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

Stopped early · Phase 2

Conditions studied: Anemia of Chronic Disease

In brief

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.

Key facts

Study ID: NCT01873534
Run by: FerruMax Pharmaceuticals, Inc.
People needed: 6
Starts: 2013-06-01
Expected to finish: 2014-03-01
Last updated by the study team: 2015-08-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

DaVita Arvada Dialysis Center — Arvada, Colorado, United States
DaVita Minneapolis Dialysis Unit — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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