Immunosuppression Reduction in Failed Allograft Guided by cfDNA

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.

Study Overview

• Status: Withdrawn
• Conditions: Kidney Transplant Rejection; Kidney Transplant; Complications; Kidney Transplant Failure
• Intervention / Treatment: Procedure: Blood Draw

Detailed 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.

• Study Type: Observational

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

This study proposes to recruit adult patients primarily from the inpatient units at UMMC Fairview, or the Renal or Transplant facilities at the Clinics and Surgery Center as attended by the PI and Co-Is. Additional clinics will be recruited from depending on patient population and clinician support.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Kidney Transplant Patients with Failed Allograft; All participants are assigned to a single cohort of kidney transplant patients with failed allograft requiring dialysis.	Procedure: Blood Draw; Participants will have blood drawn for analysis at baseline and every 4 weeks for a total of 7 blood draws over 24 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cPRA Concentrations	Outcome is reported as the serum concentration of calculated Panel Reactive Antibody (cPRA) at baseline.	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.	up to 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Need for Transfusion	Outcome is reported as the percent of participants who require transfusion.	24 weeks
Incidence of Need for Methylprednisolone and Allograft Nephrectomy	Outcome is reported as the percent of participants who require methylprednisolone and allograft nephrectomy	24 weeks
Incidence of ESA Dose	Outcome is reported as the percent of participants who require a erythropoesis stimulating agent (ESA) dose.	24 weeks
Incidence of Allograft Tenderness	Outcome is reported as the percent of participants who experience allograft tenderness.	24 weeks
Incidence of Gross Hematuria	Outcome is reported as the percent of participants who experience gross hematuria.	24 weeks

Collaborators and Investigators

• Sponsor: University of Minnesota
• Investigators: Principal Investigator: Adam Bregman, MD, University of Minenesota

Study record dates

Study Major Dates

• Study Start (Actual): September 22, 2022
• Primary Completion (Estimated): September 1, 2023
• Study Completion (Estimated): October 1, 2023

Study Registration Dates

• First Submitted: September 17, 2020
• First Submitted That Met QC Criteria: September 17, 2020
• First Posted (Actual): September 23, 2020

Study Record Updates

• Last Update Posted (Actual): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 26, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: NEPH-2018-27080

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No