Evaluating Patiromer for Treating High Potassium Levels in Chinese Patients

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)

This study is testing if a medication called patiromer can help Chinese patients with chronic kidney disease lower their high potassium levels and what happens when they stop taking it.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 290 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Vifor Fresenius Medical Care Renal Pharma (industry)
• Locations: 29 sites (Hefei, Anhui and 28 other locations)
• Trial ID: NCT05136664 on ClinicalTrials.gov

What this trial studies

This multicenter, single-blind, randomized, placebo-controlled trial assesses the efficacy and safety of patiromer in Chinese subjects with chronic kidney disease and hyperkalemia. The study consists of two parts: a 4-week treatment phase where participants receive patiromer, followed by an 8-week withdrawal phase where they are randomized to receive either patiromer or a placebo. The primary objectives are to evaluate the effectiveness of patiromer in controlling serum potassium levels and to understand the effects of discontinuing the treatment. Participants' doses will be adjusted based on their serum potassium levels throughout the study.

Who should consider this trial

Good fit: Ideal candidates are Chinese adults aged 18 and older with chronic kidney disease stages 3 and 4 and elevated serum potassium levels.

Not a fit: Patients with severe hyperkalemia requiring emergency intervention or those with recent acute renal insufficiency may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide an effective treatment option for managing hyperkalemia in patients with chronic kidney disease.

How similar studies have performed: Other studies have shown promising results with patiromer in managing hyperkalemia, indicating potential for success in this trial.

Eligibility criteria

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 breastfeeding.

Where this trial is running

Hefei, Anhui and 28 other locations

• Investigator Site 009 — Hefei, Anhui, China (WITHDRAWN)
• Investigator Site 008 — Hefei, Anhui, China (RECRUITING)
• Investigator Site 016 — Beijing, Beijing, China (RECRUITING)
• Investigator Site 012 — Lanzhou, Gansu, China (RECRUITING)
• Investigator Site 003 — Lanzhou, Gansu, China (WITHDRAWN)
• Investigator Site 029 — Guangzhou, Guangdong, China (WITHDRAWN)
• Investigator Site 030 — Nanning, Guangxi, China (RECRUITING)
• Investigator Site 024 — Nanyang, Henan, China (RECRUITING)
• Investigator Site 010 — Wuhan, Hubei, China (RECRUITING)
• Investigator Site 006 — Changsha, Hunan, China (RECRUITING)
• Investigator Site 002 — Changzhou, Jiangsu, China (RECRUITING)
• Investigator Site 019 — Nanjing, Jiangsu, China (RECRUITING)
• Investigator Site 021 — Wuxi, Jiangsu, China (RECRUITING)
• Investigator Site 005 — Xuzhou, Jiangsu, China (RECRUITING)
• Investigator Site 013 — Zhenjiang, Jiangsu, China (WITHDRAWN)
• Investigator Site 007 — Changchun, Jilin, China (RECRUITING)
• Investigator Site 018 — Yinchuan, Ningxia, China (RECRUITING)
• Investigator Site 028 — Shanghai, Pudong New Area, China (RECRUITING)
• Investigator Site 015 — Shanghai, Shanghai, China (RECRUITING)
• Investigator Site 022 — Taiyuan, Shanxi, China (RECRUITING)
• Investigator Site 011 — Yuncheng, Shanxi, China (WITHDRAWN)
• Investigator Site 004 — Chengdu, Sichuan, China (RECRUITING)
• Investigator Site 014 — Tianjin, Tianjin, China (TERMINATED)
• Investigator Site 027 — Zhuzhou, Tianyuan District, China (RECRUITING)
• Investigator Site 023 — Ürümqi, Xinjiang, China (RECRUITING)
• Investigator Site 001 — Hangzhou, Zhejiang, China (RECRUITING)
• Investigator Site 020 — Hanzhou, Zhejiang, China (RECRUITING)
• Investigator Site 026 — Jiaxing, Zhejiang, China (RECRUITING)
• Investigator Site 025 — Jinhua, Zhejiang, China (RECRUITING)

Study contacts

• Study coordinator: PAT-CHINA-303 Clinical Study Team

Conditions: Hyperkalemia, Renal Insufficiency, Chronic, Chronic kidney disease