NCT01764854

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: Ardelyx · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a Phase 2, multi-center, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and pharmacodynamics of the study drug in male and female patients with end-stage renal disease on hemodialysis. The study consists of a 2 week treatment-free run-in period where entry criteria are verified, a 4-week treatment period, of which the first week of treatment will be performed as an in-patient study in a clinical pharmacology unit (CPU) and the remaining three weeks of treatment will performed as an out-patient study, and a 2-week treatment-free follow-up period. Safety assessments will be performed at regular intervals and will include clinical and vital signs, clinical laboratory evaluations, ECGs, and AE monitoring. Pharmacodynamic assessments will include, but are not limited to, interdialytic weight gain (IDWG), blood pressure, and stool sodium excretion. Pharmacokinetic assessments will include blood sampling for measurement of study drug plasma concentrations.

Conditions

• End Stage Renal Disease
• Chronic Kidney Disease Stage 5
• ESRD

Interventions

Type	Name	Description
DRUG	AZD1722 (in-patient)	doses between 5 and 60 mg BID may be administered based on tolerability in a CPU setting
DRUG	Placebo (in-patient)	Placebo, size and color matched to experimental drug administered in a CPU
DRUG	AZD1722 (out-patient)	doses between 5 and 45 mg BID
DRUG	Placebo	Placebo, size and color matched to experimental drug

Timeline

• Start date: 2013-01-01
• Primary completion: 2013-10-01
• Completion: 2013-10-01
• First posted: 2013-01-10
• Last updated: 2020-08-10
• Results posted: 2020-08-10

Locations

3 sites across 1 country: United States