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OpenTrials
Completed

NCT Number: NCT00099736

Efficacy and Safety of FTY720 in 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 3

Primary location

Phoenix, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • First kidney transplantation
  • Male and female patients
  • Between 18 and 65 years old

Exclusion criteria

  • Patients in need of multiple organ transplants

Treatment and study plan

FTY720 5 mg + reduced-dose Neoral (RDN) + corticosteroids

Drug

FTY720 5 mg + reduced-dose Neoral (RDN) + corticosteroids

FTY720 2.5 mg + full dose Neoral (FDN) + corticosteroids

Drug

FTY720 2.5 mg + full dose Neoral (FDN) + corticosteroids

MMF 2 g + full-dose Neoral (FDN) + corticosteroids

Drug

mycophenolate mofetil (MMF) + full-dose Neoral (FDN) + corticosteroids

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

Important dates

Study start
2003
Primary completion
2005
Study completion
2005
First posted
Dec 20, 2004
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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