Effect of Subcutaneous Semaglutide on Kidney Transplant Candidacy

Part of paid clinical trials in Danville, Pennsylvania.

Sponsor: Geisinger Clinic
Study ID: NCT04741074
Phase: PHASE3
Status: Terminated

Conditions

CKD
Diabetic Kidney Disease
Obesity
Severe Obesity
Type 2 Diabetes Mellitus in Obese

Eligibility Criteria

Sex: ALL
Age: 18 Years - N/A
Healthy Volunteers: Not accepted

Interventions

Semaglutide 2 mg/1.5 ml (1.34 mg/ml), prefilled pen-injector for subcutaneous injection solution — DRUG
Dose will be started at 0.25 mg per week. Dose escalation will occur every 4 weeks to mitigate risk of gastrointestinal side effects to a maximum dose of 1.0 mg per week.
Placebo 1.5 ml, prefilled pen-injector for subcutaneous injection solution — DRUG
Matched placebo solution for injection will be provided by Novo Nordisk in a 1.5 ml pre-filled pen-injector for subcutaneous injection with the same instructions on dose escalation.

Study Details

This randomized study evaluates the effect of subcutaneous semaglutide /in combination with lifestyle counseling in patients with type 2 diabetes mellitus (T2DM), overweight/obesity, and stage 4-5 chronic kidney disease (CKD) or dialysis-dependent end-stage kidney disease (ESKD) on patients' eligibility for kidney transplantation at the end of 9 months.