A Two-Part, Phase 3 Study Evaluating the Efficacy and Safety of WS016 for the Treatment of Hyperkalemia

Recruiting Phase 3 Interventional Study
Hyperkalemia
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
420 (estimated)
Sponsor
Waterstone Pharmaceutical (Wuhan) Co., LTD. · Industry
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About This Trial

This clinical trial consists of 2 parts, Part A and Part B. Part A consists of a 2-day randomized, double-blind, placebo-controlled corrective phase (CP) and a 28-day randomized, double-blind, placebo-controlled maintenance phase (MP). Part B (open-label extension, OLE) is an open-label, 11-month extension study carried out in participants who come from Part A and meet certain inclusion criteria.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Adults (male or female) aged 18 years and older; * Participants with a serum potassium concentration \>5.0 mmol/L and ≤6.5 mmol/L (serum potassium concentration will be measured using the i-STAT portable biochemical analyzer in screening period); * Participants who have negati…
Contacts

Waterstone Medical Center

+86 27 87531661

mpr2024_waterstone@waterstonepharma.com

CONTACT