Efficacy and Safety of FTY720 in de Novo Adult Renal Transplant Recipients

Renal Transplantation Clinical Trial

Official title:

Two-year Extension of a One-year, Multicenter, Randomized, Partially-blinded Study of the Safety and Efficacy of FTY720 Combined With Corticosteroids and Full or Reduced-dose Cyclosporine, USP [Modified] (Novartis Brand) in de Novo Adult Renal Transplant Recipients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00239902
• Other study ID #: CFTY720A0121E1
• Status: Completed
• Phase: Phase 2
• First received: October 13, 2005
• Last updated: November 1, 2011
• Start date: May 2002

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 safety and efficacy of FTY720 combined with cyclosporine and corticosteroids in patients receiving a kidney transplant.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 396
• Est. primary completion date: November 2004
• Gender: Both
• 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

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 or III 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	Discontinuation within 36 months post transplant
Secondary	FEV1 , FVC, DLCO within 36 months post transplant
Secondary	Serum creatinine and estimated creatinine clearance within 36 months post transplant
Secondary	Absolute lymphocyte count within 36 months post transplant