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
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.
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.
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