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

Ardelyx

Status and phase: Completed; Phase 2

Conditions: ESRD; End Stage Renal Disease; Chronic Kidney Disease Stage 5

Treatments: Drug: Placebo; Drug: AZD1722 (in-patient); Drug: AZD1722 (out-patient); Drug: Placebo (in-patient)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01764854

D5611C00001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 88 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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88 participants in 4 patient groups, including a placebo group

AZD1722- in patient

Experimental group

Description:

Tenapanor administered in a clinical pharmacology unit

Treatment:

Drug: AZD1722 (in-patient)

Placebo- in patient

Placebo Comparator group

Description:

Placebo (size and color matched to experimental drug) administered in a clinical pharmacology unit

Treatment:

Drug: Placebo (in-patient)

AZD1722 out-patient

Experimental group

Description:

Tenapanor

Treatment:

Drug: AZD1722 (out-patient)

Placebo out-patient

Experimental group

Description:

Placebo

Treatment:

Drug: Placebo