Immunosuppression Reduction in Failed Allograft Guided by cfDNA

NCT04560582 | Withdrawn

• 1 other identifier: NEPH-2018-27080
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Transplant; Complications; Kidney Transplant Rejection; Kidney Transplant Failure

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Incidence of Need for Transfusion

  24 weeks

• Incidence of Need for Methylprednisolone and Allograft Nephrectomy

  24 weeks

• Incidence of ESA Dose

  24 weeks

• Incidence of Allograft Tenderness

  24 weeks

• Incidence of Gross Hematuria

  24 weeks

Study Arms (1)

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

Interventions

Blood Draw PROCEDURE

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

Kidney Transplant Patients with Failed Allograft

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Specimens will be stored by study code. All study data will be associated with the specimen through the study code link.

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Adam Bregman, MD

  University of Minenesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2020
• First Posted: September 23, 2020
• Study Start: September 22, 2022
• Primary Completion: September 1, 2023
• Study Completion: October 1, 2023
• Last Updated: November 29, 2023

Record last verified: 2023-11

Locations

US (1)