Kidney Transplant
Conditions
Sponsors
Novartis Pharma. K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Written informed consent obtained before any assessment. - Male or female patient >= 18 years old. - Up to date vaccination as per local immunization schedules. - Recipients of a kidney transplant - Recipients of a primary kidney transplant from a heart-beating deceased, living unrelated or non-HLA identical living related donors.
Exclusion criteria
Exclusion criteria: - Multi-organ transplant recipients or prior kidney transplant. - Recipients of an organ from a non-heart beating donor. - Recipient of an organ from an HLA identical living related donor. - ABO incompatible or complement-dependent lymphocytotoxic (CDC) crossmatch positive transplant - Recipients of kidneys from donors who are older than 65 years. - Recipients of kidneys from donors with terminal serum creatinine > 2 mg/dL. - Patients at high immunological risk for rejection - Patient who is anti-HIV positive, HBsAg-positive or anti-HCV positive (without proof of sustained viral response (SVR) after anti-HCV treatment). - Recipient of a kidney from a donor who tests positive for HIV, HBsAg/HBc positive or HCV. - A negative Epstein Barr virus (EBV) test. - Evidence of advanced liver disease (Child-Pugh C), or any sign of liver decompensation. - Patient with severe systemic infections, current or within the two weeks prior to randomization. - History of malignancy of any organ system, treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases, with the exception of localized excised non-melanomatous skin lesions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy - Proportion of patients with composite event (BPAR, Graft Loss or Death) [ Time Frame: Month 12 ] - Proportion of patients with composite event over 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy pharmacokinetics other - Mean eGFR [ Time Frame: Baseline to month 12 ] - Proportion of patients with AEs, SAEs, infections, malignancies, thromboembolic events, major adverse cardiovascular events, new onset diabetes mellitus (NODM) [ Time Frame: Baseline to month 12 ] - Tolerability assessment by rate of premature discontinuation from study, premature discontinuation of study drug, dose interruption and dose adjustment[ Time Frame: Baseline to month 12 ] | — |
Countries
Europe, Japan, North America, Oceania, South America
Contacts
Public ContactHiroyuki Yamada
Novartis Pharma. K.K.
Outcome results
None listed