Calendario›AMGN›Etelcalcetide

Etelcalcetide

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

Ensayo de AMGEN INC en Hiperparatiroidismo secundario.

Fase

Fase 1

Estado

Completado

Participantes

33

previstos

Centros

5

Fin del objetivo primario

feb 2019

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, triple ciego. Comenzó en mar 2018.

Qué mide

Parametro farmacocinetico (PK): Tiempo hasta la concentracion maxima del farmaco (Tmax) de etelcalcetida plasmatica en los dias 1 y 27 (Days 1 and 27; PK blood sampling predialysis, and at 10, 30, 60, 90 min postdose, as well as on Day 2 and 28 between 18 and 30 hours after study drug administration) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis was a multiple-dose, double-blind, randomized, placebo-controlled study. Chinese subjects residing in Mainland China with chronic kidney disease (CKD) receiving hemodialysis were randomized in a 3:1 ratio to receive 5 mg intravenous (IV) of etelcalcetide or placebo 3 times a week (TIW) for approximately 4 weeks, with a subsequent follow up period of approximately 4 weeks. Doses were given at the end of each scheduled hemodialysis session on study days 1 through day 27 and subject participation was complete after day 55 end-of-study (EOS) procedures were performed. Doses were administered TIW for 4 weeks, for a total of 12 doses.

Más ensayos de AMGN

Todos los de AMGN, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT03283098), actualizada en ene 2020.