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
• 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
• 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. primary completion date: April 2005
• 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

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, 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

External Links

•   Novartis Clinical Trial Results Database