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

Primary Purpose

Anemia in Chronic Kidney Disease

Status
Terminated
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
FMX-8
Sponsored by
FerruMax Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anemia in Chronic Kidney Disease focused on measuring Chronic Kidney Disease, CKD, Anemia of Chronic Illness

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Beth Israel Deaconess Medical Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

FMX-8

Arm Description

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

Outcomes

Primary Outcome Measures

Change in hemoglobin concentration

Secondary Outcome Measures

Full Information

First Posted
July 17, 2014
Last Updated
February 1, 2016
Sponsor
FerruMax Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02228655
Brief Title
An Exploratory Study to Evaluate FMX-8 to Treat Anemia in CKD
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 Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Terminated
Why Stopped
Inability to recruit patients meeting eligibilty criteria.
Study Start Date
October 2014 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
FerruMax Pharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia in Chronic Kidney Disease
Keywords
Chronic Kidney Disease, CKD, Anemia of Chronic Illness

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FMX-8
Arm Type
Other
Arm Description
FMX-8 for injection, 15mg/kg, twice weekly, 29 days
Intervention Type
Drug
Intervention Name(s)
FMX-8
Primary Outcome Measure Information:
Title
Change in hemoglobin concentration
Time Frame
57 day evaluation period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stewart Lecker, MD
Organizational Affiliation
Beth Israel Deaconess Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16604073
Citation
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.
Results Reference
background
PubMed Identifier
17607365
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. doi: 10.1172/JCI31342.
Results Reference
background
PubMed Identifier
16075059
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. doi: 10.1172/JCI25049.
Results Reference
background
PubMed Identifier
17720528
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. doi: 10.1053/j.ajkd.2007.06.008. No abstract available.
Results Reference
background
PubMed Identifier
21730356
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.
Results Reference
background
PubMed Identifier
15758012
Citation
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.
Results Reference
background
PubMed Identifier
17402808
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. doi: 10.18553/jmcp.2007.13.s3.1.
Results Reference
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An Exploratory Study to Evaluate FMX-8 to Treat Anemia in CKD

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