Efficacy and Safety of FTY720 Versus Mycophenolate Mofetil (MMF, Roche Brand) in De Novo Adult Renal Transplant Recipients - Full Text View

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00239863

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Kidney Transplantation

Drug Information available for: Mycophenolate mofetil hydrochloride Mycophenolate Mofetil FTY 720

U.S. FDA Resources

Further study details as provided by Novartis:

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

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria

Completion of core study

Exclusion Criteria

Other protocol-defined exclusion criteria may apply.

Contacts and Locations

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

Sponsors and Collaborators

Novartis

Investigators

Study Director:

Novartis

More Information

No publications provided

Study ID Numbers:	CFTY720A0125E1
Study First Received:	October 13, 2005
Last Updated:	May 30, 2006
ClinicalTrials.gov Identifier:	NCT00239863 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Transplantation, kidney,organ transplant

Study placed in the following topic categories:

Cyclosporine
Immunologic Factors
Fingolimod

Mycophenolate mofetil
Immunosuppressive Agents
Cyclosporins

Additional relevant MeSH terms:

Immunologic Factors
Fingolimod
Physiological Effects of Drugs

Mycophenolate mofetil
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 11, 2009