Clinical trial NCT05136664: Trial Evaluating the Efficacy and Safety of Patiromer in Chinese Subjects
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 (The Patiromer JADE Study)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Hyperkalemia
Renal Insufficiency, Chronic
Keywords: Hyperkalemia
Chronic kidney disease
Lead sponsor: Vifor Fresenius Medical Care Renal Pharma
Sponsor class: INDUSTRY
Collaborators: name: Tigermed Consulting Co., Ltd
First posted: 2021-11-29
Enrollment: 290
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Part A: Change from baseline in the serum potassium (sK+)
timeFrame: Week 4
measure: 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
Secondary outcomes:
measure: Part A: Proportion of participants having an sK+ level between 3.8 and less than 5.1 mEq/L at Week 4
timeFrame: Week 4
measure: Part B: Proportion of participants taking any RAASi medication at Week 12
timeFrame: Week 12
measure: Part B: Proportion of subjects discontinuing/reducing RAASi medication due to hyperkalemia
timeFrame: From Week 4 to 2 weeks after the end of treatment
Other outcomes:
Locations:
city: Hefei
country: China
facility: Investigator Site 009
state: Anhui
city: Hefei
country: China
facility: Investigator Site 008
state: Anhui
city: Beijing
country: China
facility: Investigator Site 016
state: Beijing
city: Lanzhou
country: China
facility: Investigator Site 012
state: Gansu
city: Lanzhou
country: China
facility: Investigator Site 003
state: Gansu
city: Guangzhou
country: China
facility: Investigator Site 029
state: Guangdong
city: Nanning
country: China
facility: Investigator Site 030
state: Guangxi
city: Nanyang
country: China
facility: Investigator Site 024
state: Henan
city: Wuhan
country: China
facility: Investigator Site 010
state: Hubei
city: Changsha
country: China
facility: Investigator Site 006
state: Hunan
city: Changzhou
country: China
facility: Investigator Site 002
state: Jiangsu
city: Nanjing
country: China
facility: Investigator Site 019
state: Jiangsu
city: Wuxi
country: China
facility: Investigator Site 021
state: Jiangsu
city: Xuzhou
country: China
facility: Investigator Site 005
state: Jiangsu
city: Zhenjiang
country: China
facility: Investigator Site 013
state: Jiangsu
city: Changchun
country: China
facility: Investigator Site 007
state: Jilin
city: Yinchuan
country: China
facility: Investigator Site 018
state: Ningxia
city: Shanghai
country: China
facility: Investigator Site 028
state: Pudong New Area
city: Shanghai
country: China
facility: Investigator Site 015
state: Shanghai
city: Taiyuan
country: China
facility: Investigator Site 022
state: Shanxi
city: Yuncheng
country: China
facility: Investigator Site 011
state: Shanxi
city: Chengdu
country: China
facility: Investigator Site 004
state: Sichuan
city: Tianjin
country: China
facility: Investigator Site 014
state: Tianjin
city: Zhuzhou
country: China
facility: Investigator Site 027
state: Tianyuan District
city: Ürümqi
country: China
facility: Investigator Site 023
state: Xinjiang
city: Hangzhou
country: China
facility: Investigator Site 001
state: Zhejiang
city: Hanzhou
country: China
facility: Investigator Site 020
state: Zhejiang
city: Jiaxing
country: China
facility: Investigator Site 026
state: Zhejiang
city: Jinhua
country: China
facility: Investigator Site 025
state: Zhejiang
Study officials:
affiliation: CSL Vifor
name: Julian Platon, MD, PhD
role: STUDY_DIRECTOR
References: