Clinical trial NCT01764854: Pharmacodynamic Study of AZD1722 in End-stage Renal Disease Patients on Hemodialysis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: End Stage Renal Disease
Chronic Kidney Disease Stage 5
ESRD
Keywords: Hemodialysis
Lead sponsor: Ardelyx
Sponsor class: INDUSTRY
Collaborators: name: AstraZeneca
First posted: 2013-01-10
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Mean Weekly Interdialytic Weight Gain (IDWG)
timeFrame: Run-in period (Weeks -2 and -1) versus Week 4 (end of treatment)
Secondary outcomes:
measure: Stool Sodium Content
timeFrame: Days 1 through 7
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Southwest Clinical Research Institute
state: Arizona
city: Denver
country: United States
facility: Denver Nephrology
state: Colorado
city: Minneapolis
country: United States
facility: DaVita Clinical Research
state: Minnesota
Study officials:
affiliation: Ardelyx, Inc.
name: David P Rosenbaum, PhD
role: STUDY_DIRECTOR
References: