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NCT00519116 Clinical Trial

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

Kidney Transplantation Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00519116
Other study ID # 0468E1-100539
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date October 2000
Est. completion date August 2001

Study information
Verified date December 2023
Source Wyeth is now a wholly owned subsidiary of Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility
Status Completed
Enrollment 150
Est. completion date August 2001
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Rapamune® (Sirolimus)

• Tacrolimus

• Perioperative Corticosteroids
The corticosteroids use was left up to the investigators decision.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Outcome
Type Measure Description Time frame Safety issue
Primary Calculated creatinine clearance at month 6 post transplantation 6 months
Secondary Patient and graft survival at 6 months post transplantation; the safety of sirolimus + corticosteroids given concomitantly with reduced or standard dose tacrolimus 6 months
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