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Completed

NCT Number: NCT00239811

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

This study will evaluate the long term 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

  • Patients who completed the 12 month core study
  • Patients who gave written informed consent to participate in the study Exclusion Criteria
  • Not applicable 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 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, calculated creatinine clearance and urine-protein/creatinine ratio at Months 18, 24, 30 and 36

  7. FEV1 , FVC, FEV1/FVC, DLCO and FEF 25%-75% at Months 18, 24, 30 and 36

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

Secondary outcomes

  1. Physical examinations at Months 18, 24, 30 and 36

  2. Vital signs at Months 18, 24, 30 and 36

  3. Electrocardiogram at Months 24 and 36

  4. Chest X-ray Months 24 and 36

  5. Safety laboratory tests 18, 24, 30 and 36

  6. Ophthalmic evaluations 18, 24, 30 and 36

  7. AEs and SAEs

  8. FTY720/CsA levels at Months 18, 24, 30 and 36

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

A Two-year Extension to 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
2004
Primary completion
2006
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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