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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05182840




Registration number
NCT05182840
Ethics application status
Date submitted
5/01/2022
Date registered
10/01/2022
Date last updated
2/10/2023

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: Treatment period: Empagliflozin + BI 690517 -

Experimental: Treatment period: Empagliflozin + Placebo to BI 690517 -

Experimental: Treatment period: Placebo to Empagliflozin + BI 690517 -

Placebo Comparator: Treatment period: Placebo to Empagliflozin + Placebo to BI 690517 -


Treatment: Drugs: BI 690517
BI 690517

Treatment: Drugs: Placebo to BI 690517
Placebo to BI 690517

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 urine
Timepoint [1] 0 0
up to 14 weeks
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
Timepoint [1] 0 0
up to 14 weeks
Secondary outcome [2] 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
Timepoint [2] 0 0
up to 14 weeks

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
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John Hunter Hospital - New Lambton Heights
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Monash University - Box Hill
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St Vincent's Hospital Melbourne - Fitzroy
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2305 - New Lambton Heights
Recruitment postcode(s) [2] 0 0
3128 - Box Hill
Recruitment postcode(s) [3] 0 0
3065 - Fitzroy
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Durban
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Pretoria
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Barcelona
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Istanbul

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

Ethics approval
Ethics application status

Summary
Brief summary
This study is open to adults with chronic kidney disease. People with and without type 2
diabetes can take part in this study.

The purpose of this study is to find out whether a medicine called BI 690517 improves kidney
function in people with chronic kidney disease when taken alone or in combination with a
medicine called empagliflozin.

In the first part of the study, participants take empagliflozin or placebo as tablets every
day for 2 months. Placebo tablets look like empagliflozin tablets but do not contain any
medicine.

In the second part, participants are divided into several groups. Depending on the group, the
participants then additionally take different doses of BI 690517 or placebo as tablets for
3.5 months. In this case, placebo tablets look like BI 690517 tablets but do not contain any
medicine.

Participants are in the study for about 6 months. During this time, they visit the study site
about 12 times. Where possible, about 4 of the 12 visits can be done at the participant's
home instead of the study site. The trial staff may also contact the participants by phone or
video call.

Participants collect urine samples at home. These samples are then analysed to assess kidney
function. At the end of the trial the results are compared between the different groups. The
doctors also regularly check participants' health and take note of any unwanted effects.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05182840
Trial related presentations / publications
Public notes

Contacts
Principal investigator
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Contact person for public queries
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Contact person for scientific queries