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

NCT02228655 | Terminated Early Phase 1

• 1 other identifier: FX-C-888
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Anemia in Chronic Kidney Disease

Keywords

Chronic Kidney Disease; CKD; Anemia of Chronic Illness

Outcome Measures

Primary Outcomes (1)

• Change in hemoglobin concentration

  57 day evaluation period

Study Arms (1)

FMX-8

OTHER

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

Drug: FMX-8

Interventions

FMX-8 DRUG

FMX-8

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• FerruMax Pharmaceuticals, Inc.: lead

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Related Publications (7)

• 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.

  PMID: 16604073 BACKGROUND

• 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.

  PMID: 17607365 BACKGROUND

• 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.

  PMID: 16075059 BACKGROUND

• 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.

  PMID: 17720528 BACKGROUND

• 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.

  PMID: 21730356 BACKGROUND

• 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.

  PMID: 15758012 BACKGROUND

• 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.

  PMID: 17402808 BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Stewart Lecker, MD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2014
• First Posted: August 29, 2014
• Study Start: October 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: July 1, 2015
• Last Updated: February 2, 2016

Record last verified: 2016-02

Locations

US (1)