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Immunosuppression Reduction in Failed Allograft Guided by cfDNA

NCT ID: NCT04560582

Last Updated: 2023-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2022-09-22

Study Completion Date

2023-10-31

Brief Summary

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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

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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.

Conditions

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Kidney Transplant; Complications Kidney Transplant Rejection Kidney Transplant Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Kidney Transplant Patients with Failed Allograft

All participants are assigned to a single cohort of kidney transplant patients with failed allograft requiring dialysis.

Blood Draw

Intervention Type PROCEDURE

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

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Minnesota

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Adam Bregman, MD

Role: PRINCIPAL_INVESTIGATOR

University of Minenesota

Locations

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University of Minnesota

Minneapolis, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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NEPH-2018-27080

Identifier Type: -

Identifier Source: org_study_id