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

Sponsor

Vifor Fresenius Medical Care Renal Pharma (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05136664

Collaborator

Tigermed Consulting Co., Ltd (Industry)

200

Enrollment

Locations

Arms

24.6

Anticipated Duration (Months)

9.1

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hyperkalemia Renal Insufficiency, Chronic	Drug: Patiromer Powder for Oral Suspension (Part A) Drug: Placebo (Part B) Drug: Patiromer Powder for Orals Suspension (Part B)	Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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).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:

Single (Participant)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Feb 10, 2022

Anticipated Primary Completion Date :

Mar 1, 2024

Anticipated Study Completion Date :

Mar 1, 2024

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Investigator Site 009	Hefei	Anhui	China	230022
2	Investigator Site 008	Hefei	Anhui	China	230601
3	Investigator Site 016	Beijing	Beijing	China	100029
4	Investigator Site 012	Lanzhou	Gansu	China	730013
5	Investigator Site 003	Lanzhou	Gansu	China	730030
6	Investigator Site 010	Wuhan	Hubei	China	430060
7	Investigator Site 006	Changsha	Hunan	China	410013
8	Investigator Site 002	Changzhou	Jiangsu	China	213004
9	Investigator Site 019	Nanjing	Jiangsu	China	210029
10	Investigator Site 021	Wuxi	Jiangsu	China	214023
11	Investigator Site 005	Xuzhou	Jiangsu	China	221004
12	Investigator Site 013	Zhenjiang	Jiangsu	China	210031
13	Investigator Site 007	Changchun	Jilin	China	130041
14	Investigator Site 018	Yinchuan	Ningxia	China	750003
15	Investigator Site 015	Shanghai	Shanghai	China	200040
16	Investigator Site 022	Taiyuan	Shanxi	China	030012
17	Investigator Site 011	Yuncheng	Shanxi	China	044099
18	Investigator Site 004	Chengdu	Sichuan	China	610044
19	Investigator Site 014	Tianjin	Tianjin	China	300052
20	Investigator Site 023	Ürümqi	Xinjiang	China	830001
21	Investigator Site 020	Hanzhou	Zhengjiang	China	310014
22	Investigator Site 001	Hangzhou	Zhenjiang	China	310003

Sponsors and Collaborators

Vifor Fresenius Medical Care Renal Pharma
Tigermed Consulting Co., Ltd

Investigators

Study Director: Julian Platon, MD, PhD, Vifor Pharma Group

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Vifor Fresenius Medical Care Renal Pharma

ClinicalTrials.gov Identifier:

NCT05136664

Other Study ID Numbers:

PAT-CHINA-303
CTR20212173

First Posted:

Nov 29, 2021

Last Update Posted:

Apr 5, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Vifor Fresenius Medical Care Renal Pharma

Hyperkalemia

Chronic kidney disease

Additional relevant MeSH terms:

Renal Insufficiency

Renal Insufficiency, Chronic

Hyperkalemia

Study Results

No Results Posted as of Apr 5, 2022