Who is eligible for clinical trial NCT04953715?

Participants must meet protocol criteria for Kidney Transplant Rejection. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT04953715 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-08-04

Microbiome and Immunosuppression: The Mission Study (NCT04953715)

🔵 Active, Not Recruiting Interventional Protocol 📊 Observational Clinical Research Sponsor: The University of Texas Medical Branch, Galveston

🩺 Plain-English Summary (8th-Grade Level)

The purpose of this research is to study immunosuppression drugs, certain foods, and how they can change the microbiome (the natural microorganisms inside the body) of the individual taking the immunosuppressive medications. The study team wants to study how the microbiome affects how the body processes the transplant medication.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (6 items) and avoid the listed exclusions (11 items).

Location: University of Minnesota — Minneapolis, Minnesota

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Participants undergoing kidney transplant
Male or female at least 18 years of age at time of enrollment
Will or have received a living or deceased donor kidney transplant
Planned post-transplant immunosuppression regimen of mycophenolate mofetil dosed every 12 hours (Cellcept or generic) and immediate release tacrolimus dosed twice daily with trough concentration monitoring (generic or brand formulation).
Able and willing to complete study-related procedures and visits
Signs written informed consent

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
Recipient of a previous non-kidney transplant
Subject is a multi-organ transplant recipient
Presence of active gastroparesis, and documented in the medical record
Liver dysfunction (total bilirubin \>2x upper limit of normal) within 2 months of enrollment
Patients who take medications that significantly inhibit uridine 5'-diphosphate glucuronosyltransferase (UGT) enzymes.
Patients who take medications that significantly inhibit or induce the biliary transporters
Patient is known to be HIV positive
Pregnant or nursing (lactating) women
Non-English speaking
Patients who have undergone bariatric surgery

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (2 Sites)

University of Minnesota — Minneapolis, Minnesota
HCMC — Minneapolis, Minnesota

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗