Trial Evaluating the Efficacy and Safety of Patiromer in Chinese Subjects

Sponsor
Vifor Fresenius Medical Care Renal Pharma
Study ID
NCT05136664
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Patiromer Powder for Oral Suspension (Part A) — DRUG
    Participants initiate patiromer at an oral dose of 1 packet/day (8.4g/day as powder for suspension). The dose is adjusted ate the following visit based on local serum potassium (sK+) levels. The content of each packet should be mixed with water, apple or cranberry juice before administration.
  • Placebo (Part B) — DRUG
    Placebo is provided in packets, each containing 6 g of placebo as powder for suspension. Participants will take 1 packet per day, by mixing its content with water, apple or cranberry juice.
  • Patiromer Powder for Orals Suspension (Part B) — DRUG
    Participants will continue to receive the same number of packets established during Part A, but dose may be up- or down titrated depending on sK+ levels. The content of each packet should be mixed with water, apple or cranberry juice before administration.

Study Details

This is a multicentre, 2-part, single-blind, randomised, withdrawal, placebo-controlled study, that includes a 4-week patiromer treatment phase (Part A) followed by an 8-week randomised placebo-controlled withdrawal phase (Part B) and a 2-week follow-up period.

Key Dates

Start date
Feb 10, 2022
Status verified
Apr 2026
Primary completion
Nov 18, 2025
Completion
Nov 18, 2025

Study Design

Enrollment
262 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Part A: Patiromer
    Part A: 4-week, single-arm patiromer treatment phase (4 weeks)
  • Placebo Comparator: Part B: Placebo
    Part B: 8-week randomized, parallel group, placebo-controlled withdrawal phase
  • Experimental: Part B: Patiromer
    Part B: 8-week randomized, parallel group, placebo-controlled withdrawal phase

Primary Outcome Measure

Part A: Change from baseline in the serum potassium (sK+) [ Time Frame: Week 4 ]

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