Kidney Transplantation
Conditions
Keywords
Kidney, transplantation, rejection, immunosuppression
Brief summary
The efficacy and safety of FTY720 is being evaluated in patients who receive a kidney transplant.
Interventions
DRUGFTY720 5 mg + reduced-dose Neoral (RDN) + corticosteroids
FTY720 5 mg + reduced-dose Neoral (RDN) + corticosteroids
DRUGFTY720 2.5 mg + full dose Neoral (FDN) + corticosteroids
FTY720 2.5 mg + full dose Neoral (FDN) + corticosteroids
DRUGMMF 2 g + full-dose Neoral (FDN) + corticosteroids
mycophenolate mofetil (MMF) + full-dose Neoral (FDN) + corticosteroids
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* First kidney transplantation * Male and female patients * Between 18 and 65 years old
Exclusion criteria
* Patients in need of multiple organ transplants
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| withdrawal of consent, death, or lost to follow up within 12 months post transplant | — |
| IA, IB, IIA, IIB, III, or humoral rejection diagnosed by biopsy according to Banff 97 criteria within 12 months post transplant | — |
| permanent resumption of dialysis within 12 months post transplant | — |
| surgical removal of graft within 12 months post transplant | — |
| death within 12 months post transplant | — |
Secondary
| Measure | Time frame |
|---|---|
| FEV1 , FVC, FEV1/FVC, DLCO and FEF 25%-75% at day 28, months 6 and 12 | — |
| serum creatinine | — |
| cystatin C at months 3, 6, and 12 | — |
| proteinuria at day 28, months 6 and 12 | — |
| absolute lymphocyte count at screening, baseline, day 1, 7, 14, and 28, months 2, 3, 6, 9, and 12 | — |
Countries
United States
Outcome results
None listed