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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
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Scientific title
Effect of Semaglutide Versus Placebo on the Progression of Renal Impairment in Subjects With Type 2 Diabetes and Chronic Kidney Disease
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Secondary ID [1]
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U1111-1217-6259
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Secondary ID [2]
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NN9535-4321
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Universal Trial Number (UTN)
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Trial acronym
FLOW
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus, Type 2
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Condition category
Condition code
Renal and Urogenital
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Kidney disease
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Renal and Urogenital
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Other renal and urogenital disorders
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Metabolic and Endocrine
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0
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Diabetes
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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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
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Assessment method [1]
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Measured in month(s). End Stage Renal Disease (ESRD) is defined as the following individual components: Persistent estimated glomerular filtration rate (eGFR) less than 15 mL/min/1.73m\^2 or, Chronic dialysis treatment or receiving a kidney transplantation.
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Timepoint [1]
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Week 0 to month 61
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Secondary outcome [1]
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Annual rate of change in eGFR (chronic kidney disease - epidemiology collaboration (CKD-EPI)) (total eGFR slope)
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Assessment method [1]
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Measured in (mL/min/1.73 m\^2)/year.
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Timepoint [1]
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Week 0 to month 61
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Secondary outcome [2]
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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
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Assessment method [2]
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Measured in month(s).
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Timepoint [2]
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Week 0 to month 61
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Secondary outcome [3]
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Time to occurrence of all-cause death
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Assessment method [3]
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Measured in month(s).
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Timepoint [3]
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Week 0 to month 61
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Secondary outcome [4]
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Time to occurrence of each of the individual components of the primary composite endpoint and of the confirmatory secondary MACE endpoint
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Assessment method [4]
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Measured in month(s).
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Timepoint [4]
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Week 0 to month 61
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Secondary outcome [5]
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Time to first occurrence of major adverse limb events (MALE), a composite endpoint consisting of: Acute limb ischemia hospitalisation and chronic limb ischemia hospitalisation
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Assessment method [5]
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Measured in month(s).
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Timepoint [5]
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Week 0 to month 61
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Secondary outcome [6]
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Annual rate of change in eGFR (CKD-EPI) (chronic eGFR slope)
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Assessment method [6]
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Measured in (mL/min/1.73 m\^2)/year.
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Timepoint [6]
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Week 12 to month 61
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Secondary outcome [7]
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Change in eGFR (CKD-EPI)
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Assessment method [7]
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Measured in mL/min/1.73 m\^2.
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Timepoint [7]
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Week 0, Week 12
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Secondary outcome [8]
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Change in eGFR (cystatin C CKD-EPI)
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Assessment method [8]
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Measured in mL/min/1.73 m\^2.
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Timepoint [8]
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Week 0, Year 3
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Secondary outcome [9]
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Relative change in urinary albumin-to-creatinine ratio (UACR)
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Assessment method [9]
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Measured in percentage.
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Timepoint [9]
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Week 0, Year 3
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Secondary outcome [10]
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Change in body weight
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Assessment method [10]
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Measured in kilogram.
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Timepoint [10]
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Week 0, Year 3
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Secondary outcome [11]
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Change in glycosylated haemoglobin (HbA1c)
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Assessment method [11]
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Measured in percentage point.
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Timepoint [11]
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Week 0, Year 3
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Secondary outcome [12]
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Change in systolic blood pressure
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Assessment method [12]
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Measured in mmHg.
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Timepoint [12]
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Week 0, Year 3
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Secondary outcome [13]
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Change in diastolic blood pressure
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Assessment method [13]
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Measured in mmHg.
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Timepoint [13]
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Week 0, Year 3
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Secondary outcome [14]
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Number of severe hypoglycaemic episodes
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Assessment method [14]
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Number of events.
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Timepoint [14]
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Week 0 to month 61
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
17/06/2019
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
9/01/2024
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Sample size
Target
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Accrual to date
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Final
3508
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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Recruitment hospital [1]
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Gosford Renal Research - Gosford
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Recruitment hospital [2]
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Royal North Shore Hospital - St Leonards
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Westmead Hospital_Northmead - Westmead
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Recruitment hospital [4]
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Core Research Centre - Milton
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Recruitment hospital [5]
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Monash Health Nephrology - Clayton
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Recruitment hospital [6]
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St Vincent's Hospital_Fitzroy_0 - Fitzroy
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Recruitment hospital [7]
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Monash University Clinical Trial Centre - Melbourne
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Recruitment hospital [8]
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The Royal Melbourne Hospital - Parkville
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Recruitment postcode(s) [1]
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2250 - Gosford
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Recruitment postcode(s) [2]
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2065 - St Leonards
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Recruitment postcode(s) [3]
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2145 - Westmead
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Recruitment postcode(s) [4]
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4064 - Milton
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Recruitment postcode(s) [5]
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3168 - Clayton
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Recruitment postcode(s) [6]
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3065 - Fitzroy
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Recruitment postcode(s) [7]
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3004 - Melbourne
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Recruitment postcode(s) [8]
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3050 - Parkville
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Recruitment outside Australia
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Alabama
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California
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Caen
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India
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Nitra
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Presov
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Trebisov
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Stevenage
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Tooting
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Novo Nordisk A/S
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Ethics approval
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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.
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Trial website
https://clinicaltrials.gov/study/NCT03819153
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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. doi: 10.1093/ndt/gfad252. Cohen S, Sternlicht H, Bakris GL. Mineralocorticoid Receptor Antagonists in the Treatment of Diabetic Kidney Disease: Their Application in the Era of SGLT2 Inhibitors and GLP-1 Receptor Agonists. Curr Diab Rep. 2022 May;22(5):213-218. doi: 10.1007/s11892-022-01461-4. Epub 2022 Apr 20.
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Public notes
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Contacts
Principal investigator
Name
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0
Clinical Transparency (dept. 1452)
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Address
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Novo Nordisk A/S
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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When will data be available (start and end dates)?
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Available to whom?
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://www.novonordisk-trials.com
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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