drugset / Trial / NCT01764854

Pharmacodynamic Study of AZD1722 in End-stage Renal Disease Patients on Hemodialysis

NCT01764854 ↗

Phase 2 Completed 88 enrolled Ardelyx AstraZeneca · collab
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to determine if the study drug is safe, tolerable and active in reducing fluid overload/weight gain between dialysis sessions for patients with End Stage Renal Disease on Hemodialysis.

Timeline

Start
2013-01
Primary completion
2013-10
Completion
2013-10

Outcome

Missed primary endpoint

registry analysis (superiority test); AZD1722 Out-patient vs Placebo Out-patient; p = 0.46; ANCOVA NCT01764854 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Tenapanor Small molecule 5 mg —
Subject Tenapanor Small molecule 45 mg —
Subject Tenapanor Small molecule 60 mg —