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OpenTrials
Completed

NCT Number: NCT00257387

Study Evaluating Cyclosporine Dose Reduction and Cyclosporine Elimination in Chinese Kidney Transplants

Evaluate the incidence of acute rejection at 12 months after transplantation in subjects receiving induction therapy with cyclosporine microemulsion (CsA) and Rapamune followed by CsA dose reduction (Phase I) with subjects receiving induction therapy with CsA and Rapamune followed by CsA discontinuation (Phase II) in Chinese de novo renal allograft recipients.

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Key information

Conditions

Kidney Transplant

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

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 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, HIV, decreased platelets, elevated lipids, or multiple organ transplants.

Treatment and study plan

cyclosporine

Drug

Primary outcomes

  1. The incidence and severity of acute rejection in renal allograft recipients at 6 months post-transplantation.

Secondary outcomes

  1. To evaluate the treatment groups with respect to incidence of adverse events, renal function, subject and graft survival at 6 and 12 months, and the incidence and severity of acute rejection at 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 Nonrandomized, Open-label, Multicenter, Sequential Phase Study to Evaluate the Safety and Efficacy of Cyclosporine Dose Reduction and Cyclosporine Elimination in Chinese De Novo Renal Allograft Recipients Receiving Rapamune

Important dates

Study start
2004
Study completion
2006
First posted
Nov 22, 2005
Registry last updated
Feb 2, 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.

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