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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/NCT03819153




Registration number
NCT03819153
Ethics application status
Date submitted
18/01/2019
Date registered
28/01/2019
Date last updated
10/06/2024

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
Active, not recruiting
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
19/08/2024
Actual
Sample size
Target
3508
Accrual to date
Final
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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Spain
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Mueang Chiang Mai District
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Turkey
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Ankara
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Antalya
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Aydin
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Izmir
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Kocaeli
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Ukraine
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Dnipro
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Ivano-Frankivsk
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Tooting

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

Ethics approval
Ethics application status

Summary
Brief summary
The researchers are doing this study to see if semaglutide can slow down the growth and
worsening of chronic kidney disease in people with type 2 diabetes. Participants will get
semaglutide (active medicine) or placebo ('dummy medicine'). This is known as participants'
study medicine - which treatment participants get is decided by chance. Semaglutide is a
medicine, doctors can prescribe in some countries for the treatment of type 2 diabetes.
Participants will get the study medicine in a pen. Participants will use the pen to inject
the medicine in a skin fold once a week. The study will close when there is enough
information collected to show clear result of the study. The total time participants will be
in this study is about 3 to 5 years, but it could be longer.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03819153
Trial related presentations / publications
Rossing P, Baeres FMM, Bakris G, Bosch-Traberg H, Gislum M, Gough SCL, Idorn T, Lawson J, Mahaffey KW, Mann JFE, Mersebach H, Perkovic V, Tuttle K, Pratley R. The rationale, design and baseline data of FLOW, a kidney outcomes trial with once-weekly semaglutide in people with type 2 diabetes and chronic kidney disease. Nephrol Dial Transplant. 2023 Aug 31;38(9):2041-2051. doi: 10.1093/ndt/gfad009. Erratum In: Nephrol Dial Transplant. 2024 Mar 27;39(4):724.
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03819153