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

Sponsor
Waterstone Pharmaceutical (Wuhan) Co., LTD.
Study ID
NCT07251309
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Dec 23, 2024
Status verified
Oct 2025
Primary completion
Nov 30, 2026
Completion
Nov 30, 2026

Study Design

Enrollment
420 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: WS016 (corrective phase)
  • Placebo Comparator: Placebo (corrective phase)
  • Experimental: WS016 (maintenance phase)
  • Placebo Comparator: Placebo (maintenance phase)
  • Experimental: WS016 (open-label extension phase)

Primary Outcome Measure

Mean serum potassium level during maintenance phase Days 8-29 [ Time Frame: Maintenance phase Days 8-29 ]

Central Contacts

Related Studies