An Exploratory Study to Evaluate FMX-8 to Treat Anemia in CKD
NCT ID: NCT02228655
Last Updated: 2016-02-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
EARLY_PHASE1
2 participants
INTERVENTIONAL
2014-10-31
2015-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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FMX-8
FMX-8 for injection, 15mg/kg, twice weekly, 29 days
FMX-8
Interventions
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FMX-8
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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FerruMax Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Stewart Lecker, MD
Role: PRINCIPAL_INVESTIGATOR
Beth Israel Deaconess Medical Center
Locations
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Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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FX-C-888
Identifier Type: -
Identifier Source: org_study_id
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