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Anemia of Chronic DiseasePhase 2NCT01873534

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

A Phase 2 study testing FMX-8 in people with Anemia of Chronic Disease, run by FerruMax Pharmaceuticals, Inc. at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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 observation period. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Anemia of Chronic Disease
What is being tested?
FMX-8
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
2 sitesUnited States
Study dates
Jun 2013to Mar 2014
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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

Who cannot join

  • 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
Show all 22Show fewer
  • 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • DaVita Arvada Dialysis Center

    Arvada, Colorado, 80005

  • DaVita Minneapolis Dialysis Unit

    Minneapolis, Minnesota, 55404

Other trials in United States

About this study

Official title: 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.

Being tested
FMX-8
Keywords
Anemia
Medical subject headings
Anemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FMX-8Drug

    FMX-8 is a fusion protein of the human hemojuvelin (HJV) protein.

Study groups in NCT01873534
Study groupRoleWhat they receive
FMX-8 (0.5 mg/kg)Experimental0.5 mg/kg FMX-8 IV twice per week for 29 days (9 doses)
Receives: Drug: FMX-8
FMX-8 (5 mg/kg)Experimental5 mg/kg FMX-8 IV twice per week for 29 days (9 doses)
Receives: Drug: FMX-8
FMX-8 (15 mg/kg)Experimental15 mg/kg FMX-8 IV twice per week for 29 days (9 doses)
Receives: Drug: FMX-8

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Weekly for 8 weeks

  2. Number and Severity of Adverse Events

    Measured: 8 weeks

  3. Serum FMX-8 levels

    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

    Measured: Dosing Days 1 and 29

  4. Number of Subjects with Positive Serum for Anti-Drug Antibodies

    Measured: At 36 and 57 days after first dose of FMX-8

Secondary outcomes (8)

  1. Changes in Hgb in each dose group during the treatment and follow-up periods

    Measured: Weekly for 8 weeks

  2. Proportion of subjects that achieve/maintain an absolute Hgb concentration of ≥ 10.0 g/dL for two consecutive weeks

    Measured: Weekly for 8 weeks

  3. Time to beginning of steady increase of Hgb (for two consecutive weeks)

    Measured: Weekly for 8 weeks

  4. Time to Hgb increase ≥1 g/dL

    Measured: Weekly for 8 weeks

  5. Time to full recovery of Hgb to pre- erythropoietin-washout level

    Measured: Weekly for 8 weeks

  6. Proportion of subjects needing erythropoietin rescue and length of time to start of rescue therapy

    Measured: Weekly for 8 weeks

  7. Change of hepcidin and erythropoietin

    Measured: At weeks 2, 4, 6 and 8 from baseline

  8. Changes in Serum Iron, Tsat and plasma Ferritin

    Measured: At weeks 2, 4, 6 and 8 compared to baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jun 2013 (estimated)
  2. Study startJun 2013
  3. Primary completionMar 2014
  4. Study completionMar 2014

Why it stopped: Unable to recruit patients meeting the inclusion criteria

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01873534
Sponsor's protocol ID
FX-C-402
Status last verified
Jul 2015
First submitted
5 Jun 2013
Last updated
11 Aug 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing FMX-8 in people with Anemia of Chronic Disease, run by FerruMax Pharmaceuticals, Inc. at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 11 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Unable to recruit patients meeting the inclusion criteria). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01873534.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2015.

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