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patiromer

Phase 2

Hyperkalemia | Small molecule | Cardiovascular |Medpace Holdings, Inc. Common Stock|Last Updated: Jun 2, 2021

Development status

Highest phase Phase 2
Registered trials 1 across 1 sponsor since Mar 2009

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment120

FDA Designations

No designations recorded

Clinical trial landscape

patiromer · 1 trial · 2 indications

Phase 2 1
NCT00868439Evaluation of Patiromer in Heart Failure PatientsHyperkalemia
COMPLETED120 Analytics
PHASE2COMPLETED
Evaluation of Patiromer in Heart Failure Patients
Hyperkalemia
NCT00868439120
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Study Endpoints

Primary Endpoints

Change From Baseline in Serum Potassium to the End of the 28-day Treatment Period.
Baseline and Day 28

Secondary Endpoints

Proportion of Participants With a Serum Potassium Level During the 28-day Treatment Period That Was > 5.5 mEq/L.
28 Days
Proportion of Participants Discontinuing the Study Due to Serum Potassium Elevation (Serum K+ > 5.5 mEq/L).
28 Days
Proportion of Participants Whose Spironolactone Dose Was Increased.
28 Days
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
patiromerACTIVE_COMPARATOR -
placeboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
patiromerDRUGActive investigational drug
placeboDRUGplacebo
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites33

Inclusion Criteria: * Participants with chronic heart failure clinically indicated to receive spironolactone therapy, aged 18 years or older with serum potassium level of 4.3 - 5.1 mEq/L at screening and baseline, AND (1) chronic kidney disease (GFR \< 60 mL/min) OR (2) documented history of hyperk...

Countries:United StatesCzechiaGeorgiaGermanyPolandRussiaUkraine
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Competitive Landscape -Hyperkalemia 3 trials

CompanyTickerTrialsLead PhaseDrugs
AstraZeneca PLCAZN3PHASE3Sodium zirconium cyclosilicate
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