Efficacy and Safety of FTY720 in De Novo Adult Renal Transplant Recipients - Full Text View

Sponsors and Collaborators:	Novartis Mitsubishi Tanabe Pharma Corporation
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00239798

Purpose

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

Condition	Intervention	Phase
Renal Transplantation	Drug: FTY720	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Kidney Transplantation

Drug Information available for: FTY 720

Further study details as provided by Novartis:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	255
Study Start Date:	November 2004

Eligibility

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

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00239798

Sponsors and Collaborators

Novartis

Mitsubishi Tanabe Pharma Corporation

Investigators

Study Director:

Novartis

More Information

No publications provided

Study ID Numbers:	CFTY720A2218E1
Study First Received:	October 13, 2005
Last Updated:	May 30, 2006
ClinicalTrials.gov Identifier:	NCT00239798 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
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 11, 2009