Immune Monitoring in Sensitized Patients at Risk of Rejection

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03794817

Acronym

PRISM

Enrollment

112

Registered

2019-01-07

Start date

2015-08-20

Completion date

2017-09-08

Last updated

2019-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Failure

Keywords

Kidney transplant recipient

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Kidney Solid Organ Response Test (kSORT) with pathological findings	2 years	Correlation of kSORT with pathological findings on kidney biopsy

Countries

United States

Outcome results