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

Primary Purpose

Hyperkalemia, Renal Insufficiency, Chronic

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Patiromer Powder for Oral Suspension (Part A)
Placebo (Part B)
Patiromer Powder for Orals Suspension (Part B)
Sponsored by
Vifor Fresenius Medical Care Renal Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperkalemia focused on measuring Hyperkalemia, Chronic kidney disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Investigator Site 009Recruiting
  • Investigator Site 008Recruiting
  • Investigator Site 016Recruiting
  • Investigator Site 012Recruiting
  • Investigator Site 003Recruiting
  • Investigator Site 010Recruiting
  • Investigator Site 006Recruiting
  • Investigator Site 002Recruiting
  • Investigator Site 019Recruiting
  • Investigator Site 021Recruiting
  • Investigator Site 005Recruiting
  • Investigator Site 013Recruiting
  • Investigator Site 007Recruiting
  • Investigator Site 018Recruiting
  • Investigator Site 015Recruiting
  • Investigator Site 022Recruiting
  • Investigator Site 011Recruiting
  • Investigator Site 004Recruiting
  • Investigator Site 014Recruiting
  • Investigator Site 023Recruiting
  • Investigator Site 020Recruiting
  • Investigator Site 001Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Experimental

Arm Label

Part A: Patiromer

Part B: Placebo

Part B: Patiromer

Arm Description

Part A: 4-week, single-arm patiromer treatment phase (4 weeks)

Part B: 8-week randomized, parallel group, placebo-controlled withdrawal phase

Part B: 8-week randomized, parallel group, placebo-controlled withdrawal phase

Outcomes

Primary Outcome Measures

Part A: Change from baseline in the serum potassium (sK+)
Measured in milliequivalents per litre (mEq/L)
Part B: Change from Week 4 in sK+
Measured in mEq/L

Secondary Outcome Measures

Part A: Proportion of participants having an sK+ level between 3.8 and less than 5.1 mEq/L at Week 4
Part B: Proportion of participants taking any RAASi medication at Week 12
Part B: Proportion of subjects discontinuing/reducing RAASi medication due to hyperkalemia

Full Information

First Posted
November 15, 2021
Last Updated
September 15, 2022
Sponsor
Vifor Fresenius Medical Care Renal Pharma
Collaborators
Tigermed Consulting Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT05136664
Brief Title
Trial Evaluating the Efficacy and Safety of Patiromer in Chinese Subjects
Acronym
Patiromer JADE
Official Title
A 2-Part, Single-Blind, Phase 3 Trial Evaluating the Efficacy and Safety of Patiromer for the Treatment of Hyperkalaemia in Chinese Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 10, 2022 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vifor Fresenius Medical Care Renal Pharma
Collaborators
Tigermed Consulting Co., Ltd

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperkalemia, Renal Insufficiency, Chronic
Keywords
Hyperkalemia, Chronic kidney disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
2-part, single-blind, randomised withdrawal, placebo-controlled (Part B), parallel group study that includes a 4-week patiromer treatment phase (Part A) followed by an 8-week randomised placebo-controlled withdrawal phase (Part B).
Masking
Participant
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Part A: Patiromer
Arm Type
Experimental
Arm Description
Part A: 4-week, single-arm patiromer treatment phase (4 weeks)
Arm Title
Part B: Placebo
Arm Type
Placebo Comparator
Arm Description
Part B: 8-week randomized, parallel group, placebo-controlled withdrawal phase
Arm Title
Part B: Patiromer
Arm Type
Experimental
Arm Description
Part B: 8-week randomized, parallel group, placebo-controlled withdrawal phase
Intervention Type
Drug
Intervention Name(s)
Patiromer Powder for Oral Suspension (Part A)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo (Part B)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Patiromer Powder for Orals Suspension (Part B)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Part A: Change from baseline in the serum potassium (sK+)
Description
Measured in milliequivalents per litre (mEq/L)
Time Frame
Week 4
Title
Part B: Change from Week 4 in sK+
Description
Measured in mEq/L
Time Frame
The earlier of: Week 8 or the date when RAASi therapy is first decreased or discontinued
Secondary Outcome Measure Information:
Title
Part A: Proportion of participants having an sK+ level between 3.8 and less than 5.1 mEq/L at Week 4
Time Frame
Week 4
Title
Part B: Proportion of participants taking any RAASi medication at Week 12
Time Frame
Week 12
Title
Part B: Proportion of subjects discontinuing/reducing RAASi medication due to hyperkalemia
Time Frame
From Week 4 to 2 weeks after the end of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
PAT-CHINA-303 Clinical Study Team
Phone
+41 588 518 000
Email
pat-china-303.study@viforpharma.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Grégory Aubert, MD, PhD
Organizational Affiliation
CSL Vifor
Official's Role
Study Director
Facility Information:
Facility Name
Investigator Site 009
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230022
Country
China
Individual Site Status
Recruiting
Facility Name
Investigator Site 008
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230601
Country
China
Individual Site Status
Recruiting
Facility Name
Investigator Site 016
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100029
Country
China
Individual Site Status
Recruiting
Facility Name
Investigator Site 012
City
Lanzhou
State/Province
Gansu
ZIP/Postal Code
730013
Country
China
Individual Site Status
Recruiting
Facility Name
Investigator Site 003
City
Lanzhou
State/Province
Gansu
ZIP/Postal Code
730030
Country
China
Individual Site Status
Recruiting
Facility Name
Investigator Site 010
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430060
Country
China
Individual Site Status
Recruiting
Facility Name
Investigator Site 006
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410013
Country
China
Individual Site Status
Recruiting
Facility Name
Investigator Site 002
City
Changzhou
State/Province
Jiangsu
ZIP/Postal Code
213004
Country
China
Individual Site Status
Recruiting
Facility Name
Investigator Site 019
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
Individual Site Status
Recruiting
Facility Name
Investigator Site 021
City
Wuxi
State/Province
Jiangsu
ZIP/Postal Code
214023
Country
China
Individual Site Status
Recruiting
Facility Name
Investigator Site 005
City
Xuzhou
State/Province
Jiangsu
ZIP/Postal Code
221004
Country
China
Individual Site Status
Recruiting
Facility Name
Investigator Site 013
City
Zhenjiang
State/Province
Jiangsu
ZIP/Postal Code
210031
Country
China
Individual Site Status
Recruiting
Facility Name
Investigator Site 007
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130041
Country
China
Individual Site Status
Recruiting
Facility Name
Investigator Site 018
City
Yinchuan
State/Province
Ningxia
ZIP/Postal Code
750003
Country
China
Individual Site Status
Recruiting
Facility Name
Investigator Site 015
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200040
Country
China
Individual Site Status
Recruiting
Facility Name
Investigator Site 022
City
Taiyuan
State/Province
Shanxi
ZIP/Postal Code
030012
Country
China
Individual Site Status
Recruiting
Facility Name
Investigator Site 011
City
Yuncheng
State/Province
Shanxi
ZIP/Postal Code
044099
Country
China
Individual Site Status
Recruiting
Facility Name
Investigator Site 004
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610044
Country
China
Individual Site Status
Recruiting
Facility Name
Investigator Site 014
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300052
Country
China
Individual Site Status
Recruiting
Facility Name
Investigator Site 023
City
Ürümqi
State/Province
Xinjiang
ZIP/Postal Code
830001
Country
China
Individual Site Status
Recruiting
Facility Name
Investigator Site 020
City
Hanzhou
State/Province
Zhengjiang
ZIP/Postal Code
310014
Country
China
Individual Site Status
Recruiting
Facility Name
Investigator Site 001
City
Hangzhou
State/Province
Zhenjiang
ZIP/Postal Code
310003
Country
China
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Trial Evaluating the Efficacy and Safety of Patiromer in Chinese Subjects

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