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

NCT00239902 | Completed Phase 2

• 1 other identifier: CFTY720A0121E1
• Study Type: interventional
• Target: 396
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Renal Transplantation

Keywords

Transplantation, kidney, and organ transplantation

Outcome Measures

Primary Outcomes (5)

• IA, IB, IIA, IIB or III 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

• Discontinuation within 36 months post transplant

Secondary Outcomes (3)

• FEV1 , FVC, DLCO within 36 months post transplant

• Serum creatinine and estimated creatinine clearance within 36 months post transplant

• Absolute lymphocyte count within 36 months post transplant

Interventions

FTY720 DRUG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Completion of Core study

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

MeSH Terms

Interventions

Fingolimod Hydrochloride

Intervention Hierarchy (Ancestors)

Sphingosine; Amino Alcohols; Alcohols; Organic Chemicals; Propylene Glycols; Glycols; Amines

Study Officials

• Novartis

  Novartis

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2005
• First Posted: October 17, 2005
• Study Start: May 1, 2002
• Primary Completion: November 1, 2004
• Last Updated: November 2, 2011

Record last verified: 2011-11