Conditions: End Stage Renal Disease Chronic Kidney Disease Stage 5 ESRD
Keywords: Hemodialysis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 88
Healthy volunteers: no

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.

Arms:
arm 1: Tenapanor administered in a clinical pharmacology unit arm 2: Placebo (size and color matched to experimental drug) administered in a clinical pharmacology unit arm 3: Tenapanor arm 4: Placebo

Interventions: intervention 1: AZD1722 (in-patient) intervention 2: Placebo (in-patient) intervention 3: AZD1722 (out-patient) intervention 4: Placebo
Intervention descriptions: intervention 1: doses between 5 and 60 mg BID may be administered based on tolerability in a CPU setting intervention 2: Placebo, size and color matched to experimental drug administered in a CPU intervention 3: doses between 5 and 45 mg BID intervention 4: Placebo, size and color matched to experimental drug

Protocol document: