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FLOW - effect of semaglutide v placebo on renal impairment in individuals with type 2 diabetes and chronic kidney disease

University of North Carolina at Chapel Hill


Description

Chronic kidney disease (CKD) and diabetes often co-exist and, for the majority of cases, the kidney damage and/or reduced kidney function is caused directly by longstanding and poorly controlled diabetes. Improved glycemic control has been suggested to reduce the progression of CKD in type 2 diabetes (T2D) and both glycemic and blood pressure control are key recommendations in international treatment guidelines for CKD in T2D. Yet there remains a major unmet medical need to improve the treatment of CKD in patients with T2D. The purpose of this trial is to demonstrate that semaglutide subcutaneously (s.c.) delays the progression of renal impairment and lowers the risk of renal and cardiovascular mortality in subjects with T2D and CKD.


Keywords:

Diabetes, Kidneys


Category:

Drug or Biologic
Phase:3

Qualifications

 


Age
18 - 99 years


Gender
Any


Study Population

Male or female, 18 years or older. Must be diagnosed with type 2 diabetes and have an HbA1c < or = 10%. Must have renal impairment (based on eGFR and UACR). Must be treated with maximum labelled or maximum tolerated RAAS blocking agent, including an ACE inhibitor or ARB.


Investigator

Marian Kirkman
Clinical Professor
Medicine-Endocrinology

For questions, contact:

Megan Sweeney
megan_sweeney@med.unc.edu
(984) 974-3001


Recruitment Period End

February 1, 2021

Location

Primary Location
UNC Diabetes Care Center
300 Meadowmont Village Cir, Chapel Hill, NC 27517, USA

Study Qualifications

Gender Any

Age Range 18 - 99 years

Participant qualification(s) 1. Male or female, 18 years or older 2. Diagnosed with type 2 diabetes 3. HbA1c < or = 10% 4. Renal impairment defined by laboratory values (eGFR and UACR) 5. Treatment with maximum labelled or maximum tolerated RAAS blocking agent, including an ACE inhibitor or ARB.

Not eligible if: 1. Female who is pregnant, breast-feeding, or intends to become pregnant 2. Use of a GLP-1 receptor agonist within 30 days prior to screening 3. Current chronic or intermittent hemodialysis or peritoneal dialysis 4. Combination use of an ACE inhibitor and ARB

Number of Visits

    » 17 In person visit(s)

    1 screening, 1 randomization, 9-13 treatment period visits, 1 end of treatment visit, 1 follow-up

    » 11 Remote visit(s)

    7-11 phone visits

Participation Period

3-5 years

Compensation

$50 for in-person visits, $25 for phone visits

By clicking I am interested, your contact information will be sent to the researcher/study coordinator for this study. The coordinator will respond by email with additional information on how to proceed.