Study Comparing Graft Function in Renal Allograft Recepients Receiving Reduced or Standard Dose CsA With Sirolimus

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00518375
First received: July 27, 2007
Last updated: August 16, 2007
Last verified: August 2007
  Purpose

This study evaluated renal graft function (based on calcuated creatinine clearance) 12 months after transplantation in patients receiving either a regimen of reduced dose or standard dose cyclosporine in combination with sirolimus and corticosteroids. The incidence of acute graft rejection at 6 and 12 months following transplantation and patient and graft survival at 12 months were evaluated also.


Condition Intervention Phase
Kidney Transplantation
Drug: Rapamune® (Sirolimus)
Drug: Neoral® (Cyclosporine)
Drug: Corticosteroids
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Comparative, Open-Label Study to Evaluate Graft Function in de Novo Renal Allograft Recipients Treated With Either a 'Reduced Dose' or a 'Standard Dose' of Cyclosporine in Combination With Sirolimus and Corticosteroids

Resource links provided by NLM:


Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • Calculated creatinine clearance to evaluate renal function at 12 months post transplantation [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • Incidence of acute graft rejection at 6 and 12 months post transplantation and patient and graft survival at 12 months post transplantation [ Time Frame: 12 months ]

Estimated Enrollment: 250
Study Start Date: April 2000
Estimated Study Completion Date: May 2001
Intervention Details:
    Drug: Rapamune® (Sirolimus) Drug: Neoral® (Cyclosporine) Drug: Corticosteroids
    Left up to local practice but steroids are typically used perioperatively
Detailed Description:

This study evaluated renal graft function (based on calcuated creatinine clearance) 12 months after kidney transplantation in patients receiving either a regimen of reduced dose or standard dose cyclosporine (CsA) in combination with sirolimus and corticosteroids. The incidence of acute graft rejection at 6 and 12 months following transplantation and patient and graft survival at 12 months after transplantation were evaluated also.

  Eligibility

Ages Eligible for Study:   18 Months and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults more than 18 years of age
  • End-stage renal disease, with patients receiving a primary or secondary renal allograft from a cadaveric, living-unrelated or living-related mismatched donor
  • Patients with a secondary transplant must have maintained their primary graft for at least 6 months

Exclusion Criteria:

  • Planned antibody induction therapy
  • Multiple organ transplants
  • Patients at a high risk of acute rejection
  Contacts and Locations
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: NCT00518375

Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00518375     History of Changes
Other Study ID Numbers: 0468E1-100154
Study First Received: July 27, 2007
Last Updated: August 16, 2007
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Cyclosporins
Cyclosporine
Sirolimus
Everolimus
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
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on July 26, 2014