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KRX-0502

Phase 2

Anemia of Chronic Kidney Disease | Small molecule | Hematology |Akebia Therapeutics, Inc.|Last Updated: Aug 24, 2018

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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment32
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02128074A Pilot Study of KRX-0502 (Ferric Citrate, Administered Without Food, in Treating Iron-deficiency AnemiaPHASE2 COMPLETED 32Apr 1, 2014Nov 1, 2014Aug 24, 20183 Israel
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Study Endpoints
Primary Endpoints
Change in Hemoglobin From Baseline to the End of 8-week Treatment Period
8 weeks
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
KRX-0502EXPERIMENTALKRX-0502 (ferric citrate)
Interventions
NameTypeDescription
KRX-0502DRUG1g tablets of KRX-0502
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * Males and non-lactating females with negative serum pregnancy test (for females of child-bearing potential) at Screening * Age ≥ 18 years * Serum ferritin ≤ 300 ng/mL and TSAT ≤ 25% at Screening * Hemoglobin ≥9.0 g/dL and ≤11.5 g/dL at Screening * eGFR \<60 mL/min at Screening...

Countries:Israel
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