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.
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00154232
First received: September 7, 2005
Last updated: November 1, 2011
Last verified: November 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Renal Transplantation |
Drug: Enteric-Coated Mycophenolate Sodium (EC-MPS) |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | 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. |
Resource links provided by NLM:
MedlinePlus related topics:
Kidney Transplantation
Drug Information available for:
Mycophenolic acid
Mycophenolate sodium
Cyclosporine
Mycophenolate mofetil hydrochloride
Mycophenolate mofetil
Basiliximab
U.S. FDA Resources
Further study details as provided by Novartis:
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: | 46 |
| Study Start Date: | June 2004 |
| Primary Completion Date: | March 2005 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
Criteria
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.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Novartis ( Novartis Pharmaceuticals ) |
| ClinicalTrials.gov Identifier: | NCT00154232 History of Changes |
| Other Study ID Numbers: | CERL080AAR01 |
| Study First Received: | September 7, 2005 |
| Last Updated: | November 1, 2011 |
| Health Authority: | Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica |
Keywords provided by Novartis:
|
Renal transplantation, DGF, basiliximab, EC-MPS, cyclosporine |
Additional relevant MeSH terms:
|
Delayed Graft Function Pathologic Processes Cyclosporins Cyclosporine Mycophenolic Acid Mycophenolate mofetil Basiliximab Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antifungal Agents Anti-Infective Agents Therapeutic Uses Dermatologic Agents Antirheumatic Agents Antibiotics, Antineoplastic Antineoplastic Agents |
ClinicalTrials.gov processed this record on May 19, 2013