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KRX-0502

Phase 4FDA approved 2014

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

KRX-0502 development status

FDA approval Sep 5, 2014 as Auryxia
Approval holderKeryx Biopharms
ApplicationNDA205874
Highest phase Phase 4 (NCT03236246)
Phase scored for AKBAPhase 2
Registered trials 18 across 8 sponsors since Apr 2008

Label indication Ferric citrate tablets are a phosphate binder indicated for the control of serum phosphorus levels in adult patients with chronic kidney disease on dialysis. ( 1 ) Ferric citrate tablets are an iron replacement product indicated for the treatment of iron deficiency anemia in adult patients with chronic kidney disease not on dialysis. FDA label

KRX-0502 target and mechanism

ModalitySmall molecule

Also known as ferric citrate, Auryxia, PhosLo, Renvela, Zerenex

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment32

FDA Designations

No designations recorded

KRX-0502 clinical trials

KRX-0502 · 1 trial · 1 indication

Phase 2 1
NCT02128074A Pilot Study of KRX-0502 (Ferric Citrate, Administered Without Food, in Treating Iron-deficiency AnemiaAnemia of Chronic Kidney Disease
COMPLETED32 Analytics
PHASE2COMPLETED
A Pilot Study of KRX-0502 (Ferric Citrate, Administered Without Food, in Treating Iron-deficiency Anemia
Anemia of Chronic Kidney DiseaseUnlock trial analytics

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 to 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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Frequently asked questions about KRX-0502

What is KRX-0502?

KRX-0502 is an investigational small molecule developed by Akebia Therapeutics, Inc. for anemia of chronic kidney disease. It was studied as ferric citrate administered without food to treat iron-deficiency anemia in adults with chronic kidney disease. It is a Phase 2 candidate and is not approved for marketing.

What is KRX-0502 used for in anemia of chronic kidney disease?

KRX-0502 was studied for the treatment of iron-deficiency anemia in adults with anemia of chronic kidney disease. The pilot study enrolled adults aged 18 years and older and evaluated ferric citrate given without food. The program is in Phase 2 development and no approved use has been established.

Who makes KRX-0502?

KRX-0502 is developed by Akebia Therapeutics, Inc., which trades on the Nasdaq under the ticker AKBA. Akebia is the sponsor of the clinical program evaluating the candidate in anemia of chronic kidney disease.

What phase is KRX-0502 in?

KRX-0502 is in Phase 2 development. Its single recorded trial, NCT02128074, is a completed Phase 2 pilot study. The drug is investigational and has not been approved by the FDA for any indication.

What clinical trials is KRX-0502 in?

KRX-0502 has been evaluated in one clinical trial, NCT02128074, titled a pilot study of KRX-0502 (ferric citrate) administered without food in treating iron-deficiency anemia. That Phase 2 trial is completed, enrolled 32 participants, and was conducted in Israel. It was an uncontrolled study without randomization or blinding.

Is KRX-0502 the same as ferric citrate?

KRX-0502 is ferric citrate. The Phase 2 pilot trial NCT02128074 describes the study drug as KRX-0502 (ferric citrate) administered without food in treating iron-deficiency anemia in patients with anemia of chronic kidney disease.