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

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ClinicalTrials.gov Identifier: NCT01873534
Recruitment Status : Terminated (Unable to recruit patients meeting the inclusion criteria)
First Posted : June 10, 2013
Last Update Posted : August 11, 2015
Sponsor:
Collaborator:
Davita Clinical Research
Information provided by (Responsible Party):
FerruMax Pharmaceuticals, Inc.

Tracking Information
First Submitted Date  ICMJE June 5, 2013
First Posted Date  ICMJE June 10, 2013
Last Update Posted Date August 11, 2015
Study Start Date  ICMJE June 2013
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 7, 2013)
  • 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 ]
  • Number and Severity of Adverse Events [ Time Frame: 8 weeks ]
  • 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
  • Number of Subjects with Positive Serum for Anti-Drug Antibodies [ Time Frame: At 36 and 57 days after first dose of FMX-8 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01873534 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 7, 2013)
  • Changes in Hgb in each dose group during the treatment and follow-up periods [ Time Frame: Weekly for 8 weeks ]
  • 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 ]
  • Time to beginning of steady increase of Hgb (for two consecutive weeks) [ Time Frame: Weekly for 8 weeks ]
  • Time to Hgb increase ≥1 g/dL [ Time Frame: Weekly for 8 weeks ]
  • Time to full recovery of Hgb to pre- erythropoietin-washout level [ Time Frame: Weekly for 8 weeks ]
  • Proportion of subjects needing erythropoietin rescue and length of time to start of rescue therapy [ Time Frame: Weekly for 8 weeks ]
  • Change of hepcidin and erythropoietin [ Time Frame: At weeks 2, 4, 6 and 8 from baseline ]
  • Changes in Serum Iron, Tsat and plasma Ferritin [ Time Frame: At weeks 2, 4, 6 and 8 compared to baseline ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase 2A Trial of FMX-8 Treatment for Anemia in Patients With ESRD on Hemodialysis HD
Official Title  ICMJE 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)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Anemia of Chronic Disease
Intervention  ICMJE Drug: FMX-8
FMX-8 is a fusion protein of the human hemojuvelin (HJV) protein.
Study Arms  ICMJE
  • Experimental: FMX-8 (0.5 mg/kg)
    0.5 mg/kg FMX-8 IV twice per week for 29 days (9 doses)
    Intervention: Drug: FMX-8
  • Experimental: FMX-8 (5 mg/kg)
    5 mg/kg FMX-8 IV twice per week for 29 days (9 doses)
    Intervention: Drug: FMX-8
  • Experimental: FMX-8 (15 mg/kg)
    15 mg/kg FMX-8 IV twice per week for 29 days (9 doses)
    Intervention: Drug: FMX-8
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: March 23, 2014)
6
Original Estimated Enrollment  ICMJE
 (submitted: June 7, 2013)
50
Actual Study Completion Date  ICMJE March 2014
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01873534
Other Study ID Numbers  ICMJE FX-C-402
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party FerruMax Pharmaceuticals, Inc.
Study Sponsor  ICMJE FerruMax Pharmaceuticals, Inc.
Collaborators  ICMJE Davita Clinical Research
Investigators  ICMJE
Study Chair: Leslie Fang, MD, PhD FerruMax Pharmaceuticals, Inc.
PRS Account FerruMax Pharmaceuticals, Inc.
Verification Date July 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP