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| Reference : A multicenter, randomized, double-blind study comparing different FK778 doses (manitimus... |
| Scientific journals : Article | |||
| Human health sciences : Surgery | |||
| http://hdl.handle.net/2268/129360 | |||
| A multicenter, randomized, double-blind study comparing different FK778 doses (manitimus) with tacrolimus and steroids vs. MMF with tacrolimus and steroids in renal transplantation | |
| English | |
| Wlodarczyk, Zbigniew [] | |
| Vanrenterghem, Yves [] | |
| Krämer, Bernhard k [] | |
SQUIFFLET, Jean-Paul  [Centre Hospitalier Universitaire de Liège - CHU > > Chirurgie abdominale- endocrinienne et de transplantation >] | |
| Ostrowski, Marek [] | |
| 2012 | |
| BMC Nephrology | |
| BioMed Central | |
| 13 | |
| 68 | |
| 1471-2369 | |
| [en] Background: This multicenter phase II study in renal transplantation compared 3 concentration-controlled ranges
of FK778 (manitimus) with mycophenolate mofetil (MMF) both given in combination with tacrolimus and corticosteroids. Methods: 364 patients were randomized to 12-month treatment: high-level FK778 group (H, N = 87) received 4x600mg/day (4 days) followed by 120 mg/day; mid-level FK778 group (M, N = 92) received 3x600mg/day (3 days) followed by 110 mg/day, low-level FK778 group (L, N = 92) received 2x600mg/day (2 days) followed by 100 mg/day, and control group received MMF 1 g/day (MMF, N = 93). After week 6, FK778 doses were adjusted to trough ranges of 75–125 μg/mL (H), 50–100 μg/mL (M) and 25–75 μg/mL (L). Tacrolimus and steroids were administered at the same dose in each of the 4 groups. Results: Biopsy proven acute rejection (BPAR) at 24 weeks, the primary study endpoint, was comparable in the L (22.8%) and MMF (17.2%) groups but higher in the H (34.5%) and M (29.3%) groups. BPAR at 12 months was comparable in the L (23.9%) and MMF (19.4%) groups but higher in the H (34.5%) and M (31.5%) groups. Graft and patient survival were lowest in the H group and renal function was poorest in the H and M groups. Premature study withdrawal was highest in the H group. Conclusions: Efficacy was similar between the low-level FK778 and MMF groups. Increased FK778 exposure was poorly tolerated and did not improve efficacy. | |
| Researchers ; Professionals ; Students | |
| http://hdl.handle.net/2268/129360 |
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