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OpenTrials
Completed

NCT Number: NCT00099749

Safety and Efficacy of FTY720 in Adult Patients Who Receive a Kidney Transplant

The efficacy and safety of FTY720 is being evaluated in patients who receive a kidney transplant.

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Key information

Conditions

Kidney Transplantation Behavior Rejection, Psychology Social Behavior

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Loyola University Medical Center, Maywood, Illinois, United States

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Who can participate

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

Inclusion criteria

  • Male and Female
  • Between 18 to 65 years old

Exclusion criteria

  • Patients in need of multiple organ transplants

Treatment and study plan

FTY 720

Drug

Primary outcomes

  1. Biopsy-proven acute rejection (BPAR), graft loss, death and study discontinuation, within 6 months post transplantation.

Secondary outcomes

  1. Safety/tolerability based on adverse event reporting.

  2. BPAR, graft loss, death and study discontinuation, within 6 and 12 months post transplantation.

  3. Efficacy parameters between the 3 treatment groups within 6 and 12 months post-transplantation.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Important dates

Study start
2003
Primary completion
2006
First posted
Dec 20, 2004
Registry last updated
Feb 23, 2017

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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