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

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

Sponsors

Lead Sponsor: FerruMax Pharmaceuticals, Inc.

Source FerruMax Pharmaceuticals, Inc.
Brief Summary

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

Overall Status Terminated
Start Date October 2014
Completion Date July 2015
Primary Completion Date April 2015
Phase Early Phase 1
Study Type Interventional
Primary Outcome
Measure Time Frame
Change in hemoglobin concentration 57 day evaluation period
Enrollment 2
Condition
Intervention

Intervention Type: Drug

Intervention Name: FMX-8

Arm Group Label: FMX-8

Eligibility

Criteria:

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Stewart Lecker, MD Principal Investigator Beth Israel Deaconess Medical Center
Location
Facility: Beth Israel Deaconess Medical Center
Location Countries

United States

Verification Date

February 2016

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: FMX-8

Type: Other

Description: FMX-8 for injection, 15mg/kg, twice weekly, 29 days

Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov