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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00239785
First received: October 13, 2005
Last updated: November 1, 2011
Last verified: November 2011

October 13, 2005
November 1, 2011
April 2003
April 2005   (final data collection date for primary outcome measure)
  • IA, IB, IIA, IIB, III, or humoral rejection diagnosed by biopsy according to Banff 97 criteria within 12 months post transplant
  • Permanent resumption of dialysis within 12 months post transplant
  • Surgical removal of graft within 12 months post transplant
  • Death within 12 months post transplant
  • Withdrawal of consent, death, or lost to follow up within 12 months post transplant
Not Provided
Complete list of historical versions of study NCT00239785 on ClinicalTrials.gov Archive Site
  • FEV1 , FVC, FEV1/FVC, DLCO and FEF 25%-75% at day 28, months 6 and 12
  • Serum creatinine
  • Cystatin C at months 3, 6, and 12
  • Proteinuria at day 28, months 6 and 12
  • Absolute lymphocyte count at screening, baseline, day 1, 7, 14, and 28, months 2, 3, 6, 9, and 12
Not Provided
Not Provided
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Efficacy and Safety of FTY720 in de Novo Adult Renal Transplant Recipients
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

This study will evaluate the safety and efficacy of FTY720 combined with cyclosporine and corticosteroids in patients receiving a kidney organ transplant

Not Provided
Interventional
Phase 3
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
684
Not Provided
April 2005   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
Not Provided
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00239785
CFTY720A0124
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
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