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

End Stage Renal Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01764854
• Other study ID #: D5611C00001
• Status: Completed
• Phase: Phase 2
• Start date: January 2013
• Est. completion date: October 2013

Study information

• Verified date: August 2020
• Source: Ardelyx
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Disease Stage 5
• End Stage Renal Disease
• ESRD
• Kidney Diseases
• Kidney Failure, Chronic
• Renal Insufficiency, Chronic

Intervention

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

Locations

Country	Name	City	State
United States	Denver Nephrology	Denver	Colorado
United States	DaVita Clinical Research	Minneapolis	Minnesota
United States	Southwest Clinical Research Institute	Tempe	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Ardelyx	AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Mean Weekly Interdialytic Weight Gain (IDWG)	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	Run-in period (Weeks -2 and -1) versus Week 4 (end of treatment)
Secondary	Stool Sodium Content	The amount of sodium in a days worth of stool output	Days 1 through 7