Phase
Condition
Kidney Failure (Pediatric)
Nephropathy
Kidney Disease
Treatment
Patiromer Powder for Orals Suspension (Part B)
Placebo (Part B)
Patiromer Powder for Oral Suspension (Part A)
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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/Lat baseline.
- Subjects on any stable dose of at least 1 RAASi medication for at least 28 daysbefore 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 contraceptionthroughout the study and for 4 weeks after study completion.
Exclusion
Exclusion Criteria:
- Any level of hyperkalemia at Day 0/baseline that, in the opinion of theInvestigator, 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 beginningof the study.
- Diseases affecting the hearth muscle and heart's ability to pump blood around thebody
- Major surgery including thoracic and cardiac within 3 months prior to thebeginning of the study or anticipated need during study participation.
- Heart or kidney transplant recipient or anticipated need for transplant duringstudy 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 priorto Day 0/baseline.
- Pregnant women or breastfeeding.
Study Design
Study Description
Connect with a study center
Investigator Site 008
Hefei, Anhui 230601
ChinaSite Not Available
Investigator Site 009
Hefei, Anhui 230022
ChinaSite Not Available
Investigator Site 008
Hefei 1808722, Anhui 1818058 230601
ChinaSite Not Available
Investigator Site 009
Hefei 1808722, Anhui 1818058 230022
ChinaSite Not Available
Investigator Site 016
Beijing, Beijing Municipality 100029
ChinaSite Not Available
Investigator Site 016
Beijing 1816670, Beijing Municipality 2038349 100029
ChinaSite Not Available
Investigator Site 003
Lanzhou, Gansu 730030
ChinaSite Not Available
Investigator Site 012
Lanzhou, Gansu 730013
ChinaSite Not Available
Investigator Site 003
Lanzhou 1804430, Gansu 1810676 730030
ChinaSite Not Available
Investigator Site 012
Lanzhou 1804430, Gansu 1810676 730013
ChinaSite Not Available
Investigator Site 029
Guangzhou, Guangdong 510060
ChinaSite Not Available
Investigator Site 029
Guangzhou 1809858, Guangdong 1809935 510060
ChinaSite Not Available
Investigator Site 030
Nanning, Guangxi 530000
ChinaSite Not Available
Investigator Site 030
Nanning 1799869, Guangxi 1809867 530000
ChinaSite Not Available
Investigator Site 024
Nanyang, Henan 473000
ChinaSite Not Available
Investigator Site 024
Nanyang 1799629, Henan 1808520 473000
ChinaSite Not Available
Investigator Site 010
Wuhan, Hubei 430060
ChinaSite Not Available
Investigator Site 010
Wuhan 1791247, Hubei 1806949 430060
ChinaSite Not Available
Investigator Site 006
Changsha, Hunan 410013
ChinaSite Not Available
Investigator Site 006
Changsha 1815577, Hunan 1806691 410013
ChinaSite Not Available
Investigator Site 002
Changzhou, Jiangsu 213004
ChinaSite Not Available
Investigator Site 019
Nanjing, Jiangsu 210029
ChinaSite Not Available
Investigator Site 021
Wuxi, Jiangsu 214023
ChinaSite Not Available
Investigator Site 005
Xuzhou, Jiangsu 221004
ChinaSite Not Available
Investigator Site 013
Zhenjiang, Jiangsu 210031
ChinaSite Not Available
Investigator Site 002
Changzhou 1815456, Jiangsu 1806260 213004
ChinaSite Not Available
Investigator Site 019
Nanjing 1799962, Jiangsu 1806260 210029
ChinaSite Not Available
Investigator Site 021
Wuxi 1790923, Jiangsu 1806260 214023
ChinaSite Not Available
Investigator Site 005
Xuzhou 10630003, Jiangsu 1806260 221004
ChinaSite Not Available
Investigator Site 013
Zhenjiang 1784642, Jiangsu 1806260 210031
ChinaSite Not Available
Investigator Site 007
Changchun, Jilin 130041
ChinaSite Not Available
Investigator Site 007
Changchun 2038180, Jilin 2036500 130041
ChinaSite Not Available
Investigator Site 018
Yinchuan, Ningxia 750003
ChinaSite Not Available
Investigator Site 018
Yinchuan 1786657, Ningxia 1799355 750003
ChinaSite Not Available
Investigator Site 028
Shanghai, Pudong New Area 200120
ChinaSite Not Available
Investigator Site 028
Shanghai 1796236, Pudong New Area 200120
ChinaSite Not Available
Investigator Site 015
Shanghai, Shanghai Municipality 200040
ChinaSite Not Available
Investigator Site 015
Shanghai 1796236, Shanghai Municipality 1796231 200040
ChinaSite Not Available
Investigator Site 022
Taiyuan, Shanxi 030012
ChinaSite Not Available
Investigator Site 011
Yuncheng, Shanxi 044099
ChinaSite Not Available
Investigator Site 022
Taiyuan 1793511, Shanxi 1795912 030012
ChinaSite Not Available
Investigator Site 011
Yuncheng 1785738, Shanxi 1795912 044099
ChinaSite Not Available
Investigator Site 004
Chengdu, Sichuan 610044
ChinaSite Not Available
Investigator Site 004
Chengdu 1815286, Sichuan 1794299 610044
ChinaSite Not Available
Investigator Site 014
Tianjin, Tianjin Municipality 300052
ChinaSite Not Available
Investigator Site 014
Tianjin 1792947, Tianjin Municipality 1792943 300052
ChinaSite Not Available
Investigator Site 027
Zhuzhou, Tianyuan District 412007
ChinaSite Not Available
Investigator Site 027
Zhuzhou 1783763, Tianyuan District 412007
ChinaSite Not Available
Investigator Site 023
Ürümqi, Xinjiang 830001
ChinaSite Not Available
Investigator Site 023
Ürümqi 1529102, Xinjiang 1529047 830001
ChinaSite Not Available
Investigator Site 001
Hangzhou, Zhejiang 310003
ChinaSite Not Available
Investigator Site 020
Hanzhou, Zhejiang 310014
ChinaSite Not Available
Investigator Site 026
Jiaxing, Zhejiang 314000
ChinaSite Not Available
Investigator Site 025
Jinhua, Zhejiang 322000
ChinaSite Not Available
Investigator Site 001
Hangzhou 1808926, Zhejiang 1784764 310003
ChinaSite Not Available
Investigator Site 026
Jiaxing 1805953, Zhejiang 1784764 314000
ChinaSite Not Available
Investigator Site 025
Jinhua 1805528, Zhejiang 1784764 322000
ChinaSite Not Available

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