Immune Monitoring in Sensitized Patients at Risk of Rejection (PRISM)

• ClinicalTrials.gov Identifier: NCT03794817
• Recruitment Status: Completed
• First Posted: January 7, 2019
• Last Update Posted: January 7, 2019
• Sponsor: University of California, San Francisco
• Information provided by (Responsible Party): University of California, San Francisco

Study Description

Brief Summary:

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

Condition or disease
Kidney Failure

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 Design

• Study Type: Observational
• Actual Enrollment: 112 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Immune Monitoring in Sensitized Patients at Risk of Rejection
• Actual Study Start Date: August 20, 2015
• Actual Primary Completion Date: September 8, 2017
• Actual Study Completion Date: September 8, 2017

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. Immune monitoring in sensitized patients at risk of rejection [ Time Frame: 2 years ]
   Pretransplant Kidney Solid Organ Response Test (kSORT) predictive value of rejection in the first 6 months after transplantation

Secondary Outcome Measures :

1. Kidney Solid Organ Response Test (kSORT) with pathological findings [ Time Frame: 2 years ]
   Correlation of kSORT with pathological findings on kidney biopsy

Biospecimen Retention:   Samples Without DNA

Blood and urine

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Patients who have received a kidney transplant and will be taking immunosuppressive medications.

Criteria

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%

Exclusion Criteria:

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

Contacts and Locations

Locations

United States, California

University of California San Francisco

San Francisco, California, United States, 94143

Sponsors and Collaborators

University of California, San Francisco

Investigators

• Principal Investigator: Flavio Vincenti, M.D.; University of California, San Francisco

More Information

• Responsible Party: University of California, San Francisco
• ClinicalTrials.gov Identifier: NCT03794817
• Other Study ID Numbers: PRISM
• First Posted: January 7, 2019
• Last Update Posted: January 7, 2019
• Last Verified: January 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

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

Keywords provided by University of California, San Francisco:

Kidney transplant recipient

Additional relevant MeSH terms:

Renal Insufficiency; Kidney Diseases; Urologic Diseases