NCT05136664CompletedPhase 3
Trial Evaluating the Efficacy and Safety of Patiromer in Chinese Subjects
A 2-Part, Single-Blind, Phase 3 Trial Evaluating the Efficacy and Safety of Patiromer for the Treatment of Hyperkalaemia in Chinese Subjects (The Patiromer JADE Study)
Source: ClinicalTrials.gov · Last updated 13 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 262 (actual)
- First submitted
- 15 Nov 2021
- Start date
- 10 Feb 2022
- Primary completion date
- 18 Nov 2025
- Lead sponsor
- Vifor Fresenius Medical Care Renal Pharma
- Diseases
- Chronic kidney disease
- NCT number
- NCT05136664
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 262
- From 10 Feb 2022 to the primary completion date, 18 Nov 2025
- 28 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- \- History of acute renal insufficiency in the past 3 months prior to the beginning of the study.
- \- Major surgery including thoracic and cardiac within 3 months prior to the beginning of the study or anticipated need during study participation.
Other illness
- \- Diseases affecting the hearth muscle and heart's ability to pump blood around the body
- \- 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.
Lab values
- \- Type 1 diabetes or Type 2 diabetes mellitus with glycated haemoglobin (Hb A1c) higher than 10.0% at screening/Part A baseline.
- \- Use of potassium supplements, bicarbonate or baking soda in the last 7 days prior to Day 0/baseline.
Other
- \- Any level of hyperkalemia at Day 0/baseline that, in the opinion of the Investigator, requires emergency intervention.
- \- Pregnant women or breastfeeding.
Who the study is looking for
- \- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (28)
Sites in registry order. Pick your city on the disease page to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.