Study to Evaluate the Combination of Enteric-coated Mycophenolate Sodium (EC-MPS), Basiliximab, and C2-monitored Cyclosporine in de Novo Renal Transplant Recipients at Potential High Risk of Delayed Graft Function (DGF)

Phase 4

Completed

• Conditions: Renal Transplantation

• Registration Number: NCT00154232
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

The aim of the study is to assess the short-term benefit of the combination of basiliximab, EC-MPS and cyclosporine microemulsion with C2 monitoring on the prophylaxis of acute rejection in a population of de novo renal transplant patients at potential high risk of DGF.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-06
• Primary Completion: 2005-03
• Study First Submitted: 2005-09-07
• Study First Submitted QC: 2005-09-07
• Study First Posted: 2005-09-12
• Status Verified: 2011-11
• Last Update Submitted: 2011-11-01
• Last Update Posted: 2011-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

• Age 18-70 years old

• Patients receiving a primary or secondary cadaveric or living donor kidney
• Patients who have given written informed consent for study participation
• Females capable of becoming pregnant must have a negative pregnancy test at baseline and are required to practice birth control for the duration of the study and at least for four months following the last dose of basiliximab.

Exclusion Criteria

• Recipient of multi-organ transplants or previously transplanted organs other than kidney
• Recipient of dual kidney transplants
• Recipient of a transplanted kidney from a Non-Heart Beating Donor (NHBD)
• Recipient of a HLA identical living-donor kidney
• Patients with a PRA level (past or current level) greater than 20%
• Patients anticipated by investigators to require induction therapy with OKT3, ATGAM, or Thymoglobulin for any reason
• Patients with any medical condition which, in the opinion of the investigator, would preclude the patient from participating in the study
• Cold ischemia time larger than 36 hours.
• Patients who have received an investigational drug or therapy within one month prior to study entry or if such therapy is to be instituted post-transplantation.
• Female transplant candidates who are pregnant, lactating, or of childbearing potential and not willing to practice an acceptable method of contraception
• Patients with a known hypersensitivity to cyclosporine
• Patients with a known malignancy or a history of malignancy, other than successfully treated non-metastatic basal or squamous cell carcinoma of the skin
• Known HIV positive antibody status
• Evidence of any clinically relevant (per investigator determination) active infection
• Patients unable to participate in the study for the full 3-month study period
• Other protocol-defined exclusion criteria may apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Incidence of first episodes of BPAR at month 3 post transplant

Secondary Outcome Measures

Name	Time	Method
when the patient begins dialysis treatments without
The time of graft failure will be defined as the time of start of dialysis, or time of nephrectomy, whatever occurs first.
Incidence of graft loss or, synonymously, graft failure)
The allograft will defined as lost (or: to have failed)
subsequent graft recovery.
Incidence of patients death at month 3 post transplant.
Number of myfortic dose adjustments/discontinuations