Study Comparing Cyclosporine Dose Reduction vs. Cyclosporine Elimination in Kidney Transplant Recipients Taking Sirolimus

Compare kidney function as measured by calculated creatinine clearance (using the method by Nankivell)1 at 12 months after transplantation in subjects receiving induction therapy with cyclosporine microemulsion (CsA) and Rapamune followed by CsA dose reduction (Group I) with subjects receiving induction therapy with CsA and Rapamune followed by CsA discontinuation (Group II).

Completed

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Key information

Conditions

Kidney Failure Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Graft vs Host Disease Immune System Diseases Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Curitiba, Paraná, Brazil

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Subjects with end-stage renal disease scheduled to receive a primary or secondary renal allograft from a cadaveric donor, from a living-unrelated donor, or a living-related HLA-mismatched donor. Subjects must be at least 18 years of age.

Exclusion criteria

Subjects with active major infection, including active hepatitis B or C infection, decreased platelets, elevated lipids, or multiple organ transplants.

Treatment and study plan

cyclosporine

Drug

Primary outcomes

Calculated creatinine clearance at 12 months post transplantation for patients on therapy.

Secondary outcomes

Calculated creatinine clearance at 6 months Serum creatinine at 6 and 12 months post-transplantation. Graft survival at 6 and 12 months post-transplantation. Incidence of biopsy confirmed acute graft rejections at 6 and 12 months post transplantation.

Sponsors and collaborators

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Industry

Registry information

Official study title

A Randomized, Open-label Study to Compare the Safety and Efficacy of Cyclosporine Dose Reduction With Cyclosporine Elimination in De Novo Renal Allograft Recipients Receiving Rapamune.

Important dates

Study start: 2004
Primary completion: 2006
Study completion: 2006
First posted: Sep 19, 2005
Registry last updated: Mar 8, 2011

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.

Published trials that share one or more normalized conditions with this study.

Completed