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

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ClinicalTrials.gov Identifier: NCT02228655
Recruitment Status : Terminated (Inability to recruit patients meeting eligibilty criteria.)
First Posted : August 29, 2014
Last Update Posted : February 2, 2016
Sponsor:
Information provided by (Responsible Party):
FerruMax Pharmaceuticals, Inc.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
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

Resource links provided by the National Library of Medicine


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



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


Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02228655


Locations
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United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
FerruMax Pharmaceuticals, Inc.
Investigators
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Principal Investigator: Stewart Lecker, MD Beth Israel Deaconess Medical Center

Publications:
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Responsible Party: FerruMax Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02228655     History of Changes
Other Study ID Numbers: FX-C-888
First Posted: August 29, 2014    Key Record Dates
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:
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Kidney Diseases
Renal Insufficiency, Chronic
Anemia
Hematologic Diseases
Urologic Diseases
Renal Insufficiency