Text Size

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

This study has been completed.
Sponsor:
Collaborator:
Mitsubishi Tanabe Pharma Corporation
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00239798
First received: October 13, 2005
Last updated: November 1, 2011
Last verified: November 2011
History of Changes

October 13, 2005
November 1, 2011
November 2004
November 2006   (final data collection date for primary outcome measure)
  • IA, IB, IIA, IIB, III, or humoral acute rejection diagnosed by biopsy according to Banff 97 criteria within 36 months post transplant
  • Permanent resumption of dialysis within 36 months post transplant
  • Surgical removal of graft within 36 months post transplant
  • Death within 36 months post transplant
  • Withdrawal of consent, death, or lost to follow up within 36 months post transplant
  • Serum creatinine, and estimated creatinine clearance within 36 months post transplant
  • FEV1 , FVC, FEV1/FVC, DLCO and FEF 25%-75% within 36 months post transplant
  • Absolute lymphocyte count within 36 months post transplant
Not Provided
Complete list of historical versions of study NCT00239798 on ClinicalTrials.gov Archive Site
  • IA, IB, IIA, IIB, III, or humoral rejection diagnosed by biopsy according to Banff 97 criteria at Month 24 and Month 36 post-transplant
  • Permanent resumption of dialysis at Month 24 and Month 36 post-transplant
  • Surgical removal of graft at Month 24 and Month 36 post-transplant
  • Death at Month 24 and Month 36 post-transplant
  • Withdrawal of consent, death, or lost to follow up at Month 24 and Month 36 post-transplant
  • Serum creatinine, and estimated creatinine clearance at Month 24 and Month 36 post-transplant
  • FEV1 , FVC, FEV1/FVC, DLCO and FEF 25%-75% at Month 24 and Month 36 post-transplant
  • Absolute lymphocyte count at Month 18, 24, 30 and 36
Not Provided
Not Provided
Not Provided
 
Efficacy and Safety of FTY720 in de Novo Adult Renal Transplant Recipients
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

This study will evaluate the safety and efficacy of FTY720 combined with cyclosporine and corticosteroids in patients receiving a kidney transplant.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Renal Transplantation
Drug: FTY720
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
255
Not Provided
November 2006   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
Not Provided
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00239798
CFTY720A2218E1
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Mitsubishi Tanabe Pharma Corporation
Study Director: Novartis Novartis
Novartis
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP