CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 88 enrolled
Drug / intervention
AZD1722 (in-patient) +3 moredrug
Likely dose
AZD1722 (in-patient) 60 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01764854
NCT01764854Phase 2Completed
CompareCT.gov

A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Parallel Design Study to Evaluate the Pharmacodynamics, Safety, and Tolerability of AZD1722 in End-Stage Renal Disease Patients on Hemodialysis

Ardelyx·interventional·Posted Jan 10, 2013·Updated Aug 10, 2020

In Brief

A Phase 2 clinical trial evaluating AZD1722 (in-patient), Placebo (in-patient), and 2 other interventions for End Stage Renal Disease and 2 related conditions. Completed, enrolled 88 participants across 3 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEnd Stage Renal Disease, Chronic Kidney Disease Stage 5, ESRD
CountriesUnited States
CollaboratorsAstraZeneca

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJan 10, 2013
Enrollment StartJan 1, 2013
Primary CompletionOct 1, 2013
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 13.5 years ago

Interventions

AZD1722 (in-patient)drug

doses between 5 and 60 mg BID may be administered based on tolerability in a CPU setting

Placebo (in-patient)drug

Placebo, size and color matched to experimental drug administered in a CPU

AZD1722 (out-patient)drug

doses between 5 and 45 mg BID

Placebodrug

Placebo, size and color matched to experimental drug