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Efficacy and Safety of FTY720 Versus Mycophenolate Mofetil (MMF, Roche Brand) in de Novo Adult Renal Transplant Recipients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00239863
First received: October 13, 2005
Last updated: February 21, 2017
Last verified: February 2017
  Purpose
This study will evaluate the safety and efficacy of FTY720 versus mycophenolate mofetil (MMF, Roche brand) combined with cyclosporine and corticosteroids in patients receiving a kidney transplant.

Condition Intervention Phase
Renal Transplantation Drug: FTY720 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official 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.

Resource links provided by NLM:


Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

Primary Outcome Measures:
  • 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 rati at Months 18, 24, 30 and 36 o
  • FEV1 , FVC, FEV1/FVC, DLCO and FEF 25%-75% at Months 18, 24, 30 and 36
  • Absolute lymphocyte count at Month 18, 24, 30 and 36.

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 684
Study Start Date: May 2004
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria

  • Completion of core study

Exclusion Criteria

Other protocol-defined exclusion criteria may apply.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00239863

Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Novartis
  More Information

Additional Information:
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00239863     History of Changes
Other Study ID Numbers: CFTY720A0125E1
Study First Received: October 13, 2005
Last Updated: February 21, 2017

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Transplantation, kidney,organ transplant

Additional relevant MeSH terms:
Mycophenolic Acid
Mycophenolate mofetil
Fingolimod Hydrochloride
Antibiotics, Antineoplastic
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 22, 2017