Clinical trial

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

Name

0468E1-100154

Description

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.

Trial arms

Trial start

2000-04-01

Trial end

2001-05-01

Status

Completed

Phase

Early phase I

Treatment

Rapamune® (Sirolimus)

Neoral® (Cyclosporine)

Corticosteroids

Left up to local practice but steroids are typically used perioperatively

Size

250

Primary endpoint

Calculated creatinine clearance to evaluate renal function at 12 months post transplantation

12 months

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 250}}

Updated at

2023-12-11

1 organization

3 products

1 indication

Organization

Product

Indication

Product

Product