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

February 1, 2016 updated by: FerruMax Pharmaceuticals, Inc.

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in hemoglobin concentration
Time Frame: 57 day evaluation period
57 day evaluation period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

FerruMax Pharmaceuticals, Inc.

Investigators

  • Principal Investigator: Stewart Lecker, MD, Beth Israel Deaconess Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

July 17, 2014

First Submitted That Met QC Criteria

August 27, 2014

First Posted (Estimate)

August 29, 2014

Study Record Updates

Last Update Posted (Estimate)

February 2, 2016

Last Update Submitted That Met QC Criteria

February 1, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FX-C-888

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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