Trial Evaluating the Efficacy and Safety of Patiromer in Chinese Subjects (NCT05136664) | Clinical Trial Compass
CompletedPhase 3
Trial Evaluating the Efficacy and Safety of Patiromer in Chinese Subjects
China262 participantsStarted 2022-02-10
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* \- Chinese subjects at least 18 years of age.
* \- Chronic Kidney Disease (CKD) stage 3 and 4.
* \- Mean of 2 measurement of serum potassium higher than 5.0 and lower than 6.5 mEq/L at baseline.
* \- Subjects on any stable dose of at least 1 RAASi medication for at least 28 days before Day 0/baseline.
* \- If on antihypertensive medication, have a stable dose for 28 days before Day 0/baseline.
* \- Women of childbearing potential must agree to continue using contraception throughout the study and for 4 weeks after study completion.
Exclusion Criteria:
* \- Any level of hyperkalemia at Day 0/baseline that, in the opinion of the Investigator, requires emergency intervention.
* \- Type 1 diabetes or Type 2 diabetes mellitus with glycated haemoglobin (Hb A1c) higher than 10.0% at screening/Part A baseline.
* \- History of acute renal insufficiency in the past 3 months prior to the beginning of the study.
* \- Diseases affecting the hearth muscle and heart's ability to pump blood around the body
* \- Major surgery including thoracic and cardiac within 3 months prior to the beginning of the study or anticipated need during study participation.
* \- Heart or kidney transplant recipient or anticipated need for transplant during study participation
* \- Diagnosis or treatment of a malignancy in the past 2 years before Day 0/baseline.
* \- Use of potassium supplements, bicarbonate or baking soda in the last 7 days prior to Day 0/baseline.
* \- Pregnant women or…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Part A: Change from baseline in the serum potassium (sK+)
Timeframe: Week 4
2
Part B: Change from Week 4 in sK+
Timeframe: The earlier of: Week 8 or the date when RAASi therapy is first decreased or discontinued