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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
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 August 30, 2015
Delayed Graft Function
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs