drugset / Trial / NCT00443508

Reduction or Discontinuation of CNI's With Conversion to Everolimus-Based Immunosuppresion

NCT00443508

Phase 4 Unknown 60 enrolled Rabin Medical Center Novartis · collab
RandomizedParallel-groupOpen-labelTreatment

Summary

This study is design to compare two different strategies aiming to lessen the degree of the ongoing process of allograft injury either by removing tacrolimus from the maintenance immunosuppressive protocol or by reducing tacrolimus dose. The primary goal is to assess the change in renal function at 6 and 12 months after conversion using creatinine levels and calculated creatinine clearance. The study will include two groups: The study group of 30 patients and a matched control group with creatinine levels at similar range.

Timeline

Start
2007-02
Primary completion
Completion
2010-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Everolimus Small molecule
Subject Tacrolimus Small molecule

Indications