Clinical trial NCT00239798: Efficacy and Safety of FTY720 in de Novo Adult Renal Transplant Recipients
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Renal Transplantation
Keywords: Transplantation, kidney, organ transplant
Lead sponsor: Novartis
Sponsor class: INDUSTRY
Collaborators: name: Mitsubishi Tanabe Pharma Corporation
First posted: 2005-10-17
Enrollment: 255
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria

* Patients who have completed the 12 Month visit of the Core trial either on or off study drug.
* Female capable of becoming pregnant are required to have a medically approved method of birth control until 3 Month after study medication was stopped.

Exclusion Criteria

- None

Primary outcomes:
measure: IA, IB, IIA, IIB, III, or humoral acute rejection diagnosed by biopsy according to Banff 97 criteria within 36 months post transplant
measure: Permanent resumption of dialysis within 36 months post transplant
measure: Surgical removal of graft within 36 months post transplant
measure: Death within 36 months post transplant
measure: Withdrawal of consent, death, or lost to follow up within 36 months post transplant
measure: Serum creatinine, and estimated creatinine clearance within 36 months post transplant
measure: FEV1 , FVC, FEV1/FVC, DLCO and FEF 25%-75% within 36 months post transplant
measure: Absolute lymphocyte count within 36 months post transplant
Secondary outcomes:
measure: IA, IB, IIA, IIB, III, or humoral rejection diagnosed by biopsy according to Banff 97 criteria at Month 24 and Month 36 post-transplant
measure: Permanent resumption of dialysis at Month 24 and Month 36 post-transplant
measure: Surgical removal of graft at Month 24 and Month 36 post-transplant
measure: Death at Month 24 and Month 36 post-transplant
measure: Withdrawal of consent, death, or lost to follow up at Month 24 and Month 36 post-transplant
measure: Serum creatinine, and estimated creatinine clearance at Month 24 and Month 36 post-transplant
measure: FEV1 , FVC, FEV1/FVC, DLCO and FEF 25%-75% at Month 24 and Month 36 post-transplant
measure: Absolute lymphocyte count at Month 18, 24, 30 and 36
Other outcomes:
Locations:
Study officials:
affiliation: Novartis
name: Novartis
role: STUDY_DIRECTOR
References:
citation: Tedesco-Silva H, Szakaly P, Shoker A, Sommerer C, Yoshimura N, Schena FP, Cremer M, Hmissi A, Mayer H, Lang P; FTY720 2218 Clinical Study Group. FTY720 versus mycophenolate mofetil in de novo renal transplantation: six-month results of a double-blind study. Transplantation. 2007 Oct 15;84(7):885-92. doi: 10.1097/01.tp.0000281385.26500.3b.