Trials / Completed
CompletedNCT00519116
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
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 150 (planned)
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Rapamune® (Sirolimus) | |
| DRUG | Tacrolimus | |
| DRUG | Perioperative Corticosteroids | The corticosteroids use was left up to the investigators decision. |
Timeline
- Start date
- 2000-10-01
- Completion
- 2001-08-01
- First posted
- 2007-08-21
- Last updated
- 2023-12-11
Source: ClinicalTrials.gov record NCT00519116. Inclusion in this directory is not an endorsement.