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Patiromer for

Phase 3

Hyperkalemia | Small molecule | Nephrology |Fresenius Medical Care AG|Last Updated: Apr 13, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedPLACEBO_CONTROLLED
Total Trials1
Total Enrollment262
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05136664Trial Evaluating the Efficacy and Safety of Patiromer in Chinese SubjectsPHASE3 COMPLETED 262Feb 10, 2022Nov 18, 2025Apr 13, 202628 China
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Study Endpoints
Primary Endpoints
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 Endpoints
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
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Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Part A: PatiromerEXPERIMENTALPart A: 4-week, single-arm patiromer treatment phase (4 weeks)
Part B: PlaceboPLACEBO_COMPARATORPart B: 8-week randomized, parallel group, placebo-controlled withdrawal phase
Part B: PatiromerEXPERIMENTALPart B: 8-week randomized, parallel group, placebo-controlled withdrawal phase
Interventions
NameTypeDescription
Patiromer Powder for Oral Suspension (Part A)DRUGParticipants 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 (Part B)DRUGPlacebo 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)DRUGParticipants 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.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites28

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 da...

Countries:China
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Competitive Landscape -Hyperkalemia 3 trials