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TerminatedNCT02228655Updated Feb 2, 2016

An Exploratory Study to Evaluate FMX-8 to Treat Anemia in CKD

An Early Phase 1 interventional study of FMX-8 in Anemia in Chronic Kidney Disease, sponsored by FerruMax Pharmaceuticals, Inc.. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-02-02.

Sponsored by FerruMax Pharmaceuticals, Inc. · Early Phase 1, Interventional, and Treatment

Why this study was terminated
Inability to recruit patients meeting eligibilty criteria.
Phase
Early Phase 1
Study type
Interventional
Enrollment
2
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

FMX-8 is a new type of drug being tested for the treatment of anemia in chronic illnesses.

02

Conditions studied

  • Anemia in Chronic Kidney Disease

Keywords

  • Chronic Kidney Disease
  • CKD
  • Anemia of Chronic Illness
03

In context

Kidney Diseases

3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.

This study's enrollment of 2 is below the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.

Browse Kidney Diseases studies →

Lead sponsor

FerruMax Pharmaceuticals, Inc. is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • a documented hemoglobin level to be less than 10 g/dL at screening
  • diagnoses of CKD 4 or 5
  • body mass index (BMI) between 18 kg/m2 and 42 kg/m2, inclusive, based upon the height and weight at screening
  • ferritin levels ≥100 ng/ml or Tsat ≥20% at screening
  • erythropoietin (EPO) level greater than 8 ng/mL
  • able to provide written informed consent
  • able to understand and follow all trial procedures
  • willing to use contraception as detailed in the protocol

Exclusion criteria

Exclusion Criteria:

  • receipt of red blood cell (RBC) transfusion within four weeks before screening
  • overt gastrointestinal bleeding or other bleeding episode that required transfusion within 2 months prior to screening
  • infection necessitating antibiotic or anti-viral treatment within a month prior to screening
  • requiring Coumadin (warfarin), Pradaxa®, Eliquis®, or Xarelto®
  • hemoglobinopathies such as homozygous sickle-cell disease or thalassemias of all types
  • active hemolysis or chronic hypoxia
  • active malignant diseases (except non-melanoma skin cancer) or life expectancy less than 6 months
  • chronic, uncontrolled or symptomatic inflammatory disease or non-renal cause of anemia such as rheumatoid arthritis, systemic lupus erythematosus, HIV, or systemic acute infection
  • on immunosuppressive therapeutics except topical corticosteroids or nasal sprays
  • chronic congestive heart failure (New York Heart Association Class III, IV)
  • significant hypertension (≥90 diastolic) based on a sitting diastolic blood pressure at screening
  • kidney transplant within the past year: patients who are off immunosuppressive agents following a failed transplant are eligible for the trial
  • end-stage liver disease
  • known hypersensitivity to recombinant protein therapies
  • female patients who are pregnant or breast feeding
  • previous exposure to FMX-8
  • previous exposure to Epogen®, Procrit® (erythropoietin) Aranesp® (darbepoietin alpha), Omontys® or Hematide® (peginesatide) anemia treatment
  • uncontrolled hyperparathyroidism (PTH >750) based upon latest PTH determination within the past 4 months
  • inability to comply with the trial scheduled visits
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Study design

Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
2 participants (actual)

Study arms

  • Other
    FMX-8

    FMX-8 for injection, 15mg/kg, twice weekly, 29 days

    Drug: FMX-8

Interventions

  • DrugFMX-8
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What researchers measure

Primary outcomes

  1. Change in hemoglobin concentration

    Time frame: 57 day evaluation period

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Study locations

1 site
  • Beth Israel Deaconess Medical Center
    Boston, Massachusetts 02215, United States
08

References and documents

Publications

  • Babitt JL, Huang FW, Wrighting DM, Xia Y, Sidis Y, Samad TA, Campagna JA, Chung RT, Schneyer AL, Woolf CJ, Andrews NC, Lin HY. Bone morphogenetic protein signaling by hemojuvelin regulates hepcidin expression. Nat Genet. 2006 May;38(5):531-9. doi: 10.1038/ng1777. Epub 2006 Apr 9. PubMed 16604073 ↗
  • Babitt JL, Huang FW, Xia Y, Sidis Y, Andrews NC, Lin HY. Modulation of bone morphogenetic protein signaling in vivo regulates systemic iron balance. J Clin Invest. 2007 Jul;117(7):1933-9. doi: 10.1172/JCI31342. PubMed 17607365 ↗
  • Huang FW, Pinkus JL, Pinkus GS, Fleming MD, Andrews NC. A mouse model of juvenile hemochromatosis. J Clin Invest. 2005 Aug;115(8):2187-91. doi: 10.1172/JCI25049. PubMed 16075059 ↗
  • KDOQI. KDOQI Clinical Practice Guideline and Clinical Practice Recommendations for anemia in chronic kidney disease: 2007 update of hemoglobin target. Am J Kidney Dis. 2007 Sep;50(3):471-530. doi: 10.1053/j.ajkd.2007.06.008. No abstract available. PubMed 17720528 ↗
  • Theurl I, Schroll A, Sonnweber T, Nairz M, Theurl M, Willenbacher W, Eller K, Wolf D, Seifert M, Sun CC, Babitt JL, Hong CC, Menhall T, Gearing P, Lin HY, Weiss G. Pharmacologic inhibition of hepcidin expression reverses anemia of chronic inflammation in rats. Blood. 2011 Nov 3;118(18):4977-84. doi: 10.1182/blood-2011-03-345066. Epub 2011 Jul 5. PubMed 21730356 ↗
  • Weiss G, Goodnough LT. Anemia of chronic disease. N Engl J Med. 2005 Mar 10;352(10):1011-23. doi: 10.1056/NEJMra041809. No abstract available. PubMed 15758012 ↗
  • Weiner DE. Causes and consequences of chronic kidney disease: implications for managed health care. J Manag Care Pharm. 2007 Apr;13(3 Suppl):S1-9. doi: 10.18553/jmcp.2007.13.s3.1. PubMed 17402808 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 2, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02228655
Lead sponsor
FerruMax Pharmaceuticals, Inc.
Responsible party
Sponsor
First posted
Aug 29, 2014
Start date
Oct 2014
Primary completion
Apr 2015
Completion
Jul 2015
Last update
Feb 2, 2016

Study contacts

Stewart Lecker, MD
principal investigator · Beth Israel Deaconess Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.

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