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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
History of Changes

July 27, 2007
August 16, 2007
April 2000
Not Provided
Calculated creatinine clearance to evaluate renal function at 12 months post transplantation [ Time Frame: 12 months ]
Same as current
Complete list of historical versions of study NCT00518375 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Study Comparing Graft Function in Renal Allograft Recepients Receiving Reduced or Standard Dose CsA With Sirolimus
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

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.

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.
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Kidney Transplantation
  • Drug: Rapamune® (Sirolimus)
  • Drug: Neoral® (Cyclosporine)
  • Drug: Corticosteroids
    Left up to local practice but steroids are typically used perioperatively
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
250
May 2001
Not Provided

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
Both
18 Months and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00518375
0468E1-100154
Not Provided
Not Provided
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
August 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP