Effect of Subcutaneous Semaglutide on Kidney Transplant Candidacy

NCT04741074 | Terminated Phase 3 Results DMC FDA Drug

• 2 other identifiers: 2020-1050Universal Trial Number
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

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

Keywords

ckd; obesity; kidney transplant; transplant wait list; diabetic kidney disease; glp-1; semaglutide

Outcome Measures

Primary Outcomes (1)

• Kidney Transplant Eligibility

  Proportion either listed for kidney transplant at 9 months or meeting the following kidney transplant candidacy criteria for A1c (\<9%) and obesity (BMI \<35 kg/m2 or BMI 35-40 kg/m2 with waist circumference \<120 cm)

  Ascertained at the end of 9 months

Secondary Outcomes (7)

• Change in Hemoglobin A1c (HgbA1c)

  From baseline to 9 months

• Change in BMI

  From baseline to 9 months

• Change in Waist Circumference

  From baseline to 9 months

• Change in Waist-to-hip Ratio

  From baseline to 9 months

• Change in Body Fat Percentage

  From baseline to 9 months

Other Outcomes (18)

• Change in Low-Density Lipoprotein (LDL)

  Baseline to 9 months

• Change in Triglycerides

  Baseline to 9 months

• Change in Systolic Blood Pressure

  Baseline to 9 months

Study Arms (2)

Semaglutide

ACTIVE COMPARATOR

This arm will receive semaglutide.

Drug: Semaglutide 2 mg/1.5 ml (1.34 mg/ml), prefilled pen-injector for subcutaneous injection solution

Placebo

PLACEBO COMPARATOR

This arm will receive placebo.

Drug: Placebo 1.5 ml, prefilled pen-injector for subcutaneous injection solution

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.

Also known as: semaglutide

Semaglutide

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.

Also known as: placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Age ≥ 18 years
• \- BMI 25-45 kg/m2
• \- T2DM
• \- Advanced CKD\* (last eGFR \<30 ml/min/1.73m2 in EHR or ESKD on dialysis prior to screening) or stage G3B/A2-3 CKD (eGFR 30 to \<45 ml/min/1.73m2 with albumin/creatinine ratio \>30 mg/g).

You may not qualify if:

• \- Ability to provide informed consent before any trial-related activities
• \- Access to a telephone
• The cause of the CKD does not need to be due specifically to diabetes
• \- Active malignancy
• \- History of pancreatitis
• \- Active substance abuse
• \- Severe COPD
• \- Pulmonary fibrosis
• \- Symptomatic angina or recent myocardial infarction within 6 months
• \- Severe peripheral vascular disease
• \- Cirrhosis
• \- New York Health Association (NYHA) Class III-IV congestive heart failure
• \- Severe cognitive impairment
• \- Drug addiction
• \- History of non-adherence to therapy

Sponsors & Collaborators

• Geisinger Clinic: lead

Study Sites (2)

Geisinger Medical Center

Danville, Pennsylvania, 17821, United States

Location

Geisinger Wyoming Valley

Wilkes-Barre, Pennsylvania, 18702, United States

Location

MeSH Terms

Conditions

Diabetic Nephropathies; Obesity; Obesity, Morbid; Renal Insufficiency, Chronic

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Renal Insufficiency; Chronic Disease; Disease Attributes; Pathologic Processes

Limitations and Caveats

The study was terminated prematurely by the funder due to slow recruitment.

Results Point of Contact

• Title: Alexander Chang
• Organization: Geisinger

achang@geisinger.edu

570-271-8026

Study Officials

• Alex R Chang, MD, MS

  Geisinger Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This is a placebo-controlled double-blind clinical trial. Study investigators and participants will be blinded to treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Clinical Research

Study Record Dates

• First Submitted: February 2, 2021
• First Posted: February 5, 2021
• Study Start: July 23, 2021
• Primary Completion: January 31, 2023
• Study Completion: January 31, 2023
• Last Updated: February 9, 2024
• Results First Posted: February 9, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will become available at the time of publication of the main trial results and will be publicly available indefinitely.
• Access Criteria: The deidentified IPD will be publicly available without restrictions.

Locations

US (2)