Health TrialsbyHealthPanel

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

ConditionHyperkalemia
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorWaterstone Pharmaceutical (Wuhan) Co., LTD.

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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 negative pregnancy test result at screening and ensure the use of contraception during the trial;

Participants who understand and voluntarily sign the Informed Consent Form.

Disqualifiers

Participants who have a history of severe drug allergy, or are definitely allergic to the investigational product or its ingredients;

Participants who have pseudohyperkalemia, such as serum potassium increasing caused by hemolysis of blood samples due to improper blood collection methods (such as too tight pressure pulse band banding, too heavy local rubbing, repeated fist clenching-loosening hands), hemolysis of blood samples due to difficulty in venipuncture or trauma, and severe leukocytosis (>50 × 10^9/L) or thrombocytosis (>500 × 10^9/L);

Participants with acute hyperkalemia caused by conditions such as tumor lysis syndrome or hemolysis and so on;

Participants suffering from severe cerebrovascular diseases, such as cerebral infarction or cerebral hemorrhagic disease, with language disorder or unresponsiveness, or severely blocked limb movement;

Trial design

Design model

Parallel

Treatments tested in this trial

  • WS016

    Drug

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

  • Placebo

    Drug

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

  • WS016

    Drug

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

  • Placebo

    Drug

    Placebo, oral, once daily for 28 consecutive days.

  • WS016

    Drug

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

Treatment groups

420 Participants
are divided into 5 treatment groups
Group A: WS016 (corrective phase)Experimental treatment 1 intervention
Group B: Placebo (corrective phase)Placebo comparator 1 intervention
Group C: WS016 (maintenance phase)Experimental treatment 1 intervention
Group D: Placebo (maintenance phase)Placebo comparator 1 intervention
Group E: WS016 (open-label extension phase)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Mean serum potassium level during maintenance phase Days 8-29

Time frame
Maintenance phase Days 8-29

Secondary outcomes

1

Exponential rate of change in serum potassium during the corrective phase

Time frame
Through 48 hours corrective phase
2

Mean change from baseline in serum potassium at all time points of corrective phase

Time frame
Through 48 hours corrective phase
3

Cumulative duration (in days) of serum potassium within the normal range during the maintenance phase

Time frame
Maintenance phase baseline to maintenance phase Day 29
4

Mean change from baseline in serum potassium at all time points of maintenance phase

Time frame
Through 28 days maintenance phase

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Waterstone Pharmaceutical (Wuhan) Co., LTD.

Lead sponsor

Source ClinicalTrials.gov
Apply now