Status:
TERMINATED
A Phase 2A Trial of FMX-8 Treatment for Anemia in Patients With ESRD on Hemodialysis HD
Lead Sponsor:
FerruMax Pharmaceuticals, Inc.
Collaborating Sponsors:
Davita Clinical Research
Conditions:
Anemia of Chronic Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT01873534
Start Date
June 1 2013
End Date
March 1 2014
Last Update
August 11 2015
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
DaVita Arvada Dialysis Center
Arvada, Colorado, United States, 80005
2
DaVita Minneapolis Dialysis Unit
Minneapolis, Minnesota, United States, 55404