Trial Evaluating the Efficacy and Safety of Patiromer in Chinese Subjects (Patiromer JADE)

A 2-Part, Single-Blind, Phase 3 Trial Evaluating the Efficacy and Safety of Patiromer for the Treatment of Hyperkalaemia in Chinese Subjects

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.

Study Overview

• Status: Recruiting
• Conditions: Renal Insufficiency, Chronic; Hyperkalemia
• Intervention / Treatment: Drug: Patiromer Powder for Oral Suspension (Part A); Drug: Placebo (Part B); Drug: Patiromer Powder for Orals Suspension (Part B)

Detailed Description

In Part A, participants who meet all eligibility criteria will initiate patiromer at an oral dose of 8.4 g (1 packet/day). The dose will be adjusted based on the serum potassium (sK+) levels.

After the completion of part A, all the participants who meet the eligibility criteria for Part B will be randomised to receive patiromer or placebo. Participants will start Part B with the same dose of patiromer they were receiving at the end Part A. However, Patiromer dose may be up- or down-titrated based on sK+ levels.

The primary objectives of the study are:

Part A - To evaluate the efficacy of patiromer for the treatment of hyperkalemia in Chinese subjects.

Part B - To evaluate the effect of withdrawing patiromer on sK+ control. To determine if the treatment with patiromer will result in continued use of renin-angiotensin-aldosterone system inhibitor (RAASi) medications.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: PAT-CHINA-303 Clinical Study Team; Phone Number: +41 588 518 000; Email: clinicaltrials@cslbehring.com

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 230601
      • Recruiting
      • Investigator Site 008
    • Hefei, Anhui, China, 230022
      • Withdrawn
      • Investigator Site 009
  • Beijing
    • Beijing, Beijing, China, 100029
      • Recruiting
      • Investigator Site 016
  • Gansu
    • Lanzhou, Gansu, China, 730013
      • Recruiting
      • Investigator Site 012
    • Lanzhou, Gansu, China, 730030
      • Withdrawn
      • Investigator Site 003
  • Henan
    • Nanyang, Henan, China, 473000
      • Recruiting
      • Investigator Site 024
  • Hubei
    • Wuhan, Hubei, China, 430060
      • Recruiting
      • Investigator Site 010
  • Hunan
    • Changsha, Hunan, China, 410013
      • Recruiting
      • Investigator Site 006
  • Jiangsu
    • Changzhou, Jiangsu, China, 213004
      • Recruiting
      • Investigator Site 002
    • Nanjing, Jiangsu, China, 210029
      • Recruiting
      • Investigator Site 019
    • Wuxi, Jiangsu, China, 214023
      • Recruiting
      • Investigator Site 021
    • Xuzhou, Jiangsu, China, 221004
      • Recruiting
      • Investigator Site 005
    • Zhenjiang, Jiangsu, China, 210031
      • Withdrawn
      • Investigator Site 013
  • Jilin
    • Changchun, Jilin, China, 130041
      • Recruiting
      • Investigator Site 007
  • Ningxia
    • Yinchuan, Ningxia, China, 750003
      • Recruiting
      • Investigator Site 018
  • Shanghai
    • Shanghai, Shanghai, China, 200040
      • Recruiting
      • Investigator Site 015
  • Shanxi
    • Taiyuan, Shanxi, China, 030012
      • Recruiting
      • Investigator Site 022
    • Yuncheng, Shanxi, China, 044099
      • Recruiting
      • Investigator Site 011
  • Sichuan
    • Chengdu, Sichuan, China, 610044
      • Recruiting
      • Investigator Site 004
  • Tianjin
    • Tianjin, Tianjin, China, 300052
      • Recruiting
      • Investigator Site 014
  • Xinjiang
    • Ürümqi, Xinjiang, China, 830001
      • Recruiting
      • Investigator Site 023
  • Zhengjiang
    • Hanzhou, Zhengjiang, China, 310014
      • Recruiting
      • Investigator Site 020
  • Zhenjiang
    • Hangzhou, Zhenjiang, China, 310003
      • Recruiting
      • Investigator Site 001

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part A: Patiromer; Part A: 4-week, single-arm patiromer treatment phase (4 weeks)	Drug: Patiromer Powder for Oral Suspension (Part A); 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 Comparator: Part B: Placebo; Part B: 8-week randomized, parallel group, placebo-controlled withdrawal phase	Drug: Placebo (Part B); 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.
Experimental: Part B: Patiromer; Part B: 8-week randomized, parallel group, placebo-controlled withdrawal phase	Drug: Patiromer Powder for Orals Suspension (Part B); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part A: Change from baseline in the serum potassium (sK+)	Measured in milliequivalents per litre (mEq/L)	Week 4
Part B: Change from Week 4 in sK+	Measured in mEq/L	The earlier of: Week 8 or the date when RAASi therapy is first decreased or discontinued

Secondary Outcome Measures

Outcome Measure	Time Frame
Part A: Proportion of participants having an sK+ level between 3.8 and less than 5.1 mEq/L at Week 4	Week 4
Part B: Proportion of participants taking any RAASi medication at Week 12	Week 12
Part B: Proportion of subjects discontinuing/reducing RAASi medication due to hyperkalemia	From Week 4 to 2 weeks after the end of treatment

Collaborators and Investigators

• Sponsor: Vifor Fresenius Medical Care Renal Pharma
• Collaborators: Tigermed Consulting Co., Ltd
• Investigators: Study Director: Julian Platon, MD, PhD, CSL Vifor

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2022
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: November 15, 2021
• First Submitted That Met QC Criteria: November 15, 2021
• First Posted (Actual): November 29, 2021

Study Record Updates

• Last Update Posted (Estimated): April 15, 2024
• Last Update Submitted That Met QC Criteria: April 12, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Chronic kidney disease; Hyperkalemia
• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Kidney Diseases; Urologic Diseases; Disease Attributes; Water-Electrolyte Imbalance; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Hyperkalemia
• Other Study ID Numbers: PAT-CHINA-303; CTR20212173 (Registry Identifier: Center for Drug Evaluation (CDE), NMPA)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No