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)

November 1, 2011 updated by: Novartis Pharmaceuticals

A 3 Month, Multicenter, Open-label Study to Evaluate the Impact of the Immunosuppressive Combination of Enteric-Coated Mycophenolate Sodium (EC- MPS), Basiliximab and Cyclosporine for Microemulsion With C2 Monitoring, on Efficacy and Safety Outcomes in de Novo Kidney Transplant Recipients at Potential High Risk of DGF.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

46

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Incidence of first episodes of BPAR at month 3 post transplant

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2004

Primary Completion (Actual)

March 1, 2005

Study Registration Dates

First Submitted

September 7, 2005

First Submitted That Met QC Criteria

September 7, 2005

First Posted (Estimate)

September 12, 2005

Study Record Updates

Last Update Posted (Estimate)

November 2, 2011

Last Update Submitted That Met QC Criteria

November 1, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CERL080AAR01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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