10 results
The primary objective of this study is to determine the antialbuminuric response of vitamin D analogue in addition to ACE-inhibitor and low-sodium diet, in renal patients.
The objectives of this open-label study are to evaluate the efficacy (GL-3 clearance), pharmacokinetics (PK), and safety parameters (including immunogenicity) for 2 alternative dose regimens of Fabrazyme (0.5 mg/kg every 2 weeks [q2w] and 1.0 mg/kg…
Primary: To demonstrate the superiority of the insulin glargine/lixisenatide fixed ratio combination to insulinglargine in HbA1c change from baseline to week 30.Secondary: To compare the overall efficacy and safety of insulin glargine/lixisenatide…
In this pilot study, we are setting on to investigate the differential effects of the VDR activator paricalcitol versus calcitriol on peritoneal transport, peritoneal inflammation and peritoneal defense parameters in PD patients.
The primary objectives of this study are: * To characterize the effects of 150 mg and 450 mg of AT1001 administered 2 hours before administration of agalsidase on the safety and plasma pharmacokinetics of agalsidase in subjects with Fabry Disease*…
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To evaluate the safety and efficacy of PRX-102 compared to agalsidase beta in Fabry disease patients with impaired renal function.
Secondary objectives:The secondary objectives include demonstration of clinical efficacy of SCIT with BM41 alone, with BM41 plus VD3 and with VD3 alone, all three compared to placebo. Efficacy will be analysed for the upper airways by titrated nasal…
The primary objective is to evaluate whether 2.5 µg VD3 analogue (Zemplar® * Abbvie) in multiple subcutaneously administered doses induces a more favourable (read: anti-inflammatory) systemic immune modulation both in general parameters and allergen…
The aim of this clinical phase IIa randomized, double-blind, placebo-controlled study is to investigate tolerability/ safety and clinical and immunological effects of the addition of a subcuteaneous injection of a VD3 analogue in the vicinity of the…