Chronic Kidney DiseasePhase 1NCT01469078
Open-label Pharmacokinetic Study of Iron Isomaltoside 1000 (Monofer®) Administered as Single Bolus Injections in Subjects With Stage 5 Chronic Kidney Disease on Dialysis Therapy (CKD-5D)
A Phase 1 study testing Monofer® in people with Chronic Kidney Disease, run by Pharmacosmos A/S.
Trial summary
The purpose of this study is to assess Pharmakokinetic properties of iron isomaltoside 1000 (Monofer®) in doses of 100 mg, 200 mg or 500 mg in subjects with Stage 5 Chronic Kidney Disease on Dialysis Therapy (CKD-5D). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- Monofer®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- Oct 2011to Nov 2012
- Phase
- 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
- Men and women, aged more than 18 years.
- Weight above 50 kg.
- Subjects diagnosed with CKD-5D and on dialysis therapy for at least 90 days prior to inclusion.
- Serum ferritin ≤ 800 ng/mL.
- Transferrin Saturation ≤ 35%.
- Life expectancy beyond 12 months by Principal Investigator's judgement.
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- Hb concentrations ≥10.0 g/dL and ≤12.5 g/dL both at Screening Visit 1a and at Screening Visit 1b (Screening Visit 1a and Visit 1b must be separated by at least 1 week).
- Erythropoiesis Stimulating Agent (ESA) treatment (to be kept constant during the study period and for 4 weeks prior to inclusion with only one missed dose to be allowed during this pre-entry period).
- Subjects in maintenance iron therapy with average iron administration ≤ 100 mg/week for 4 weeks prior to inclusion and willingness to switch to investigational product.
- Willingness and ability to participate after informed consent (including HIPAA, if applicable).
Who cannot join
- Anemia caused primarily by other factors than renal related anemia.
- Iron overload or disturbances in utilization of iron (e.g. hemochromatosis and hemosiderosis).
- Difference of Hb ≥ 1.0 g/dL between Screening Visits 1a and 1b.
- Known hypersensitivity to any excipients in the investigational drug products.
- Subjects with a history of multiple allergies.
- Decompensated liver cirrhosis and history of hepatitis B or C [Alanine Aminotransferase (ALT) > 3 times upper limit of normal].
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- Acute or chronic infections (assessed by clinical investigator judgment), supported by White Blood Cells (WBC) and C-Reactive Protein (CRP).
- Rheumatoid arthritis with symptoms or signs of active joint inflammation.
- Pregnant or nursing women.
- Women of child bearing potential who are not using safe contraceptive methods (e.g. intrauterine device, oral contraceptives or surgically sterilized) or who are planning to become pregnant within the study period.
- Blood transfusion within the previous 12 weeks.
- Planned elective surgery during the study where significant blood loss is expected.
- Participation in any other clinical trial within 3 months prior to screening.
- Untreated Vitamin B12 or folate deficiency.
- Any other medical condition that, in the opinion of Principal Investigator, may cause the subject to be unsuitable for the completion of the study or place the subject at potential risk from being in the study. Examples include Uncontrolled Hypertension, Unstable Ischemic Heart Disease or Uncontrolled Diabetes Mellitus.
About this study
Official title: Open-label Pharmacokinetic Study of Iron Isomaltoside 1000 (Monofer®) Administered as Single Bolus Injections in Subjects With Stage 5 Chronic Kidney Disease on Dialysis Therapy (CKD-5D) (PK-CKD-05)
The purpose of this study is to assess Pharmakokinetic properties of iron isomaltoside 1000 (Monofer®) in doses of 100 mg, 200 mg or 500 mg in subjects with Stage 5 Chronic Kidney Disease on Dialysis Therapy (CKD-5D).
- Conditions
- Chronic Kidney Disease
- Being tested
- Monofer®
- Keywords
- Chronic Kidney Disease, CKD stage 5, Iron deficiency
- Medical subject headings
- Renal Insufficiency, Chronic, Iron Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monofer®Drug
Single Bolus Injections
| Study group | Role | What they receive |
|---|---|---|
| 100 mg Monofer® | Active comparator | Not described Receives: Drug: Monofer® |
| 200 mg Monofer® | Active comparator | Not described Receives: Drug: Monofer® |
| 500 mg Monofer® | Active comparator | Not described Receives: Drug: Monofer® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of changes in Iron pharmacokinetic parameters from plasma/serum concentration profile
The follwoing parameter will be determined: AUC0-t, AUC, Cmax, Tmax, Ke, and T1/2
Measured: From exposure to 7 days post-exposure
Secondary outcomes (2)
Changes in pharmacodynamic parametres
Changes in the following parametres will be determined: Hemoglobin (Hb), Reticulocyte Count, Reticuloycyte Hemoglobin Content (CHr), Ferritin, Total Iron Binding Capacity (TIBC) and Transferrin Saturation (TfS)
Measured: From 0 hours to 4, 8, 24, 48, 72 hours post-exposure and end of study visit
Safety evaluation
The following parameters will be evaluated: Laboratory safety variable, physical examination, vital signs and Electrocardiogram (ECG)
Measured: From screening to 7 days post-exposure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2011 (estimated)
- Study startOct 2011
- Primary completionApr 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Phase 1
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pharmacosmos A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ClinSmart
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01469078
- Sponsor's protocol ID
- P-Monofer-PK-CKD-05
- Status last verified
- Nov 2012
- First submitted
- 27 Oct 2011
- Last updated
- 8 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label Pharmacokinetic Study of Iron Isomaltoside 1000 (Monofer®) Administered as Single Bolus Injections in Subjects With Stage 5 Chronic Kidney Disease on Dialysis Therapy (CKD-5D) (PK-CKD-05)
- ClinicalTrials.gov ID
- NCT01469078
- Acronym / sponsor ID
- P-Monofer-PK-CKD-05
- Conditions
- Chronic Kidney Disease
- Keywords
- Chronic Kidney Disease, CKD stage 5, Iron deficiency
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Pharmacosmos A/SIndustry (pharma, biotech, devices)
- Collaborators
- ClinSmart
- Study start
- Oct 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 10 Nov 2011 (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.
The purpose of this study is to assess Pharmakokinetic properties of iron isomaltoside 1000 (Monofer®) in doses of 100 mg, 200 mg or 500 mg in subjects with Stage 5 Chronic Kidney Disease on Dialysis Therapy (CKD-5D).
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 100 mg Monofer® | Active comparator | Drug: Monofer® |
| 200 mg Monofer® | Active comparator | Drug: Monofer® |
| 500 mg Monofer® | Active comparator | Drug: Monofer® |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Men and women, aged more than 18 years.
- Weight above 50 kg.
- Subjects diagnosed with CKD-5D and on dialysis therapy for at least 90 days prior to inclusion.
- Serum ferritin ≤ 800 ng/mL.
- Transferrin Saturation ≤ 35%.
Key exclusion criteria (15 listed)
- Anemia caused primarily by other factors than renal related anemia.
- Iron overload or disturbances in utilization of iron (e.g. hemochromatosis and hemosiderosis).
- Difference of Hb ≥ 1.0 g/dL between Screening Visits 1a and 1b.
- Known hypersensitivity to any excipients in the investigational drug products.
- Subjects with a history of multiple allergies.
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 |
|---|---|---|
| Monofer®Single Bolus Injections | Drug | 100 mg Monofer®, 200 mg Monofer®, 500 mg Monofer® |
Primary outcome
Determination of changes in Iron pharmacokinetic parameters from plasma/serum concentration profile
Time frame: From exposure to 7 days post-exposure
The follwoing parameter will be determined: AUC0-t, AUC, Cmax, Tmax, Ke, and T1/2
2 secondary outcomes
Changes in pharmacodynamic parametres
Time frame: From 0 hours to 4, 8, 24, 48, 72 hours post-exposure and end of study visit
Safety evaluation
Time frame: From screening to 7 days post-exposure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Monofer® in people with Chronic Kidney Disease, run by Pharmacosmos A/S.
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 15 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: finished, as of the sponsor's last update on 8 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Determination of changes in Iron pharmacokinetic parameters from plasma/serum concentration profile (time frame: From exposure to 7 days post-exposure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Nov 2012.