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

• ClinicalTrials.gov Identifier: NCT02228655
• Recruitment Status: Terminated
• First Posted: August 29, 2014
• Last Update Posted: February 2, 2016
• Sponsor: FerruMax Pharmaceuticals, Inc.
• Information provided by (Responsible Party): FerruMax Pharmaceuticals, Inc.

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Anemia in Chronic Kidney Disease	Drug: FMX-8	Early Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 2 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Exploratory, Uncontrolled, Open-labeled Trial to Evaluate the Effect of FMX-8 Treatment for Anemia in Patients With Chronic Kidney Disease (CKD), Stage 4 or 5
• Study Start Date: October 2014
• Actual Primary Completion Date: April 2015
• Actual Study Completion Date: July 2015

Arms and Interventions

Arm	Intervention/treatment
FMX-8; FMX-8 for injection, 15mg/kg, twice weekly, 29 days	Drug: FMX-8

Outcome Measures

Primary Outcome Measures :

1. Change in hemoglobin concentration [ Time Frame: 57 day evaluation period ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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:

• 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

Contacts and Locations

Locations

United States, Massachusetts

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States, 02215

Sponsors and Collaborators

FerruMax Pharmaceuticals, Inc.

Investigators

• Principal Investigator: Stewart Lecker, MD; Beth Israel Deaconess Medical Center

More Information

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.

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.

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.

• Responsible Party: FerruMax Pharmaceuticals, Inc.
• ClinicalTrials.gov Identifier: NCT02228655
• Other Study ID Numbers: FX-C-888
• First Posted: August 29, 2014
• Last Update Posted: February 2, 2016
• Last Verified: February 2016

Keywords provided by FerruMax Pharmaceuticals, Inc.:

Chronic Kidney Disease; CKD; Anemia of Chronic Illness

Additional relevant MeSH terms:

Kidney Diseases; Renal Insufficiency, Chronic; Anemia; Hematologic Diseases; Urologic Diseases; Renal Insufficiency