Long Term Efficacy and Safety of FTY720 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: NCT00239811
• Other study ID #: CFTY720A0124E1
• Status: Completed
• Phase: Phase 3
• First received: October 13, 2005
• Last updated: November 1, 2011
• Start date: April 2004

Study information

• Verified date: November 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 684
• Est. primary completion date: May 2006
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria

• Patients who completed the 12 month core study

• Patients who gave written informed consent to participate in the study Exclusion Criteria

• Not applicable Other protocol-defined exclusion criteria may apply

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Renal Transplantation

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 ratio at Months 18, 24, 30 and 36
Primary	FEV1 , FVC, FEV1/FVC, DLCO and FEF 25%-75% at Months 18, 24, 30 and 36
Primary	Absolute lymphocyte count at Months 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