MedTrace Logo

Calcineurin Free Immunosuppression in Renal Transplant Recipients

NCT00812123 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 127

Last updated 2008-12-19

No results posted yet for this study

Summary

The main purpose of this study is to obtain preliminary information on the efficacy, safety and cost of two regimens, Rapamycin / MMF / steroid therapy and Cyclosporine A Neoral / MMF / steroid therapy, used in the prevention of acute rejection following renal transplantation.

Conditions

Interventions

DRUG

Sirolimus

Loading dose 30 mg for three days, trough level of 10-20 ng/ml month 1-3, 8-15 ng/ml month 4 - 6

DRUG

Cyclosporine A

Loading dose of 300 mg for three days, trough levels 250-300 ng/ml months 1-3, 150-250 ng/ml months 4 to 6

DRUG

Prednisone

0.5 mg/kg, tapering every two weeks until 0.1 mg/kg

DRUG

Mycophenolate mofetil

2 x 1000mg, through level above 2ug/ml

PROCEDURE

Protocol biopsies

protocol kidney biopsies at month one and three

Sponsors & Collaborators

  • Wyeth is now a wholly owned subsidiary of Pfizer

    collaborator INDUSTRY

  • University Hospital, Basel, Switzerland

    lead OTHER

Principal Investigators

  • Jürg U Steiger, MD · Clinic for Transplantation Immunology and Nephrology, University Hospital, Basel, Switzerland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-01-31
Primary Completion
2005-07-31
Completion
2005-07-31

Countries

  • Switzerland

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT00812123 on ClinicalTrials.gov