Immune Monitoring in Sensitized Patients at Risk of Rejection

Completed

• Conditions: Kidney Failure

• Registration Number: NCT03794817
• Lead Sponsor: University of California, San Francisco

Brief Summary

The purpose of this study is to test the effect of anti-rejection medications on your immune system

Detailed Description

Recipients of deceased or living donor transplants with calculated percent reactive antibody (cPRA) of 50% or greater at University of California, San Francisco (UCSF) will be enrolled in the trial. Samples for Kidney Solid Organ Response Test (kSORT) will be obtained pre-transplant (and immunosuppression) and post-transplant (see Table 1). Urine will be obtained at the same true intervals including pre-transplant in patients who still produce urine to correlate with graft rejection, inflammation and kSORT. A piece (minimum 1/3 core) of the protocol or for cause biopsy tissue will be saved in Ribonucleic acids (RNA) later for gene expression analysis as a correlate of graft inflammation with the biopsy, kSORT and urine. In addition, samples will be when patients are undergoing cause kidney biopsy, prior to treatment intensification and procedure. Patient's who are treated for rejection, will have additional samples obtained 2-4 weeks after treatment of rejection and at the time of any followup biopsy for monitoring resolution of biopsy confirmed acute rejection.

Study Timeline

• Study Start: 2015-08-20
• Primary Completion: 2017-09-08
• Study Completion: 2017-09-08
• Study First Submitted: 2018-12-12
• Status Verified: 2019-01
• Study First Submitted QC: 2019-01-03
• Last Update Submitted: 2019-01-03
• Study First Posted: 2019-01-07
• Last Update Posted: 2019-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

Inclusion Criteria

1. 18 years or older able to consent
2. No history of HIV, hepatitis C and active hepatitis B infection
3. cPRA ≥ 50%

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Exclusion Criteria

1. Patients on Coumadin
2. Human Leukocyte antigen (HLA) identical donor recipient patients

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Immune monitoring in sensitized patients at risk of rejection	2 years	Pretransplant Kidney Solid Organ Response Test (kSORT) predictive value of rejection in the first 6 months after transplantation

Secondary Outcome Measures

Name	Time	Method
Kidney Solid Organ Response Test (kSORT) with pathological findings	2 years	Correlation of kSORT with pathological findings on kidney biopsy

Trial Locations

Locations (1)

University of California San Francisco; 🇺🇸 San Francisco, California, United States