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

NCT07251309 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 420

Last updated 2025-11-26

No results posted yet for this study

Summary

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.

Conditions

  • Hyperkalemia

Interventions

DRUG

WS016

WS016 (12g), oral, three times daily for 48 hours, for a total of six doses.

DRUG

Placebo

Placebo, oral, three times daily for 48 hours, for a total of six doses.

DRUG

WS016

WS016 (6g, 12g or 18g), oral, once daily for 28 consecutive days.

DRUG

Placebo

Placebo, oral, once daily for 28 consecutive days.

DRUG

WS016

WS016, oral, once daily for 11 months, starting at a dose of 12g with subsequent dose adjustments based on serum potassium levels.

Sponsors & Collaborators

  • Waterstone Pharmaceutical (Wuhan) Co., LTD.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-23
Primary Completion
2026-11-30
Completion
2026-11-30

Countries

  • China

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07251309 on ClinicalTrials.gov