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)
This study has been completed.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
First received: September 7, 2005
Last updated: November 1, 2011
Last verified: November 2011
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.
Drug: Enteric-Coated Mycophenolate Sodium (EC-MPS)
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
||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.
Primary Outcome Measures:
- Incidence of first episodes of BPAR at month 3 post transplant
Secondary Outcome Measures:
- 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
| Estimated Enrollment:
| Study Start Date:
| Primary Completion Date:
||March 2005 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||18 Years to 70 Years
|Genders Eligible for Study:
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00154232
No publications provided
||Novartis ( Novartis Pharmaceuticals )
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 7, 2005
||November 1, 2011
||Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Keywords provided by Novartis:
Renal transplantation, DGF, basiliximab, EC-MPS, cyclosporine
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 06, 2014
Delayed Graft Function
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs