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Immunosuppression Reduction in Failed Allograft Guided by cfDNA

University of Minnesota (UMN) logo

University of Minnesota (UMN)

Status

Withdrawn

Conditions

Kidney Transplant Failure
Kidney Transplant; Complications
Kidney Transplant Rejection

Treatments

Procedure: Blood Draw

Study type

Observational

Funder types

Other

Identifiers

NCT04560582
NEPH-2018-27080

Details and patient eligibility

About

The optimal timing for immunosuppression tapering for patients with failed kidney transplant is not known. This pilot study would be to correlate rise in cf-DNA and increase in cPRA.

Full description

This is an observational cohort study collecting data and blood specimens at designated time points. The primary outcome will be comparing the cPRA in patients that have a rise in cf-DNA to those that do not have a rise in cf-DNA. Seondary outcomes include comparison of the combined incidence of need for transfusion, need for methylprednisolone and allograft nephrectomy, ESA dose, allograft tenderness, and gross hematuria.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Failed allograft requiring dialysis
  • No living donor available for re-transplant option or anticipated deceased donor within the next 12 months
  • Patient to be enrolled prior to 3rd HD (hemodialysis) session or within 1 week of starting peritoneal dialysis

Exclusion criteria

  • 17 years or younger
  • cPRA at entrance of 100%
  • Primary non-function of the allograft
  • Multi-organ transplant

Trial design

0 participants in 1 patient group

Kidney Transplant Patients with Failed Allograft
Description:
All participants are assigned to a single cohort of kidney transplant patients with failed allograft requiring dialysis.
Treatment:
Procedure: Blood Draw

Trial contacts and locations

1

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Central trial contact

Ghislaine Feussom; Adam Bregman, MD

Data sourced from clinicaltrials.gov

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