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

Anemia in Chronic Kidney Disease Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02228655
• Other study ID #: FX-C-888
• Status: Terminated
• Phase: Phase 0
• First received: July 17, 2014
• Last updated: February 1, 2016
• Start date: October 2014
• Est. completion date: July 2015

Study information

• Verified date: February 2016
• Source: FerruMax Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: July 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia
• Anemia in Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• FMX-8

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
FerruMax Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

References & 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. Epub 2006 Apr 9. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

Weiss G, Goodnough LT. Anemia of chronic disease. N Engl J Med. 2005 Mar 10;352(10):1011-23. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in hemoglobin concentration		57 day evaluation period	No