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A Phase 2A Trial of FMX-8 Treatment for Anemia in Patients With ESRD on Hemodialysis HD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01873534
Recruitment Status : Terminated (Unable to recruit patients meeting the inclusion criteria)
First Posted : June 10, 2013
Last Update Posted : August 11, 2015
Davita Clinical Research
Information provided by (Responsible Party):
FerruMax Pharmaceuticals, Inc.

Brief Summary:
The trial is an uncontrolled, open-label, parallel group clinical trial. Approximately 10 subjects per dose group in 3 groups will be treated twice weekly for a total of 9 doses, followed by a 4-week observation period. Eligible subjects who have Hgb ≥10.5 g/dL and have stable Hgb levels will start the washout period of one to eight weeks. During the washout period, 30 subjects whose Hgb are < 10.0 will complete the baseline assessment to confirm their eligibility. Eligible subjects will be randomly assigned to one of the 3 cohorts in a 1:1:1 ratio. Subjects will be admitted on the day of the first dose and stay in the clinic overnight for pharmacokinetic (PK) sampling after the first (day 1) and the last dose (day 29). FMX-8 will be administered as 30 min i.v. infusion. After the 29-day treatment period, the trial subjects will be observed for an additional 28 days to allow safety and immunogenicity assessments.

Condition or disease Intervention/treatment Phase
Anemia of Chronic Disease Drug: FMX-8 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2A, Uncontrolled, Open-labeled Trial to Evaluate the Effect of FMX-8 Treatment for Anemia in Patients With End Stage Renal Disease (ESRD) on Hemodialysis (HD)
Study Start Date : June 2013
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia

Arm Intervention/treatment
Experimental: FMX-8 (0.5 mg/kg)
0.5 mg/kg FMX-8 IV twice per week for 29 days (9 doses)
Drug: FMX-8
FMX-8 is a fusion protein of the human hemojuvelin (HJV) protein.

Experimental: FMX-8 (5 mg/kg)
5 mg/kg FMX-8 IV twice per week for 29 days (9 doses)
Drug: FMX-8
FMX-8 is a fusion protein of the human hemojuvelin (HJV) protein.

Experimental: FMX-8 (15 mg/kg)
15 mg/kg FMX-8 IV twice per week for 29 days (9 doses)
Drug: FMX-8
FMX-8 is a fusion protein of the human hemojuvelin (HJV) protein.

Primary Outcome Measures :
  1. The proportion of subjects who achieve an increase in Hgb ≥ 1g/dL from the lowest Hgb concentration post erythropoietin-washout or continuing rise in Hgb concentration for two consecutive weeks [ Time Frame: Weekly for 8 weeks ]
  2. Number and Severity of Adverse Events [ Time Frame: 8 weeks ]
  3. Serum FMX-8 levels [ Time Frame: Dosing Days 1 and 29 ]
    Serum drug levels (pre-dose, and 25 minutes, 35 minutes, 1, 2, 4, 6, 10, 16 and 24 hrs post-dose) will be used to determine, for each dose, standard pK profiles

  4. Number of Subjects with Positive Serum for Anti-Drug Antibodies [ Time Frame: At 36 and 57 days after first dose of FMX-8 ]

Secondary Outcome Measures :
  1. Changes in Hgb in each dose group during the treatment and follow-up periods [ Time Frame: Weekly for 8 weeks ]
  2. Proportion of subjects that achieve/maintain an absolute Hgb concentration of ≥ 10.0 g/dL for two consecutive weeks [ Time Frame: Weekly for 8 weeks ]
  3. Time to beginning of steady increase of Hgb (for two consecutive weeks) [ Time Frame: Weekly for 8 weeks ]
  4. Time to Hgb increase ≥1 g/dL [ Time Frame: Weekly for 8 weeks ]
  5. Time to full recovery of Hgb to pre- erythropoietin-washout level [ Time Frame: Weekly for 8 weeks ]
  6. Proportion of subjects needing erythropoietin rescue and length of time to start of rescue therapy [ Time Frame: Weekly for 8 weeks ]
  7. Change of hepcidin and erythropoietin [ Time Frame: At weeks 2, 4, 6 and 8 from baseline ]
  8. Changes in Serum Iron, Tsat and plasma Ferritin [ Time Frame: At weeks 2, 4, 6 and 8 compared to baseline ]

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

Inclusion Criteria:

  • Male or female patients who are ≥18 years old
  • Diagnosed with ESRD and are stable on hemodialysis for more than 3 months
  • Maintained stable Hgb for ≥4 weeks prior to screening
  • Two consecutive Hgb values ≥10.5 g/dL within 5 weeks of screening
  • Body mass index (BMI) between 18 kg/m2 and 42 kg/m2, inclusive, based upon the latest height and weight
  • Ferritin levels ≥100 mg/L or Tsat ≥20% or reticulocyte hemoglobin content (CHr) >25 at screening
  • Reasonable clearances on dialysis (KT/V ≥1.0) on two prior determinations within 2.5 months
  • 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:

  • Hgb remains unchanged without erythropoietin (<0.5 g/dL decrease during the 8 week maximum erythropoietin-washout period)
  • Receipt of iron infusion after the initiation of erythropoietin washout
  • Receipt of red blood cell 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
  • Requirement for Coumadin (warfarin), Pradaxa 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
  • 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
  • Exposure to Omontys® or Hematide® (peginesatide) anemia treatment within the past 6 months
  • Treatment with Aranesp® (darbepoetin alpha) within the past 4 weeks
  • 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 identifier (NCT number): NCT01873534

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United States, Colorado
DaVita Arvada Dialysis Center
Arvada, Colorado, United States, 80005
United States, Minnesota
DaVita Minneapolis Dialysis Unit
Minneapolis, Minnesota, United States, 55404
Sponsors and Collaborators
FerruMax Pharmaceuticals, Inc.
Davita Clinical Research
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Study Chair: Leslie Fang, MD, PhD FerruMax Pharmaceuticals, Inc.
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Responsible Party: FerruMax Pharmaceuticals, Inc. Identifier: NCT01873534    
Other Study ID Numbers: FX-C-402
First Posted: June 10, 2013    Key Record Dates
Last Update Posted: August 11, 2015
Last Verified: July 2015
Keywords provided by FerruMax Pharmaceuticals, Inc.:
Additional relevant MeSH terms:
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Chronic Disease
Hematologic Diseases
Disease Attributes
Pathologic Processes