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

July 21, 2015 updated by: FerruMax Pharmaceuticals, Inc.

A Phase 2A, Uncontrolled, Open-labeled Trial to Evaluate the Effect of FMX-8 Treatment for Anemia in Patients With End Stage Renal Disease (ESRD) on Hemodialysis (HD)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
6

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

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
    • Colorado
      • Arvada, Colorado, United States, 80005
        • DaVita Arvada Dialysis Center
    • Minnesota
      • Minneapolis, Minnesota, United States, 55404
        • DaVita Minneapolis Dialysis Unit

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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 Criteria:

  • 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

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: FMX-8 (0.5 mg/kg)
0.5 mg/kg FMX-8 IV twice per week for 29 days (9 doses)
Drug: FMX-8
FMX-8 is a fusion protein of the human hemojuvelin (HJV) protein.
Experimental: FMX-8 (5 mg/kg)
5 mg/kg FMX-8 IV twice per week for 29 days (9 doses)
Drug: FMX-8
FMX-8 is a fusion protein of the human hemojuvelin (HJV) protein.
Experimental: FMX-8 (15 mg/kg)
15 mg/kg FMX-8 IV twice per week for 29 days (9 doses)
Drug: FMX-8
FMX-8 is a fusion protein of the human hemojuvelin (HJV) protein.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The proportion of subjects who achieve an increase in Hgb ≥ 1g/dL from the lowest Hgb concentration post erythropoietin-washout or continuing rise in Hgb concentration for two consecutive weeks
Time Frame: Weekly for 8 weeks
Weekly for 8 weeks
Number and Severity of Adverse Events
Time Frame: 8 weeks
8 weeks
Serum FMX-8 levels
Time Frame: Dosing Days 1 and 29
Serum drug levels (pre-dose, and 25 minutes, 35 minutes, 1, 2, 4, 6, 10, 16 and 24 hrs post-dose) will be used to determine, for each dose, standard pK profiles
Dosing Days 1 and 29
Number of Subjects with Positive Serum for Anti-Drug Antibodies
Time Frame: At 36 and 57 days after first dose of FMX-8
At 36 and 57 days after first dose of FMX-8

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Changes in Hgb in each dose group during the treatment and follow-up periods
Time Frame: Weekly for 8 weeks
Weekly for 8 weeks
Proportion of subjects that achieve/maintain an absolute Hgb concentration of ≥ 10.0 g/dL for two consecutive weeks
Time Frame: Weekly for 8 weeks
Weekly for 8 weeks
Time to beginning of steady increase of Hgb (for two consecutive weeks)
Time Frame: Weekly for 8 weeks
Weekly for 8 weeks
Time to Hgb increase ≥1 g/dL
Time Frame: Weekly for 8 weeks
Weekly for 8 weeks
Time to full recovery of Hgb to pre- erythropoietin-washout level
Time Frame: Weekly for 8 weeks
Weekly for 8 weeks
Proportion of subjects needing erythropoietin rescue and length of time to start of rescue therapy
Time Frame: Weekly for 8 weeks
Weekly for 8 weeks
Change of hepcidin and erythropoietin
Time Frame: At weeks 2, 4, 6 and 8 from baseline
At weeks 2, 4, 6 and 8 from baseline
Changes in Serum Iron, Tsat and plasma Ferritin
Time Frame: At weeks 2, 4, 6 and 8 compared to baseline
At weeks 2, 4, 6 and 8 compared to baseline

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
FerruMax Pharmaceuticals, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Davita Clinical Research

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Leslie Fang, MD, PhD, FerruMax Pharmaceuticals, Inc.

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 5, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 7, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 10, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 11, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 21, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FX-C-402

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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