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

Primary Purpose

Anemia of Chronic Disease

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
FMX-8
Sponsored by
FerruMax Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anemia of Chronic Disease focused on measuring Anemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • DaVita Arvada Dialysis Center
  • DaVita Minneapolis Dialysis Unit

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

FMX-8 (0.5 mg/kg)

FMX-8 (5 mg/kg)

FMX-8 (15 mg/kg)

Arm Description

0.5 mg/kg FMX-8 IV twice per week for 29 days (9 doses)

5 mg/kg FMX-8 IV twice per week for 29 days (9 doses)

15 mg/kg FMX-8 IV twice per week for 29 days (9 doses)

Outcomes

Primary Outcome Measures

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
Number and Severity of Adverse Events
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
Number of Subjects with Positive Serum for Anti-Drug Antibodies

Secondary Outcome Measures

Changes in Hgb in each dose group during the treatment and follow-up periods
Proportion of subjects that achieve/maintain an absolute Hgb concentration of ≥ 10.0 g/dL for two consecutive weeks
Time to beginning of steady increase of Hgb (for two consecutive weeks)
Time to Hgb increase ≥1 g/dL
Time to full recovery of Hgb to pre- erythropoietin-washout level
Proportion of subjects needing erythropoietin rescue and length of time to start of rescue therapy
Change of hepcidin and erythropoietin
Changes in Serum Iron, Tsat and plasma Ferritin

Full Information

First Posted
June 5, 2013
Last Updated
July 21, 2015
Sponsor
FerruMax Pharmaceuticals, Inc.
Collaborators
Davita Clinical Research
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1. Study Identification

Unique Protocol Identification Number
NCT01873534
Brief Title
A Phase 2A Trial of FMX-8 Treatment for Anemia in Patients With ESRD on Hemodialysis HD
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)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Terminated
Why Stopped
Unable to recruit patients meeting the inclusion criteria
Study Start Date
June 2013 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
FerruMax Pharmaceuticals, Inc.
Collaborators
Davita Clinical Research

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia of Chronic Disease
Keywords
Anemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FMX-8 (0.5 mg/kg)
Arm Type
Experimental
Arm Description
0.5 mg/kg FMX-8 IV twice per week for 29 days (9 doses)
Arm Title
FMX-8 (5 mg/kg)
Arm Type
Experimental
Arm Description
5 mg/kg FMX-8 IV twice per week for 29 days (9 doses)
Arm Title
FMX-8 (15 mg/kg)
Arm Type
Experimental
Arm Description
15 mg/kg FMX-8 IV twice per week for 29 days (9 doses)
Intervention Type
Drug
Intervention Name(s)
FMX-8
Intervention Description
FMX-8 is a fusion protein of the human hemojuvelin (HJV) protein.
Primary Outcome Measure Information:
Title
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
Title
Number and Severity of Adverse Events
Time Frame
8 weeks
Title
Serum FMX-8 levels
Description
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
Time Frame
Dosing Days 1 and 29
Title
Number of Subjects with Positive Serum for Anti-Drug Antibodies
Time Frame
At 36 and 57 days after first dose of FMX-8
Secondary Outcome Measure Information:
Title
Changes in Hgb in each dose group during the treatment and follow-up periods
Time Frame
Weekly for 8 weeks
Title
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
Title
Time to beginning of steady increase of Hgb (for two consecutive weeks)
Time Frame
Weekly for 8 weeks
Title
Time to Hgb increase ≥1 g/dL
Time Frame
Weekly for 8 weeks
Title
Time to full recovery of Hgb to pre- erythropoietin-washout level
Time Frame
Weekly for 8 weeks
Title
Proportion of subjects needing erythropoietin rescue and length of time to start of rescue therapy
Time Frame
Weekly for 8 weeks
Title
Change of hepcidin and erythropoietin
Time Frame
At weeks 2, 4, 6 and 8 from baseline
Title
Changes in Serum Iron, Tsat and plasma Ferritin
Time Frame
At weeks 2, 4, 6 and 8 compared to baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leslie Fang, MD, PhD
Organizational Affiliation
FerruMax Pharmaceuticals, Inc.
Official's Role
Study Chair
Facility Information:
Facility Name
DaVita Arvada Dialysis Center
City
Arvada
State/Province
Colorado
ZIP/Postal Code
80005
Country
United States
Facility Name
DaVita Minneapolis Dialysis Unit
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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