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

Study Overview
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Brief Summary
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FMX-8 is a new type of drug being tested for the treatment of anemia in chronic illnesses.

Official Title
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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

Conditions
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Anemia in Chronic Kidney Disease

Intervention / Treatment
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* Drug: FMX-8


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: FMX-8<br>FMX-8 for injection, 15mg/kg, twice weekly, 29 days | Drug: FMX-8<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in hemoglobin concentration |  | 57 day evaluation period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CKD, Chronic Kidney Disease, Anemia of Chronic Illness