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

Phase 2

Completed

• Conditions: End Stage Renal Disease; ESRD; Chronic Kidney Disease Stage 5
• Interventions: Drug: Placebo (in-patient); Drug: AZD1722 (out-patient); Drug: AZD1722 (in-patient); Drug: Placebo

• Registration Number: NCT01764854
• Lead Sponsor: Ardelyx

Brief 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.

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-01-04
• Study First Submitted QC: 2013-01-08
• Study First Posted: 2013-01-10
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Results First Submitted: 2020-05-21
• Status Verified: 2020-08
• Results First Submitted QC: 2020-08-06
• Last Update Submitted: 2020-08-06
• Results First Posted: 2020-08-10
• Last Update Posted: 2020-08-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

• Males or females aged 18 to 80 years, inclusive;
• Body mass index between 18 and 45 kg/m2, inclusive;
• Ambulatory (≥ 6 months) maintenance hemodialysis;
• Stable dialysis treatment regimen 3x/week for ≥ 2 months prior to screening visit.

Exclusion Criteria

• Currently taking diuretic medication;
• Has a urine production of ≥ 200 ml/day (based on a 24-hour measurement starting on Day -1 and completed prior to randomization);
• Predialysis systolic BP >200 mmHg or diastolic BP >110 mmHg on two successive occasions during the 2-week run-in period;
• Predialysis SBP < 110 mmHg on two successive occasions during the 2-week run-in period

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo- in patient	Placebo (in-patient)	Placebo (size and color matched to experimental drug) administered in a clinical pharmacology unit
AZD1722 out-patient	AZD1722 (out-patient)	Tenapanor
AZD1722- in patient	AZD1722 (in-patient)	Tenapanor administered in a clinical pharmacology unit
Placebo out-patient	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Change in Mean Weekly Interdialytic Weight Gain (IDWG)	Run-in period (Weeks -2 and -1) versus Week 4 (end of treatment)	Patients are weighed pre dialysis prior to their first dialysis of the week. This measure looks at the change in pre-dialysis weight over time

Secondary Outcome Measures

Name	Time	Method
Stool Sodium Content	Days 1 through 7	The amount of sodium in a days worth of stool output

Trial Locations

Locations (3)

Denver Nephrology; 🇺🇸 Denver, Colorado, United States

DaVita Clinical Research; 🇺🇸 Minneapolis, Minnesota, United States

Southwest Clinical Research Institute; 🇺🇸 Tempe, Arizona, United States