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Completed

NCT Number: NCT00239785

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 organ 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 3

Who can participate

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

Inclusion criteria

  • Male and female patients of any race between 18 to 65 years old (inclusive)
  • Patients scheduled to undergo a primary cadaveric or primary non-HLA identical living donor kidney transplantation
  • Patients who gave written informed consent to participate in the study Exclusion Criteria
  • Recipients of multi-organ transplantation or foreseen to receive a non-renal allograft during the study period
  • Graft cold ischemia time greater than 40 hours.
  • Patients with pulse rate < 50 beats per minute (bpm) at screening Other protocol-defined exclusion criteria may apply

Treatment and study plan

FTY720

Drug

Primary outcomes

  1. IA, IB, IIA, IIB, III, or humoral rejection diagnosed by biopsy according to Banff 97 criteria within 12 months post transplant

  2. Permanent resumption of dialysis within 12 months post transplant

  3. Surgical removal of graft within 12 months post transplant

  4. Death within 12 months post transplant

  5. Withdrawal of consent, death, or lost to follow up within 12 months post transplant

Secondary outcomes

  1. FEV1 , FVC, FEV1/FVC, DLCO and FEF 25%-75% at day 28, months 6 and 12

  2. Serum creatinine

  3. Cystatin C at months 3, 6, and 12

  4. Proteinuria at day 28, months 6 and 12

  5. Absolute lymphocyte count at screening, baseline, day 1, 7, 14, and 28, months 2, 3, 6, 9, and 12

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

A One-year, Multicenter, Partially Blinded, Double-dummy, Randomized Study to Evaluate the Efficacy and Safety of FTY720 Combined With Reduced-dose or Full-dose Cyclosporine, USP [Modified] (Novartis Brand) and Corticosteroids Versus Mycophenolate Mofetil Combined With Full-dose Cyclosporine, USP [Modified] (Novartis Brand) and Corticosteroids, in de Novo Adult Renal Transplant Recipients

Important dates

Study start
2003
Primary completion
2005
First posted
Oct 17, 2005
Registry last updated
Aug 22, 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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