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Clinical Trials/NCT00239798
NCT00239798CompletedPhase 2

A 24-month Extension of a One-year, Multicenter, Double Blinded Double Dummy, Randomized Study to Evaluate the Safety and Efficacy of Two Doses of FTY720 Combined With Full-dose Cyclosporine, USP [Modified] (Novartis Brand) and Steroids Versus Mycophenolate Mofetil Combined With Full-dose Cyclosporine, USP [Modified] (Novartis Brand) and Steroids, in Adult de Novo Renal Transplant Recipients

Novartis Pharmaceuticals0 sites255 target enrollmentStarted: November 2004Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
255
Primary Endpoint
IA, IB, IIA, IIB, III, or humoral acute rejection diagnosed by biopsy according to Banff 97 criteria within 36 months post transplant
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

IA, IB, IIA, IIB, III, or humoral acute 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, and estimated creatinine clearance within 36 months post transplant

FEV1 , FVC, FEV1/FVC, DLCO and FEF 25%-75% within 36 months post transplant

Absolute lymphocyte count within 36 months post transplant

Secondary Outcomes

  • Withdrawal of consent, death, or lost to follow up at Month 24 and Month 36 post-transplant
  • IA, IB, IIA, IIB, III, or humoral rejection diagnosed by biopsy according to Banff 97 criteria at Month 24 and Month 36 post-transplant
  • Permanent resumption of dialysis at Month 24 and Month 36 post-transplant
  • Surgical removal of graft at Month 24 and Month 36 post-transplant
  • Death at Month 24 and Month 36 post-transplant
  • Serum creatinine, and estimated creatinine clearance at Month 24 and Month 36 post-transplant
  • FEV1 , FVC, FEV1/FVC, DLCO and FEF 25%-75% at Month 24 and Month 36 post-transplant
  • Absolute lymphocyte count at Month 18, 24, 30 and 36

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

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