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NCT00239863 Clinical Trial

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

Renal Transplantation Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00239863
Other study ID # CFTY720A0125E1
Secondary ID
Status Completed
Phase Phase 3
First received October 13, 2005
Last updated February 21, 2017
Start date May 2004

Study information
Verified date February 2017
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 684
Est. completion date
Est. primary completion date May 2006
Accepts healthy volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria

- Completion of core study

Exclusion Criteria

Other protocol-defined exclusion criteria may apply.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• FTY720

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Novartis Pharmaceuticals

Outcome
Type Measure Description Time frame Safety issue
Primary IA, IB, IIA, IIB, III, or humoral rejection diagnosed by biopsy according to Banff 97 criteria within 36 months post transplant
Primary Permanent resumption of dialysis within 36 months post transplant
Primary Surgical removal of graft within 36 months post transplant
Primary Death within 36 months post transplant
Primary Withdrawal of consent, death, or lost to follow up within 36 months post transplant
Primary Serum creatinine, calculated creatinine clearance and urine-protein/creatinine rati at Months 18, 24, 30 and 36 o
Primary FEV1 , FVC, FEV1/FVC, DLCO and FEF 25%-75% at Months 18, 24, 30 and 36
Primary Absolute lymphocyte count at Month 18, 24, 30 and 36.
Secondary Physical examinations at Months 18, 24, 30 and 36
Secondary Vital signs at Months 18, 24, 30 and 36
Secondary Electrocardiogram at Months 24 and 36
Secondary Chest X-ray Months 24 and 36
Secondary Safety laboratory tests 18, 24, 30 and 36
Secondary Ophthalmic evaluations 18, 24, 30 and 36
Secondary AEs and SAEs
Secondary FTY720/CsA levels at Months 18, 24, 30 and 36
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