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Comparison of CNI-based Regimen Versus CNI-free Regimen in Kidney Transplant Recipients.

NCT00332839 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 93

Last updated 2014-08-28

Study results available
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Summary

Calcineurin inhibitors (CNI), a potent immunosuppressive drug used in kidney transplant recipients to prevent graft rejection, may cause renal impairment. The aim of this study is to assess whether a CNI-free regimen with enteric-coated mycophenolate sodium and everolimus is as safe and well tolerated as a standard regimen consisting of enteric-coated mycophenolate sodium and cyclosporine microemulsion without a compromise in therapeutic efficacy while resulting in an improved renal function.

Conditions

  • Renal Transplantation

Interventions

DRUG

Everolimus

Participants, switching from the CsA based treatment, initially received everolimus 1.5 mg/day and then from day 7, 3 mg/day, and then from day 14, the dose was based on the participants' blood level (6-10 ng/ml). Participants, switching from the tacrolimus based treatment, initially received 3 mg/day and then from day 14, the dose was based on the participants' blood level (6-10 ng/ml).

DRUG

Cyclosporin A (CsA)

The dose was based on the participants' blood level of C0h (80-150 ng/ml).

DRUG

Tacrolimus

The dose was based on the participants' blood level of C0h (5-10 ng/ml).

DRUG

Enteric Coated - Mycophenolate Sodium (EC-MPS)

The dose was ≥ 720 mg/day.

DRUG

Corticosteroids

Corticosteroids were given according to local standard and/or the Investigators' discretion.

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

  • Novartis · Novartis

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-11-30
Primary Completion
2013-03-31
Completion
2013-03-31

Countries

  • Germany

Study Locations

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Entities

Drugs
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 NCT00332839 on ClinicalTrials.gov