Study Comparing Graft Function in Renal Allograft Recepients Receiving Reduced or Standard Dose CsA With Sirolimus

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00518375

Enrollment

250

Registered

2007-08-20

Start date

2000-04-30

Completion date

2001-05-31

Last updated

2023-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Transplantation

Brief summary

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.

Detailed description

This study evaluated renal graft function (based on calcuated creatinine clearance) 12 months after kidney transplantation in patients receiving either a regimen of reduced dose or standard dose cyclosporine (CsA) 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 after transplantation were evaluated also.

Interventions

DRUGRapamune® (Sirolimus)

DRUGNeoral® (Cyclosporine)

DRUGCorticosteroids

Left up to local practice but steroids are typically used perioperatively

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Months to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Incidence of acute graft rejection at 6 and 12 months post transplantation and patient and graft survival at 12 months post transplantation	12 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026