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)

Novartis

Status and phase

Completed

Phase 4

Conditions

Renal Transplantation

Treatments

Drug: Enteric-Coated Mycophenolate Sodium (EC-MPS)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00154232

CERL080AAR01

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.