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NCT00239785 Clinical Trial

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

Renal Transplantation Clinical Trial

Official title:
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 NCT00239785
Other study ID # CFTY720A0124
Secondary ID
Status Completed
Phase Phase 3
First received October 13, 2005
Last updated August 18, 2017
Start date April 2003

Study information
Verified date August 2017
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
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 organ transplant

Recruitment information / eligibility
Status Completed
Enrollment 684
Est. completion date
Est. primary completion date April 2005
Accepts healthy volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria

- Male and female patients of any race between 18 to 65 years old (inclusive)

- Patients scheduled to undergo a primary cadaveric or primary non-HLA identical living donor kidney transplantation

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

- Recipients of multi-organ transplantation or foreseen to receive a non-renal allograft during the study period

- Graft cold ischemia time greater than 40 hours.

- Patients with pulse rate < 50 beats per minute (bpm) at screening Other protocol-defined exclusion criteria may apply

Study Design

Related Conditions & MeSH terms

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 12 months post transplant
Primary Permanent resumption of dialysis within 12 months post transplant
Primary Surgical removal of graft within 12 months post transplant
Primary Death within 12 months post transplant
Primary Withdrawal of consent, death, or lost to follow up within 12 months post transplant
Secondary FEV1 , FVC, FEV1/FVC, DLCO and FEF 25%-75% at day 28, months 6 and 12
Secondary Serum creatinine
Secondary Cystatin C at months 3, 6, and 12
Secondary Proteinuria at day 28, months 6 and 12
Secondary Absolute lymphocyte count at screening, baseline, day 1, 7, 14, and 28, months 2, 3, 6, 9, and 12
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