Immunosuppression Reduction in Failed Allograft Guided by cfDNA

Withdrawn

• Conditions: Kidney Transplant Failure; Kidney Transplant; Complications; Kidney Transplant Rejection
• Interventions: Procedure: Blood Draw

• Registration Number: NCT04560582
• Lead Sponsor: University of Minnesota

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-09-17
• Study First Submitted QC: 2020-09-17
• Study First Posted: 2020-09-23
• Study Start: 2022-09-22
• Primary Completion: 2023-09
• Study Completion: 2023-10
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-26
• Last Update Posted: 2023-11-29

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
cPRA Concentrations	1 day	Outcome is reported as the serum concentration of calculated Panel Reactive Antibody (cPRA) at baseline.
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

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

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States