NCT06688825

Feasibility Study for the Comprehensive Overweight/Obesity Management Pre-Kidney Transplant (COMPKT) Program

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Virginia Commonwealth University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This project will be a single-arm feasibility study, with a treatment intervention that includes three interrelated components: (1) patient education using a proven weight loss curriculum, and (2) technology tools for making healthy lifestyle choices.

Detailed description

To optimize care for overweight/obese patients who are awaiting kidney transplants by implementing a referral process and a multi-pronged, team-based nurse/pharmacist/dietitian weight loss treatment intervention to help these patients achieve transplant criteria. Obesity, hypertension, and ESRD disproportionately affect the Black community, and Black patients have been historically disadvantaged by race-inclusive calculations that overestimated their kidney function. Effective January 5, 2023, the Organ Procurement and Transplantation Network Board of Directors requires use of a race-neutral estimated glomerular filtration rate (eGFR) to qualify candidates for kidney transplant. They also required transplant programs to identify Black candidates who may have been wrongly denied qualification

Conditions

• Kidney Transplant; Complications
• Obesity

Interventions

Type	Name	Description
BEHAVIORAL	Education regarding Weight loss	Per American Association of Clinical Endocrinology (AACE) guidelines
BEHAVIORAL	Lifestyle tools for weight loss	Calorie App, Continuous GlucosWe Monitor (CGM), Weight Scale, Food Scale
BIOLOGICAL	Blood draw	Per American Association of Clinical Endocrinology (AACE) guidelines

Timeline

• Start date: 2024-09-16
• Primary completion: 2026-03-01
• Completion: 2026-03-01
• First posted: 2024-11-14
• Last updated: 2025-11-19

Locations

1 site across 1 country: United States