Immunosuppression Reduction in Failed Allograft Guided by cfDNA

University of Minnesota

Overview

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.

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.

Study Type

OBSERVATIONAL

Conditions

Kidney Transplant; Complications Kidney Transplant Rejection Kidney Transplant Failure

Interventions

Blood DrawPROCEDURE

Participants will have blood drawn for analysis at baseline and every 4 weeks for a total of 7 blood draws over 24 weeks.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Minnesota

Minneapolis, Minnesota, United States

Outcomes

Primary Outcomes

cPRA Concentrations

Outcome is reported as the serum concentration of calculated Panel Reactive Antibody (cPRA) at baseline.

Time frame: 1 day

cf-DNA Concentrations

Outcome is reported as the serum concentration of circulating-free DNA (cfDNA) at baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, and 24 weeks.

Time frame: up to 24 weeks

Secondary Outcomes

Incidence of Need for Transfusion

Outcome is reported as the percent of participants who require transfusion.

Time frame: 24 weeks

Incidence of Need for Methylprednisolone and Allograft Nephrectomy

Outcome is reported as the percent of participants who require methylprednisolone and allograft nephrectomy

Time frame: 24 weeks

Incidence of ESA Dose

Outcome is reported as the percent of participants who require a erythropoesis stimulating agent (ESA) dose.

Time frame: 24 weeks

Incidence of Allograft Tenderness

Outcome is reported as the percent of participants who experience allograft tenderness.

Time frame: 24 weeks

Incidence of Gross Hematuria

Outcome is reported as the percent of participants who experience gross hematuria.

Time frame: 24 weeks

Data from ClinicalTrials.gov

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