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Completed

NCT Number: NCT00518375

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

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.

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Key information

Conditions

Kidney Transplantation

Age range

18 month and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rapamune® (Sirolimus)

Drug

Neoral® (Cyclosporine)

Drug

Corticosteroids

Drug

Left up to local practice but steroids are typically used perioperatively

Primary outcomes

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

    Time frame: 12 months

Secondary outcomes

  1. Incidence of acute graft rejection at 6 and 12 months post transplantation and patient and graft survival at 12 months post transplantation

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2000
Study completion
2001
First posted
Aug 20, 2007
Registry last updated
Dec 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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