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Completed

NCT Number: NCT00239798

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

  • Patients who have completed the 12 Month visit of the Core trial either on or off study drug.
  • Female capable of becoming pregnant are required to have a medically approved method of birth control until 3 Month after study medication was stopped.

Exclusion criteria

  • None

Treatment and study plan

FTY720

Drug

Primary outcomes

  1. IA, IB, IIA, IIB, III, or humoral acute rejection 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. Withdrawal of consent, death, or lost to follow up within 36 months post transplant

  6. Serum creatinine, and estimated creatinine clearance within 36 months post transplant

  7. FEV1 , FVC, FEV1/FVC, DLCO and FEF 25%-75% within 36 months post transplant

  8. Absolute lymphocyte count within 36 months post transplant

Secondary outcomes

  1. IA, IB, IIA, IIB, III, or humoral rejection diagnosed by biopsy according to Banff 97 criteria at Month 24 and Month 36 post-transplant

  2. Permanent resumption of dialysis at Month 24 and Month 36 post-transplant

  3. Surgical removal of graft at Month 24 and Month 36 post-transplant

  4. Death at Month 24 and Month 36 post-transplant

  5. Withdrawal of consent, death, or lost to follow up at Month 24 and Month 36 post-transplant

  6. Serum creatinine, and estimated creatinine clearance at Month 24 and Month 36 post-transplant

  7. FEV1 , FVC, FEV1/FVC, DLCO and FEF 25%-75% at Month 24 and Month 36 post-transplant

  8. Absolute lymphocyte count at Month 18, 24, 30 and 36

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Collaborators

  • Tanabe Pharma Corporation

Registry information

Official study title

A 24-month Extension of a One-year, Multicenter, Double Blinded Double Dummy, Randomized Study to Evaluate the Safety and Efficacy of Two Doses of FTY720 Combined With Full-dose Cyclosporine, USP [Modified] (Novartis Brand) and Steroids Versus Mycophenolate Mofetil Combined With Full-dose Cyclosporine, USP [Modified] (Novartis Brand) and Steroids, in Adult de Novo Renal Transplant Recipients

Important dates

Study start
2004
Primary completion
2006
First posted
Oct 17, 2005
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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