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A Phase 1 Study to Evaluate PK, Safety and Tolerability of AMG 416

2017-09-15 00:23:21 | BioPortfolio

Summary

This is a multiple dose, double-blind, randomized, placebo-controlled clinical study conducted in Chinese subjects residing in Mainland China with chronic kidney disease receiving hemodialysis. The treatment duration will be approximately 4 weeks with a post treatment followup of 4 weeks. A dose will be given at each scheduled hemodialysis session (Dose administered three times a week for 4 weeks, for a total of 12 doses).

Study Design

Conditions

Secondary Hyperparathyroidism

Intervention

Hemodialysis, Hemodialysis, Hemodialysis, Hemodialysis

Status

Not yet recruiting

Source

Amgen

Results (where available)

View Results

Links

Published on BioPortfolio: 2017-09-15T00:23:21-0400

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Medical and Biotech [MESH] Definitions

Hospital units in which care is provided the hemodialysis patient. This includes hemodialysis centers in hospitals.

Long-term maintenance hemodialysis in the home.

The combination of hemodialysis and hemofiltration either simultaneously or sequentially. Convective transport (hemofiltration) may be better for removal of larger molecular weight substances and diffusive transport (hemodialysis) for smaller molecular weight solutes.

Solutions prepared for hemodialysis. The composition of the pre-dialysis solution may be varied in order to determine the effect of solvated metabolites on anoxia, malnutrition, acid-base balance, etc. Of principal interest are the effect of the choice of buffers (e.g., acetate or carbonate), the addition of cations (Na+, K+, Ca2+), and addition of carbohydrates (glucose).

Extracorporeal ultrafiltration technique without hemodialysis for treatment of fluid overload and electrolyte disturbances affecting renal, cardiac, or pulmonary function.

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