Anemia in Chronic Kidney DiseaseEarly Phase 1NCT02228655
An Exploratory Study to Evaluate FMX-8 to Treat Anemia in CKD
A Early Phase 1 study testing FMX-8 in people with Anemia in Chronic Kidney Disease, run by FerruMax Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
FMX-8 is a new type of drug being tested for the treatment of anemia in chronic illnesses. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia in Chronic Kidney 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
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to Jul 2015
- Phase
- Early Phase 1
- 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
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
Official title: 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.
- Conditions
- Anemia in Chronic Kidney Disease
- Being tested
- FMX-8
- Keywords
- Chronic Kidney Disease, CKD, Anemia of Chronic Illness
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FMX-8Drug
| Study group | Role | What they receive |
|---|---|---|
| FMX-8 | Other | FMX-8 for injection, 15mg/kg, twice weekly, 29 days Receives: Drug: FMX-8 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in hemoglobin concentration
Measured: 57 day evaluation period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2014 (estimated)
- Study startOct 2014
- Primary completionApr 2015
- Study completionJul 2015
Why it stopped: Inability to recruit patients meeting eligibilty criteria.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Anemia in Chronic Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- FerruMax Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stewart Lecker, MD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02228655
- Sponsor's protocol ID
- FX-C-888
- Status last verified
- Feb 2016
- First submitted
- 17 Jul 2014
- Last updated
- 2 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Babitt JL, Huang FW, Wrighting DM, Xia Y, Sidis Y, Samad TA, Campagna JA, Chung RT, Schneyer AL, Woolf CJ, Andrews NC, Lin HY. Bone morphogenetic protein signaling by hemojuvelin regulates hepcidin expression. Nat Genet. 2006 May;38(5):531-9. doi: 10.1038/ng1777. Epub 2006 Apr 9.
PubMed 16604073Babitt JL, Huang FW, Xia Y, Sidis Y, Andrews NC, Lin HY. Modulation of bone morphogenetic protein signaling in vivo regulates systemic iron balance. J Clin Invest. 2007 Jul;117(7):1933-9. doi: 10.1172/JCI31342.
PubMed 17607365Huang FW, Pinkus JL, Pinkus GS, Fleming MD, Andrews NC. A mouse model of juvenile hemochromatosis. J Clin Invest. 2005 Aug;115(8):2187-91. doi: 10.1172/JCI25049.
PubMed 16075059KDOQI. KDOQI Clinical Practice Guideline and Clinical Practice Recommendations for anemia in chronic kidney disease: 2007 update of hemoglobin target. Am J Kidney Dis. 2007 Sep;50(3):471-530. doi: 10.1053/j.ajkd.2007.06.008. No abstract available.
PubMed 17720528Theurl I, Schroll A, Sonnweber T, Nairz M, Theurl M, Willenbacher W, Eller K, Wolf D, Seifert M, Sun CC, Babitt JL, Hong CC, Menhall T, Gearing P, Lin HY, Weiss G. Pharmacologic inhibition of hepcidin expression reverses anemia of chronic inflammation in rats. Blood. 2011 Nov 3;118(18):4977-84. doi: 10.1182/blood-2011-03-345066. Epub 2011 Jul 5.
PubMed 21730356Weiss G, Goodnough LT. Anemia of chronic disease. N Engl J Med. 2005 Mar 10;352(10):1011-23. doi: 10.1056/NEJMra041809. No abstract available.
PubMed 15758012Weiner DE. Causes and consequences of chronic kidney disease: implications for managed health care. J Manag Care Pharm. 2007 Apr;13(3 Suppl):S1-9. doi: 10.18553/jmcp.2007.13.s3.1.
PubMed 17402808
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02228655
- Acronym / sponsor ID
- FX-C-888
- Conditions
- Anemia in Chronic Kidney Disease
- Keywords
- Chronic Kidney Disease, CKD, Anemia of Chronic Illness
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inability to recruit patients meeting eligibilty criteria.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- FerruMax Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 29 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
FMX-8 is a new type of drug being tested for the treatment of anemia in chronic illnesses.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FMX-8 | Other | Drug: FMX-8FMX-8 for injection, 15mg/kg, twice weekly, 29 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FMX-8 | Drug | FMX-8 |
Primary outcome
Change in hemoglobin concentration
Time frame: 57 day evaluation period
Results and safety
The study was stopped early (reason given: Inability to recruit patients meeting eligibilty criteria.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2016.
- Background: PubMed 16604073Babitt JL, Huang FW, Wrighting DM, Xia Y, Sidis Y, Samad TA, Campagna JA, Chung RT, Schneyer AL, Woolf CJ, Andrews NC, Lin HY. Bone morphogenetic protein signaling by hemojuvelin regulates hepcidin expression. Nat Genet. 2006 May;38(5):531-9. doi: 10.1038/ng1777. Epub 2006 Apr 9.
- Background: PubMed 17607365Babitt JL, Huang FW, Xia Y, Sidis Y, Andrews NC, Lin HY. Modulation of bone morphogenetic protein signaling in vivo regulates systemic iron balance. J Clin Invest. 2007 Jul;117(7):1933-9. doi: 10.1172/JCI31342.
- Background: PubMed 16075059Huang FW, Pinkus JL, Pinkus GS, Fleming MD, Andrews NC. A mouse model of juvenile hemochromatosis. J Clin Invest. 2005 Aug;115(8):2187-91. doi: 10.1172/JCI25049.
- Background: PubMed 17720528KDOQI. KDOQI Clinical Practice Guideline and Clinical Practice Recommendations for anemia in chronic kidney disease: 2007 update of hemoglobin target. Am J Kidney Dis. 2007 Sep;50(3):471-530. doi: 10.1053/j.ajkd.2007.06.008. No abstract available.
- Background: PubMed 21730356Theurl I, Schroll A, Sonnweber T, Nairz M, Theurl M, Willenbacher W, Eller K, Wolf D, Seifert M, Sun CC, Babitt JL, Hong CC, Menhall T, Gearing P, Lin HY, Weiss G. Pharmacologic inhibition of hepcidin expression reverses anemia of chronic inflammation in rats. Blood. 2011 Nov 3;118(18):4977-84. doi: 10.1182/blood-2011-03-345066. Epub 2011 Jul 5.
- Background: PubMed 15758012Weiss G, Goodnough LT. Anemia of chronic disease. N Engl J Med. 2005 Mar 10;352(10):1011-23. doi: 10.1056/NEJMra041809. No abstract available.
- Background: PubMed 17402808Weiner DE. Causes and consequences of chronic kidney disease: implications for managed health care. J Manag Care Pharm. 2007 Apr;13(3 Suppl):S1-9. doi: 10.18553/jmcp.2007.13.s3.1.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stewart Lecker, MD principal investigator
Beth Israel Deaconess Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing FMX-8 in people with Anemia in Chronic Kidney Disease, run by FerruMax Pharmaceuticals, Inc. at 1 site 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 8 inclusion and 19 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 2 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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: Inability to recruit patients meeting eligibilty 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?
Change in hemoglobin concentration (time frame: 57 day evaluation period). 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 NCT02228655, which also lists 7 linked publications.
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 2 Feb 2016.