Clinical trial

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

NCT00519116

Name

0468E1-100539

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.

Trial arms

Trial start

2000-10-01

Trial end

2001-08-01

Status

Completed

Phase

Early phase I

Treatment

Rapamune® (Sirolimus)

Tacrolimus

Perioperative Corticosteroids

The corticosteroids use was left up to the investigators decision.

Size

150

Primary endpoint

Calculated creatinine clearance at month 6 post transplantation

6 months

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 150}}

Updated at

2023-12-11

1 organization

3 products

1 indication

Product

Perioperative Corticosteroids

Indication

Organization

Product

Product