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

NCT ID: NCT06688825

Last Updated: 2025-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-16

Study Completion Date

2026-03-31

Brief Summary

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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

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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

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Kidney Transplant; Complications Obesity

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

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.

Study Groups

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Subjects on the waiting list for kidney transplant at VCUHS with BMI greater than 35 kg/m2.

This project will be a single-arm feasibility study, with a treatment intervention that includes three interrelated components: (1) the use of medications for weight loss, (2) patient education using a proven weight loss curriculum, and (3) technology tools for making healthy lifestyle choices.

Group Type EXPERIMENTAL

Education regarding Weight loss

Intervention Type BEHAVIORAL

Per American Association of Clinical Endocrinology (AACE) guidelines

Lifestyle tools for weight loss

Intervention Type BEHAVIORAL

Calorie App, Continuous GlucosWe Monitor (CGM), Weight Scale, Food Scale

Blood draw

Intervention Type BIOLOGICAL

Per American Association of Clinical Endocrinology (AACE) guidelines

Interventions

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Education regarding Weight loss

Per American Association of Clinical Endocrinology (AACE) guidelines

Intervention Type BEHAVIORAL

Lifestyle tools for weight loss

Calorie App, Continuous GlucosWe Monitor (CGM), Weight Scale, Food Scale

Intervention Type BEHAVIORAL

Blood draw

Per American Association of Clinical Endocrinology (AACE) guidelines

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* on the waiting list for kidney transplant at VCUHS
* BMI greater than 35 kg/m2

Exclusion Criteria

* Children, prisoners, pregnant women
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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American Society of Health-System Pharmacists Research and Education Foundation

OTHER

Sponsor Role collaborator

Virginia Commonwealth University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Evan Sisson

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

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Virginia Commonwealth University

Richmond, Virginia, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Evan Sisson

Role: CONTACT

804-828-8076

Dana Burns

Role: CONTACT

804-828-5180

Facility Contacts

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Evan Sisson

Role: primary

804-828-8076

Dana Burns

Role: backup

804-828-5180

Other Identifiers

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HM20029799

Identifier Type: -

Identifier Source: org_study_id

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