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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03819153




Registration number
NCT03819153
Ethics application status
Date submitted
18/01/2019
Date registered
28/01/2019

Titles & IDs
Public title
A Research Study to See How Semaglutide Works Compared to Placebo in People With Type 2 Diabetes and Chronic Kidney Disease
Scientific title
Effect of Semaglutide Versus Placebo on the Progression of Renal Impairment in Subjects With Type 2 Diabetes and Chronic Kidney Disease
Secondary ID [1] 0 0
U1111-1217-6259
Secondary ID [2] 0 0
NN9535-4321
Universal Trial Number (UTN)
Trial acronym
FLOW
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus, Type 2 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
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Semaglutide
Treatment: Drugs - Placebo (semaglutide)

Experimental: Semaglutide - Participants are to receive semglutide for up to 5 years or more (event driven). The trial is event driven with a pre-defined minimum number of renal endpoint events for the primary endpoint.

Placebo comparator: Placebo - Participants are to receive placebo (semglutide) for up to 5 years or more (event driven). The trial is event driven with a pre-defined minimum number of renal endpoint events for the primary endpoint.


Treatment: Drugs: Semaglutide
Participants are to inject semaglutide with a needle in the stomach, thigh or upper arm. Participants will use a pen to inject semaglutide under their skin. Participants will inject semaglutide 1 time a week on the same day of the week. Participants' dose of semaglutide will be changed over time. Participants start by taking a smaller amount (0.25 mg). After 4 weeks the dose will be increased to 0.5 mg. It will be increased more (to 1 mg) at 8 weeks. Participants will then stay on the same dose for the rest of the study.

Treatment: Drugs: Placebo (semaglutide)
Participants are to inject placebo (semaglutide) with a needle in the stomach, thigh or upper arm. Participants will use a pen to inject placebo (semaglutide) under their skin. Participants will inject placebo (semaglutide) 1 time a week on the same day of the week. Participants' dose of placebo (semaglutide) will be changed over time. Participants start by taking a smaller amount (0.25 mg). After 4 weeks the dose will be increased to 0.5 mg. It will be increased more (to 1 mg) at 8 weeks. Participants will then stay on the same dose for the rest of the study.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to first occurrence of a composite primary outcome event defined as persistent eGFR decline of greater than or equal to 50 percentage from trial start, reaching ESRD, death from kidney disease or death from cardiovascular disease
Timepoint [1] 0 0
Week 0 to month 61
Secondary outcome [1] 0 0
Annual rate of change in eGFR (chronic kidney disease - epidemiology collaboration (CKD-EPI)) (total eGFR slope)
Timepoint [1] 0 0
Week 0 to month 61
Secondary outcome [2] 0 0
Time to first occurrence of a composite cardiovascular major adverse cardiovascular event (MACE) endpoint consisting of: Non-fatal myocardial infarction, non-fatal stroke, and cardiovascular (CV) death
Timepoint [2] 0 0
Week 0 to month 61
Secondary outcome [3] 0 0
Time to occurrence of all-cause death
Timepoint [3] 0 0
Week 0 to month 61
Secondary outcome [4] 0 0
Time to occurrence of each of the individual components of the primary composite endpoint and of the confirmatory secondary MACE endpoint
Timepoint [4] 0 0
Week 0 to month 61
Secondary outcome [5] 0 0
Time to first occurrence of major adverse limb events (MALE), a composite endpoint consisting of: Acute limb ischemia hospitalisation and chronic limb ischemia hospitalisation
Timepoint [5] 0 0
Week 0 to month 61
Secondary outcome [6] 0 0
Annual rate of change in eGFR (CKD-EPI) (chronic eGFR slope)
Timepoint [6] 0 0
Week 12 to month 61
Secondary outcome [7] 0 0
Change in eGFR (CKD-EPI)
Timepoint [7] 0 0
Week 0, Week 12
Secondary outcome [8] 0 0
Change in eGFR (cystatin C CKD-EPI)
Timepoint [8] 0 0
Week 0, Year 3
Secondary outcome [9] 0 0
Relative change in urinary albumin-to-creatinine ratio (UACR)
Timepoint [9] 0 0
Week 0, Year 3
Secondary outcome [10] 0 0
Change in body weight
Timepoint [10] 0 0
Week 0, Year 3
Secondary outcome [11] 0 0
Change in glycosylated haemoglobin (HbA1c)
Timepoint [11] 0 0
Week 0, Year 3
Secondary outcome [12] 0 0
Change in systolic blood pressure
Timepoint [12] 0 0
Week 0, Year 3
Secondary outcome [13] 0 0
Change in diastolic blood pressure
Timepoint [13] 0 0
Week 0, Year 3
Secondary outcome [14] 0 0
Number of severe hypoglycaemic episodes
Timepoint [14] 0 0
Week 0 to month 61

Eligibility
Key inclusion criteria
* Male or female, age above or equal to 18 years at the time of signing informed consent. Japan: Male or female, age above or equal to 20 years at the time of signing informed consent
* Diagnosed with type 2 diabetes mellitus
* HbA1c less than or equal to 10% (less than or equal to 86 mmol/mol)
* Renal impairment defined either by:

1. serum creatinine-based eGFR greater than or equal to 50 and less than or equal to 75 mL/min/1.73 m^2 (CKD-EPI) and UACR greater than 300 and less than 5000 mg/g or
2. serum creatinine-based eGFR greater than or equal to 25 and less than 50 mL/min/1.73 m^2 (CKD-EPI) and UACR greater than 100 and less than 5000 mg/g
* Treatment with maximum labelled or tolerated dose of a renin-angiotensin-aldosterone system (RAAS) blocking agent including an angiotensin converting enzyme (ACE) inhibitor or an angiotensin II receptor blocker (ARB), unless such treatment is contraindicated or not tolerated. Treatment dose must be stable for at least 4 weeks prior to the date of the laboratory assessments used for determination of the inclusion criteria for renal impairment and kept stable until screening
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Congenital or hereditary kidney diseases including polycystic kidney disease, autoimmune kidney diseases including glomerulonephritis or congenital urinary tract malformations
* Use of any glucagon-like peptide-1 (GLP-1) receptor agonist within 30 days prior to screening
* Myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischaemic attack within 60 days prior to the day of screening
* Presently classified as being in New York Heart Association (NYHA) Class IV heart failure
* Planned coronary, carotid or peripheral artery revascularisation
* Current (or within 90 days) chronic or intermittent haemodialysis or peritoneal dialysis
* Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days prior to screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination

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 3
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
17/06/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
9/01/2024
Sample size
Target
Accrual to date
Final
3508
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Gosford Renal Research - Gosford
Recruitment hospital [2] 0 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [3] 0 0
Westmead Hospital_Northmead - Westmead
Recruitment hospital [4] 0 0
Core Research Centre - Milton
Recruitment hospital [5] 0 0
Monash Health Nephrology - Clayton
Recruitment hospital [6] 0 0
St Vincent's Hospital_Fitzroy_0 - Fitzroy
Recruitment hospital [7] 0 0
Monash University Clinical Trial Centre - Melbourne
Recruitment hospital [8] 0 0
The Royal Melbourne Hospital - Parkville
Recruitment postcode(s) [1] 0 0
2250 - Gosford
Recruitment postcode(s) [2] 0 0
2065 - St Leonards
Recruitment postcode(s) [3] 0 0
2145 - Westmead
Recruitment postcode(s) [4] 0 0
4064 - Milton
Recruitment postcode(s) [5] 0 0
3168 - Clayton
Recruitment postcode(s) [6] 0 0
3065 - Fitzroy
Recruitment postcode(s) [7] 0 0
3004 - Melbourne
Recruitment postcode(s) [8] 0 0
3050 - Parkville
Recruitment outside Australia
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State/province [191] 0 0
Valencia
Country [192] 0 0
Thailand
State/province [192] 0 0
Bangkok
Country [193] 0 0
Thailand
State/province [193] 0 0
Mueang Chiang Mai District
Country [194] 0 0
Turkey
State/province [194] 0 0
Ankara
Country [195] 0 0
Turkey
State/province [195] 0 0
Antalya
Country [196] 0 0
Turkey
State/province [196] 0 0
Aydin
Country [197] 0 0
Turkey
State/province [197] 0 0
Istanbul
Country [198] 0 0
Turkey
State/province [198] 0 0
Izmir
Country [199] 0 0
Turkey
State/province [199] 0 0
Kahramanmaras
Country [200] 0 0
Turkey
State/province [200] 0 0
Kocaeli
Country [201] 0 0
Ukraine
State/province [201] 0 0
Dnipro
Country [202] 0 0
Ukraine
State/province [202] 0 0
Ivano-Frankivsk
Country [203] 0 0
Ukraine
State/province [203] 0 0
Kharkiv
Country [204] 0 0
Ukraine
State/province [204] 0 0
Kyiv
Country [205] 0 0
Ukraine
State/province [205] 0 0
Poltava
Country [206] 0 0
Ukraine
State/province [206] 0 0
Zaporizhia
Country [207] 0 0
United Kingdom
State/province [207] 0 0
Aberdeen
Country [208] 0 0
United Kingdom
State/province [208] 0 0
Birmingham
Country [209] 0 0
United Kingdom
State/province [209] 0 0
Cardiff
Country [210] 0 0
United Kingdom
State/province [210] 0 0
Dundee
Country [211] 0 0
United Kingdom
State/province [211] 0 0
Edinburgh
Country [212] 0 0
United Kingdom
State/province [212] 0 0
Glasgow
Country [213] 0 0
United Kingdom
State/province [213] 0 0
Ipswich
Country [214] 0 0
United Kingdom
State/province [214] 0 0
London
Country [215] 0 0
United Kingdom
State/province [215] 0 0
Stevenage
Country [216] 0 0
United Kingdom
State/province [216] 0 0
Tooting

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novo Nordisk A/S
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Clinical Transparency (dept. 1452)
Address 0 0
Novo Nordisk A/S
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?
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.novonordisk-trials.com


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03819153