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Testing Immunosuppression Threshold in Renal Allografts To Extend eGFR

NCT02581436 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2018-03-06

No results posted yet for this study

Summary

This study evaluates the addition of "Kidney Solid Organ Rejection Test" (kSORT), in the clinical follow-up of renal transplant recipients, compared to clinical standard surveillance in the first two years after kidney transplantation. The design of the study is a partially blinded, randomized control trial of patients with living and deceased donor. The recruitment will be in a third level attention hospital in Mexico city (Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán). The main outcomes are the rate and grade of acute rejection, histologic chronic index of the one year protocol biopsy and glomerular filtration rate.

Conditions

  • Disorder Related to Renal Transplantation
  • Renal Transplant Rejection
  • Acute Graft Rejection

Interventions

OTHER

kSORT assay based follow-up

kSORT assay in pre-established days: 14, 45, 90, 180, 365 and 540 of post transplantation follow-up. If kSORT result is positive maintenance immunosuppressive will be increased (tacrolimus trough levels 12-15 ng/mL, Mofetil Mycophenolate 1.5 mg every 24 hours and prednisone 5 mg/day) and graft biopsy will be obtained. Kidney biopsy will be obtained one mo after treatment as well as kSORT assay. If kSORT result is negative, the maintenance immunosuppressor dosages will remain as established in our institutional guidelines. If after a year of follow-up, the kSORT result is negative, immunosuppression will be decreased (Tacrolimus levels 5 - 10 ng/ml and mofetil mycophenolate 500 mg every 12 hours).

OTHER

Standard follow-up

Surveillance will be the usual, includes creatinine determinations and clinical evaluation as often as established in the institutional protocol. A kidney graft biopsy will be obtained in case of dysfunction (increase in serum creatinine \>25% above baseline or 0.3 mg/mL above baseline) or as part of our institutional programmed biopsies (months 3 and 12). Treatment will be established in accordance with biopsy results. In all cases of rejection a kidney biopsy will be obtained one month after initiating treatment. In this control group, samples for kSORT analysis will be collected on pre-established dates for the study, but patient treatment will not be contingent on the assay's results; investigators will be blinded to the result in this control patient group.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2018-02-01
Completion
2018-02-01

Countries

  • Mexico

Study Locations

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Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02581436 on ClinicalTrials.gov