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Completed

NCT Number: NCT00239902

Efficacy and Safety of FTY720 in de Novo Adult Renal Transplant Recipients

This study will evaluate the safety and efficacy of FTY720 combined with cyclosporine and corticosteroids in patients receiving a kidney transplant.

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Key information

Conditions

Renal Transplantation

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

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

Inclusion criteria

  • Completion of Core study

Exclusion criteria

Other protocol-defined exclusion criteria may apply.

Treatment and study plan

FTY720

Drug

Primary outcomes

  1. IA, IB, IIA, IIB or III diagnosed by biopsy according to Banff 97 criteria within 36 months post transplant

  2. Permanent resumption of dialysis within 36 months post transplant

  3. Surgical removal of graft within 36 months post transplant

  4. Death within 36 months post transplant

  5. Discontinuation within 36 months post transplant

Secondary outcomes

  1. FEV1 , FVC, DLCO within 36 months post transplant

  2. Serum creatinine and estimated creatinine clearance within 36 months post transplant

  3. Absolute lymphocyte count within 36 months post transplant

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

Two-year Extension of a One-year, Multicenter, Randomized, Partially-blinded Study of the Safety and Efficacy of FTY720 Combined With Corticosteroids and Full or Reduced-dose Cyclosporine, USP [Modified] (Novartis Brand) in de Novo Adult Renal Transplant Recipients

Important dates

Study start
2002
Primary completion
2004
First posted
Oct 17, 2005
Registry last updated
Nov 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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