Kidney Transplantation
Conditions
Keywords
De novo kidney recipients,, EC-MPS,, tacrolimus,, efficacy,, safety,, glomerular filtration rate, Treatment in de novo kidney recipients
Brief summary
This study will investigate the safety, tolerability and efficacy of EC-MPS with tacrolimus at both reference and reduced levels. This study will take into account safety aspects such as decreased renal toxicity by reducing the overall exposure to tacrolimus.
Interventions
DRUGEC-MPS, Tacrolimus
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Inclusion criteria
* Male or female kidney transplantation patients, 18 to 70 years of age, receiving a primary cadaveric, living unrelated, or non-HLA identical living related donor kidney. * The renal cold ischemic time (CIT) must be \<30 hours * The age of the donor must be between 10 and 65 years
Exclusion criteria
* Patients who have previously received an organ transplant * Patients who are recipients of a multiple organ transplants * Recipients of non heart-beating donor organs * ABO incompatibility against the donor Other protocol-defined
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| renal function at 6 months posttransplant as measured by glomerular filtration rate | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Renal function as measured by calculated creatinine clearance | — |
| Cockcroft-Gaultand serum creatinine at 6 months | — |
| Gastrointestinal tolerability as measured by gastrointestinal | — |
| Efficacy as measured by combined incidence of biopsy proven acute rejection episodes, graft loss, and death at 6 months | — |
| Safety as measured by incidence of adverse events | — |
| Effects on glucose metabolism at months 3 and 6 after transplantation. | — |
| symptom rating scale (GSRS) at various time points | — |
Countries
United States
Outcome results
None listed