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Study Comparing Standard Dose and Reduced Dose Tacrolimus With Sirolimus in Renal Transplant Patients

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00519116
First received: July 27, 2007
Last updated: August 20, 2007
Last verified: August 2007

July 27, 2007
August 20, 2007
October 2000
Not Provided
Calculated creatinine clearance at month 6 post transplantation [ Time Frame: 6 months ]
Same as current
Complete list of historical versions of study NCT00519116 on ClinicalTrials.gov Archive Site
Patient and graft survival at 6 months post transplantation; the safety of sirolimus + corticosteroids given concomitantly with reduced or standard dose tacrolimus [ Time Frame: 6 months ]
Same as current
Not Provided
Not Provided
 
Study Comparing Standard Dose and Reduced Dose Tacrolimus With Sirolimus in Renal Transplant Patients
An Open-Label, Concentration-Controlled, Randomized, 6-Month Study of 'Standard Dose' Tacrolimus + Sirolimus + Corticosteroids Compared to 'Reduced-Dose' Tacrolimus + Sirolimus + Corticosteroids in Renal Allograft Recipients

The study evaluated renal graft function (based on the calculated creatinine clearance) 6 months after kidney transplantation in patients receiving either a regimen of 'reduced-dose' tacrolimus + sirolimus + corticosteroids or a regimen of 'standard-dose' tacrolimus + sirolimus + corticosteroids.

The study evaluated renal graft function (based on the calculated creatinine clearance) 6 months after kidney transplantation in patients receiving either a regimen of 'reduced-dose' tacrolimus + sirolimus + corticosteroids or a regimen of 'standard-dose' tacrolimus + sirolimus + corticosteroids. The two treatment groups were also compared with respect to the incidence of acute graft rejection at 6 months and patient and graft survival at 6 months after transplantation.

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: Tacrolimus
  • Drug: Perioperative Corticosteroids
    The corticosteroids use was left up to the investigators decision.
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
150
August 2001
Not Provided

Inclusion criteria:

  • At least 18 years of age
  • End-stage renal disease in 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 a primary graft for at least 6 months

Exclusion criteria:

  • Planned antibody induction
  • Multiple organ transplants
  • History of malignancy within five years of enrollment
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00519116
0468E1-100539
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