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

NCT00443508 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2007-03-06

No results posted yet for this study

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.

Conditions

Interventions

DRUG

adding Certican to therapy

DRUG

reducing Tacrolimus

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • Rabin Medical Center

    lead OTHER

Principal Investigators

  • Eytan Mor, Prof · Rabin Medical Center, head of Transplantation department

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-02-28
Completion
2010-02-28

Countries

  • Israel

Study Locations

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Diseases
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 NCT00443508 on ClinicalTrials.gov