CompletedNot Applicable

Eliminating the Need for Pancreas Biopsy Using Peripheral Blood Cell-free DNA

United States140 participantsStarted 2019-09-01

Plain-language summary

Donor-derived cell-free DNA (dd-cfDNA) has shown promise as an early marker for cellular injury caused by rejection. dd-cfDNA changes may also indicate other injuries that lead to progressive decline in transplant organ function associated with, in the case of kidney transplantation, the presence of interstitial fibrosis (IF) and tubular atrophy (TA) seen in biopsy specimens. Here, we will study the utility of dd-cfDNA to predict rejection in pancreas and pancreas-kidney recipients.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Adult recipients (Age \> 18 years )
✓. All genders and all racial and ethnic groups
✓. Pancreas transplant alone (PTA)
✓. Simultaneous kidney-pancreas transplantation (SPK)
✓. Pancreas-after-kidney (PAK) 6. Simultaneous pancreas and living donor kidney (SPLK)

Exclusion criteria

✕. Pediatric recipients (Age \< 18 years)
✕. Pregnant women
✕. Patients undergoing multi-organ transplants not otherwise specified (e.g., pancreas-liver, multi-visceral, or pancreas-heart)
✕. Patients receiving donor kidney from an identical twin, as part of an SPLK (see above)
✕. Did not provide consent

What they're measuring

dd-cfDNA correlation to acute rejection

Timeframe: August 1, 2019 to July 31, 2022

Trial details

NCT IDNCT04166149

SponsorUniversity of Maryland, Baltimore

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-07-30

View on ClinicalTrials.gov More Transplant;Failure,Kidney trials