0
Argentina
State/province [22] 0 0
Cordoba
Country [23] 0 0
Argentina
State/province [23] 0 0
Junín
Country [24] 0 0
Argentina
State/province [24] 0 0
Mar del Plata
Country [25] 0 0
Argentina
State/province [25] 0 0
Rosario
Country [26] 0 0
Argentina
State/province [26] 0 0
Villa Luro
Country [27] 0 0
Belgium
State/province [27] 0 0
Brussel
Country [28] 0 0
Belgium
State/province [28] 0 0
Bruxelles
Country [29] 0 0
Belgium
State/province [29] 0 0
La Louvière
Country [30] 0 0
Belgium
State/province [30] 0 0
Leuven/Vlaams-Brabant
Country [31] 0 0
Belgium
State/province [31] 0 0
Lodelinsart
Country [32] 0 0
Brazil
State/province [32] 0 0
Belém
Country [33] 0 0
Brazil
State/province [33] 0 0
Botucatu
Country [34] 0 0
Brazil
State/province [34] 0 0
Curitiba
Country [35] 0 0
Brazil
State/province [35] 0 0
Porto Alegre
Country [36] 0 0
Brazil
State/province [36] 0 0
Rio de Janeiro
Country [37] 0 0
Brazil
State/province [37] 0 0
Sao Paulo
Country [38] 0 0
Brazil
State/province [38] 0 0
São Bernardo do Campo
Country [39] 0 0
Brazil
State/province [39] 0 0
São Paulo
Country [40] 0 0
Bulgaria
State/province [40] 0 0
Ruse
Country [41] 0 0
Bulgaria
State/province [41] 0 0
Sofia
Country [42] 0 0
Bulgaria
State/province [42] 0 0
Stara Zagora
Country [43] 0 0
Canada
State/province [43] 0 0
Alberta
Country [44] 0 0
Canada
State/province [44] 0 0
Ontario
Country [45] 0 0
Canada
State/province [45] 0 0
Quebec
Country [46] 0 0
China
State/province [46] 0 0
Guangzhou
Country [47] 0 0
China
State/province [47] 0 0
Hangzhou
Country [48] 0 0
China
State/province [48] 0 0
Nanning
Country [49] 0 0
China
State/province [49] 0 0
Shanghai
Country [50] 0 0
Czechia
State/province [50] 0 0
Havirov
Country [51] 0 0
Czechia
State/province [51] 0 0
Prague
Country [52] 0 0
Czechia
State/province [52] 0 0
Pribram
Country [53] 0 0
Czechia
State/province [53] 0 0
Slany
Country [54] 0 0
Finland
State/province [54] 0 0
Kuopio
Country [55] 0 0
Finland
State/province [55] 0 0
Tampere
Country [56] 0 0
Finland
State/province [56] 0 0
Turku
Country [57] 0 0
Germany
State/province [57] 0 0
Bad Oeynhausen
Country [58] 0 0
Germany
State/province [58] 0 0
Berlin
Country [59] 0 0
Germany
State/province [59] 0 0
Dresden
Country [60] 0 0
Germany
State/province [60] 0 0
Düsseldorf
Country [61] 0 0
Germany
State/province [61] 0 0
Frankfurt
Country [62] 0 0
Germany
State/province [62] 0 0
Hannover
Country [63] 0 0
Germany
State/province [63] 0 0
Leipzig
Country [64] 0 0
Germany
State/province [64] 0 0
Würzburg
Country [65] 0 0
Greece
State/province [65] 0 0
Athens
Country [66] 0 0
Greece
State/province [66] 0 0
Ioannina
Country [67] 0 0
Greece
State/province [67] 0 0
P. Faliro
Country [68] 0 0
Hong Kong
State/province [68] 0 0
Hong Kong
Country [69] 0 0
Hungary
State/province [69] 0 0
Baja
Country [70] 0 0
Hungary
State/province [70] 0 0
Balatonfured
Country [71] 0 0
Hungary
State/province [71] 0 0
Budapest
Country [72] 0 0
Hungary
State/province [72] 0 0
Debrecen
Country [73] 0 0
Hungary
State/province [73] 0 0
Eger
Country [74] 0 0
Hungary
State/province [74] 0 0
Hatvan
Country [75] 0 0
India
State/province [75] 0 0
Aurangabad
Country [76] 0 0
India
State/province [76] 0 0
Jaipur
Country [77] 0 0
India
State/province [77] 0 0
Kanpur
Country [78] 0 0
India
State/province [78] 0 0
Mysore
Country [79] 0 0
India
State/province [79] 0 0
Nagpur
Country [80] 0 0
India
State/province [80] 0 0
New Delhi
Country [81] 0 0
India
State/province [81] 0 0
Rajkot
Country [82] 0 0
India
State/province [82] 0 0
Varanasi
Country [83] 0 0
India
State/province [83] 0 0
Vellore
Country [84] 0 0
Italy
State/province [84] 0 0
Bari
Country [85] 0 0
Italy
State/province [85] 0 0
Bergamo
Country [86] 0 0
Japan
State/province [86] 0 0
Aichi, Ichinomiya
Country [87] 0 0
Japan
State/province [87] 0 0
Aichi, Nagoya
Country [88] 0 0
Japan
State/province [88] 0 0
Gumma, Takasaki
Country [89] 0 0
Japan
State/province [89] 0 0
Kyoto, Kuse-gun
Country [90] 0 0
Japan
State/province [90] 0 0
Nagano, Ina
Country [91] 0 0
Japan
State/province [91] 0 0
Nagano, Suwa
Country [92] 0 0
Japan
State/province [92] 0 0
Saitama, Kawagoe
Country [93] 0 0
Japan
State/province [93] 0 0
Shiga, Omihachiman
Country [94] 0 0
Japan
State/province [94] 0 0
Tokyo, Bunkyo-ku
Country [95] 0 0
Japan
State/province [95] 0 0
Tokyo, Hachioji
Country [96] 0 0
Japan
State/province [96] 0 0
Tokyo, Shinagawa-ku
Country [97] 0 0
Japan
State/province [97] 0 0
Ueda, Nagano
Country [98] 0 0
Korea, Republic of
State/province [98] 0 0
Ansan
Country [99] 0 0
Korea, Republic of
State/province [99] 0 0
Cheongiu
Country [100] 0 0
Korea, Republic of
State/province [100] 0 0
Goyang
Country [101] 0 0
Korea, Republic of
State/province [101] 0 0
Seoul
Country [102] 0 0
Malaysia
State/province [102] 0 0
Batu Caves
Country [103] 0 0
Malaysia
State/province [103] 0 0
Cheras, Kuala Lumpur
Country [104] 0 0
Malaysia
State/province [104] 0 0
Johor Bahru
Country [105] 0 0
Malaysia
State/province [105] 0 0
Kangar
Country [106] 0 0
Malaysia
State/province [106] 0 0
Kota Bharu
Country [107] 0 0
Malaysia
State/province [107] 0 0
Seri Manjung
Country [108] 0 0
Mexico
State/province [108] 0 0
Aguascalientes
Country [109] 0 0
Mexico
State/province [109] 0 0
Guadalajara
Country [110] 0 0
Mexico
State/province [110] 0 0
Mexico
Country [111] 0 0
Mexico
State/province [111] 0 0
México
Country [112] 0 0
Mexico
State/province [112] 0 0
Nuevo León
Country [113] 0 0
Norway
State/province [113] 0 0
Nordbyhagen
Country [114] 0 0
Norway
State/province [114] 0 0
Stavanger
Country [115] 0 0
Philippines
State/province [115] 0 0
Cebu City
Country [116] 0 0
Philippines
State/province [116] 0 0
Davao City
Country [117] 0 0
Philippines
State/province [117] 0 0
Iloilo City
Country [118] 0 0
Philippines
State/province [118] 0 0
Marikina city
Country [119] 0 0
Philippines
State/province [119] 0 0
Pasig City
Country [120] 0 0
Philippines
State/province [120] 0 0
Quezon City
Country [121] 0 0
Philippines
State/province [121] 0 0
Tarlac
Country [122] 0 0
Poland
State/province [122] 0 0
Bydgoszcz
Country [123] 0 0
Poland
State/province [123] 0 0
Gdansk
Country [124] 0 0
Poland
State/province [124] 0 0
Katowice
Country [125] 0 0
Poland
State/province [125] 0 0
Lodz
Country [126] 0 0
Poland
State/province [126] 0 0
Lublin
Country [127] 0 0
Poland
State/province [127] 0 0
Pomorskie
Country [128] 0 0
Poland
State/province [128] 0 0
Poznan
Country [129] 0 0
Poland
State/province [129] 0 0
Warszawa
Country [130] 0 0
Poland
State/province [130] 0 0
Wroclaw
Country [131] 0 0
Portugal
State/province [131] 0 0
Almada
Country [132] 0 0
Portugal
State/province [132] 0 0
Aveiro
Country [133] 0 0
Portugal
State/province [133] 0 0
Carnaxide
Country [134] 0 0
Portugal
State/province [134] 0 0
Leiria
Country [135] 0 0
Portugal
State/province [135] 0 0
Lisboa
Country [136] 0 0
Portugal
State/province [136] 0 0
Vila Nova de Gaia
Country [137] 0 0
South Africa
State/province [137] 0 0
Bloemfontein
Country [138] 0 0
South Africa
State/province [138] 0 0
Cape Town
Country [139] 0 0
South Africa
State/province [139] 0 0
Durban
Country [140] 0 0
South Africa
State/province [140] 0 0
Krugersdorp
Country [141] 0 0
South Africa
State/province [141] 0 0
Pretoria
Country [142] 0 0
Spain
State/province [142] 0 0
Barcelona
Country [143] 0 0
Spain
State/province [143] 0 0
Burela
Country [144] 0 0
Spain
State/province [144] 0 0
Córdoba
Country [145] 0 0
Spain
State/province [145] 0 0
Madrid
Country [146] 0 0
Spain
State/province [146] 0 0
Majadahonda
Country [147] 0 0
Sweden
State/province [147] 0 0
Kristianstad
Country [148] 0 0
Sweden
State/province [148] 0 0
Linköping
Country [149] 0 0
Sweden
State/province [149] 0 0
Stockholm
Country [150] 0 0
Switzerland
State/province [150] 0 0
Lausanne
Country [151] 0 0
Turkey
State/province [151] 0 0
Istanbul

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Boehringer Ingelheim
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Once the time frame criteria given under number 4 are fulfilled, researchers can use the following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".

Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
After structured results have been posted, all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
Available to whom?
For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.mystudywindow.com/msw/datasharing


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT05182840