drugset / Trial / NCT02965053

A Phase1 Study to Explore the Safety of EOS789 in Patients With Chronic Kidney Disease and Hyperphosphatemia on Hemodialysis

NCT02965053

Phase 1 Completed 26 enrolled Chugai Pharmaceutical
RandomizedCrossoverDouble-blindTreatment

Summary

This study is a randomized study designed as a 2x2 cross-over in two periods (Period 1 and Period 2) to assess the safety, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy of EOS789 in patients with chronic kidney disease (CKD) and hyperphosphatemia receiving hemodialysis. Period 1 is double-blind and Period 2 is open-label. Period 1 and Period 2 are identical with regard to the design, inclusion/exclusion criteria, and assessments. EOS789 and its combination with sevelamer carbonate are tested in Period 1 and Period 2 respectively.

Timeline

Start
2016-12
Primary completion
2018-08
Completion
2018-08

Drugs

EvaluationDrugModalityDoseRoute
Subject EOS789 Unknown
Background sevelamer Other / unclassified

Indications