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NCT00099736 Clinical Trial

Efficacy and Safety of FTY720 in Patients Who Receive a Kidney Transplant

Kidney Transplantation Clinical Trial

Official title:
Efficacy and Safety of FTY720 in Patients Who Receive a Kidney Transplant

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00099736
Other study ID # CFTY720A0125
Secondary ID CFTY720 0125CFTY
Status Completed
Phase Phase 3
First received December 17, 2004
Last updated August 17, 2017
Start date May 7, 2003
Est. completion date September 19, 2005

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

Clinical Trial Summary

The efficacy and safety of FTY720 is being evaluated in patients who receive a kidney transplant.

Recruitment information / eligibility
Status Completed
Enrollment 696
Est. completion date September 19, 2005
Est. primary completion date September 19, 2005
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- First kidney transplantation

- Male and female patients

- Between 18 and 65 years old

Exclusion Criteria:

- Patients in need of multiple organ transplants

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• FTY720 5 mg + reduced-dose Neoral (RDN) + corticosteroids
FTY720 5 mg + reduced-dose Neoral (RDN) + corticosteroids
• FTY720 2.5 mg + full dose Neoral (FDN) + corticosteroids
FTY720 2.5 mg + full dose Neoral (FDN) + corticosteroids
• MMF 2 g + full-dose Neoral (FDN) + corticosteroids
mycophenolate mofetil (MMF) + full-dose Neoral (FDN) + corticosteroids

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

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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