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Efficacy and Safety of Everolimus+EC-MPS After Early CNI Elimination vs EC-MPS +Tacrolimus in Renal Transplant Recipients

NCT00965094 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2014-08-15

Study results available
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Summary

The primary objective of this trial is to show non-inferiority of a CNI-free regimen with respect to the renal function at Month 9 post Tx assessed by glomerular filtration rate - Nankivell method - as compared to the standard CNI-based regimen in de novo renal transplant patients.

Conditions

  • Chronic Renal Failure

Interventions

DRUG

Everolimus

One tablet containing 0.25, 0.5mg or 0.75 mg. Initially 2 mg/day. Afterwards based on blood level (target 6-10 ng/mL)

DRUG

Tacrolimus (FK506)

Capsules 0.5 mg, 1 mg. Dosing according to blood level.

DRUG

Basiliximab

One vial containing 20 mg lyophilisate. 2 x 20 mg \[day 0 (2 hrs prior to Tx) and day 4 post Tx\] to be applied as 10 sec. bolus injection, i.v.

DRUG

Enteric Coated Mycophenolate Sodium (EC-MPS)

One tablet containing 180 mg or 360 mg. 1440 mg/day (2x720 mg). If tolerated, dose reduction due to side effectis were possible (min. dose at BL@: 720 mg/day)

DRUG

Corticosteroids

Used according to Israeli standards. A minimum dose of 5mg \[prednisone, or equivalent, was used throughout the study period.

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2013-06-30
Completion
2013-06-30

Countries

  • Israel

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 NCT00965094 on ClinicalTrials.gov