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

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00239876

Purpose

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

Condition	Intervention	Phase
Renal Transplantation	Drug: FTY720	Phase III

MedlinePlus related topics: Kidney Transplantation

Drug Information available for: FTY 720

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, Open-Label, Randomised Study to Evaluate the Safety and Efficacy of FTY720 Combined With Tacrolimus and Steroids Versus Mycophenolate Mofetyl Combined With Tacrolimus and Steroids, in De Novo Adult Renal Transplant Recipients

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, estimated creatinine clearance, assessment of other laboratory abnormalities and vital signs and measurement of urine protein. at Months 18, 24, 30 and 36
Pulmonary 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:

Estimated Enrollment:	140
Study Start Date:	May 2005

Eligibility

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

Criteria

Inclusion Criteria

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00239876

Sponsors and Collaborators

Novartis

Investigators

Study Director:

Novartis

More Information

No publications provided

Study ID Numbers:	CFTY720A2302E1
Study First Received:	October 13, 2005
Last Updated:	May 30, 2006
ClinicalTrials.gov Identifier:	NCT00239876 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Transplantation, kidney, and organ transplant

Study placed in the following topic categories:

Immunologic Factors
Fingolimod
Mycophenolate mofetil
Tacrolimus
Immunosuppressive Agents

Additional relevant MeSH terms:

Immunologic Factors
Fingolimod
Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009