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| ID | Type | Description | Link |
|---|---|---|---|
| CTR20212173 | Registry Identifier | Center for Drug Evaluation (CDE), NMPA |
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| Name | Class |
|---|---|
| Tigermed Consulting Co., Ltd | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: Patiromer | Experimental | Part A: 4-week, single-arm patiromer treatment phase (4 weeks) |
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| Part B: Placebo | Placebo Comparator | Part B: 8-week randomized, parallel group, placebo-controlled withdrawal phase |
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| Part B: Patiromer | Experimental | Part B: 8-week randomized, parallel group, placebo-controlled withdrawal phase |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patiromer Powder for Oral Suspension (Part A) | Drug | 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. |
| 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 |
| Measure | Description | 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Julian Platon, MD, PhD | CSL Vifor | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigator Site 009 | Hefei | Anhui | 230022 | China | ||
| Investigator Site 008 |
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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).
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| Placebo (Part B) | Drug | 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. |
|
| Patiromer Powder for Orals Suspension (Part B) | Drug | 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. |
|
| Part B: Proportion of subjects discontinuing/reducing RAASi medication due to hyperkalemia |
| From Week 4 to 2 weeks after the end of treatment |
| Hefei |
| Anhui |
| 230601 |
| China |
| Investigator Site 016 | Beijing | Beijing Municipality | 100029 | China |
| Investigator Site 012 | Lanzhou | Gansu | 730013 | China |
| Investigator Site 003 | Lanzhou | Gansu | 730030 | China |
| Investigator Site 030 | Nanning | Guangxi | 530000 | China |
| Investigator Site 024 | Nanyang | Henan | 473000 | China |
| Investigator Site 010 | Wuhan | Hubei | 430060 | China |
| Investigator Site 006 | Changsha | Hunan | 410013 | China |
| Investigator Site 002 | Changzhou | Jiangsu | 213004 | China |
| Investigator Site 019 | Nanjing | Jiangsu | 210029 | China |
| Investigator Site 021 | Wuxi | Jiangsu | 214023 | China |
| Investigator Site 005 | Xuzhou | Jiangsu | 221004 | China |
| Investigator Site 013 | Zhenjiang | Jiangsu | 210031 | China |
| Investigator Site 007 | Changchun | Jilin | 130041 | China |
| Investigator Site 018 | Yinchuan | Ningxia | 750003 | China |
| Investigator Site 028 | Shanghai | Pudong New Area | 200120 | China |
| Investigator Site 015 | Shanghai | Shanghai Municipality | 200040 | China |
| Investigator Site 022 | Taiyuan | Shanxi | 030012 | China |
| Investigator Site 011 | Yuncheng | Shanxi | 044099 | China |
| Investigator Site 004 | Chengdu | Sichuan | 610044 | China |
| Investigator Site 014 | Tianjin | Tianjin Municipality | 300052 | China |
| Investigator Site 027 | Zhuzhou | Tianyuan District | 412007 | China |
| Investigator Site 023 | Ürümqi | Xinjiang | 830001 | China |
| Investigator Site 001 | Hangzhou | Zhejiang | 310003 | China |
| Investigator Site 020 | Hanzhou | Zhejiang | 310014 | China |
| Investigator Site 026 | Jiaxing | Zhejiang | 314000 | China |
| Investigator Site 025 | Jinhua | Zhejiang | 322000 | China |
| ID | Term |
|---|---|
| D006947 | Hyperkalemia |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D014883 | Water-Electrolyte Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D013535 | Suspensions |
| ID | Term |
|---|---|
| D003102 | Colloids |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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