Long Term 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:
NCT00239811
First received: October 13, 2005
Last updated: November 1, 2011
Last verified: November 2011

October 13, 2005
November 1, 2011
April 2004
May 2006   (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 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, calculated creatinine clearance and urine-protein/creatinine ratio at Months 18, 24, 30 and 36
  • FEV1 , FVC, FEV1/FVC, DLCO and FEF 25%-75% at Months 18, 24, 30 and 36
  • Absolute lymphocyte count at Months 18, 24, 30 and 36.
Not Provided
Complete list of historical versions of study NCT00239811 on ClinicalTrials.gov Archive Site
  • Physical examinations at Months 18, 24, 30 and 36
  • Vital signs at Months 18, 24, 30 and 36
  • Electrocardiogram at Months 24 and 36
  • Chest X-ray Months 24 and 36
  • Safety laboratory tests 18, 24, 30 and 36
  • Ophthalmic evaluations 18, 24, 30 and 36
  • AEs and SAEs
  • FTY720/CsA levels at Months 18, 24, 30 and 36
Not Provided
Not Provided
Not Provided
 
Long Term Efficacy and Safety of FTY720 in de Novo Adult Renal Transplant Recipients
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

This study will evaluate the long term 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: Open Label
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
May 2006   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
Not Provided
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00239811
CFTY720A0124E1
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