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

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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

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

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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