Immunosuppression Reduction in Failed Allograft Guided by cfDNA

• Sponsor: University of Minnesota (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT04560582
• Collaborator: (none)
• Enrollment: 30
• Anticipated Duration (Months): 13

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Kidney Transplant; Complications; Kidney Transplant Rejection; Kidney Transplant Failure	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 Design

• Study Type: Observational
• Anticipated Enrollment: 30 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Immunosuppression Reduction in Failed Allograft Guided by cfDNA
• Anticipated Study Start Date: Aug 31, 2022
• Anticipated Primary Completion Date: Sep 1, 2023
• Anticipated Study Completion Date: Oct 1, 2023

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. cPRA Concentrations [1 day]

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

2. cf-DNA Concentrations [up to 24 weeks]

   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.

Secondary Outcome Measures

1. Incidence of Need for Transfusion [24 weeks]

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

2. Incidence of Need for Methylprednisolone and Allograft Nephrectomy [24 weeks]

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

3. Incidence of ESA Dose [24 weeks]

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

4. Incidence of Allograft Tenderness [24 weeks]

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

5. Incidence of Gross Hematuria [24 weeks]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Failed allograft requiring dialysis

• Urine output less than 500 cc/day

• No living donor available for re-transplant option or anticipated deceased donor within the next 12 months

Exclusion Criteria:

• cPRA at entrance of 100%

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• University of Minnesota

Investigators

• Principal Investigator: Adam Bregman, MD, University of Minenesota

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Minnesota
• ClinicalTrials.gov Identifier: NCT04560582
• Other Study ID Numbers: NEPH-2018-27080
• First Posted: Sep 23, 2020
• Last Update Posted: Jul 14, 2022
• Last Verified: Jul 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jul 14, 2022