Chronic Kidney Disease Stage 5 (Dialysis Dependent)Phase 3NCT01222884

A Randomized, Comparative, Open-label Study of IV Monofer® Administered as Maintenance Therapy by Single or Repeated Bolus Injections in Comparison With IV Iron Sucrose in Subjects With CKD-5D

A Phase 3 study testing Monofer and Iron sucrose in people with Chronic Kidney Disease Stage 5 (Dialysis Dependent), run by Pharmacosmos A/S at 1 site in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to compare the efficacy and safety of intravenous iron isomaltoside 1000 with intravenous iron sucrose in patients suffering from 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 Stage 5 (Dialysis Dependent)
What is being tested?: Monofer and Iron sucrose
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 351 participants
Where: 1 siteIndia
Study dates: Jun 2011to Dec 2013
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Subjects with a diagnosis of CKD-5D, in dialysis therapy for at least 90 days prior to inclusion, will be included if they meet all of the following criteria:
Men or women, aged 18 years or greater.
Subjects diagnosed with CKD-5D and in haemodialysis therapy for at least 90 days.
Life expectancy beyond 12 months by Principal Investigator's judgement.
Willingness and ability to participate after Informed Consent.
Hb concentrations between 9.5 g/dL and 12.5 g/dL (both values included) both at Screening Visit 1a and at Screening Visit 1b (screening Visit 1a and Visit 1b must be separated by at least 1 week).

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Serum ferritin < 800 ng/mL.
Transferrin Saturation < 35%.
Subjects receiving ESA treatment with dose stable for the previous 4 weeks prior to screening (with only 1 missed dose to be allowed. Dose to be kept stable during the study period).
Subjects receiving no IV iron or an average of no more than 100 mg/week for the previous 4 weeks (with only 1 missed dose to be allowed).

Who cannot join

Anaemia caused primarily by factors other than renal related anaemia.
Iron overload or disturbances in utilization of iron (e.g. haemochromatosis and haemosiderosis).
Patients currently undergoing treatment with immunosuppresives (low dose steroids are allowed during the study conduct for dosages no more than 10 mg prednisolone/day or equivalent. If possible the dosage should be kept constant through the study).
Difference of Hb ≥ 1.0 g/dL between screening (Visits 1a and 1b).
Patients with a history of multiple allergies.
Decompensated liver cirrhosis or active hepatitis [Alanine Aminotransferase (ALT) > 3 times normal] or history of Hepatitis B or C.

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Active acute or chronic infections (assessed by clinical judgement), supplied with White Blood Cells (WBC) and C - reactive protein (CRP).
Rheumatoid arthritis with symptoms or signs of active joint inflammation.
Pregnancy or nursing. [To avoid pregnancy, women have to be postmenopausal (at least 12 months must have elapsed since last menstruation), surgically sterile, or women of child bearing potential must use one of the following contraceptives during the whole study period and after the study has ended for at least 5 times plasma biological half-life of the investigational medicinal product: Contraceptive pills, Intrauterine Devices (IUD), contraceptive depot injections (prolonged-release gestagen), subdermal implantation, vaginal ring, and transdermal patches]
Blood transfusion within the previous 12 weeks.
Planned elective surgery in the next 8 weeks.
Participation in any other clinical trial within the past 30 days, or if longer, where the study drug has not passed five half-lives 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.

Trial locations and contacts

1 site in 1 country.

India1 site

Jatin Kothari
Mumbai

Other trials in India

About this study

Official title: A Phase III, Randomized, Comparative, Open-label Study of Intravenous Iron Isomaltoside 1000 (Monofer®) Administered as Maintenance Therapy by Single or Repeated Bolus Injections in Comparison With Intravenous Iron Sucrose in Subjects With Stage 5 Chronic Kidney Disease on Dialysis Therapy (CKD-5D)

Conditions: Chronic Kidney Disease Stage 5 (Dialysis Dependent)
Being tested: Monofer, Iron sucrose
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.

MonoferDrug
Iron isomaltoside 1000 (Monofer®) administered as 500 mg intravenous single bolus injection over approximately 2 minutes
Iron sucroseDrug
Iron sucrose is administered undiluted in doses of 100mg at baseline, 200mg at week 2 and 200 mg at week 4 as fractionated IV bolus injections according to local Summary of Product Characteristics

Study groups in NCT01222884
Study group	Role	What they receive
Iron isomaltoside 1000	Active comparator	Iron isomaltoside 1000 (Monofer)administered as 500 mg intravenous single bolus injections OR administered as 500 mg fractionated (100mg+200mg+200mg) intravenous bolus injection Receives: Drug: Monofer
Iron sucrose	Active comparator	Iron sucrose administered as 500 mg fractionated (100mg+200mg+200mg) intravenous bolus injection Receives: Drug: Iron sucrose

What is being measured

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

Ability to Maintain Hemoglobin Level
The primary outcome measure was the proportion of subjects who were able to maintain haemoglobin between 9.5 and 12.5 g/dL (both values included) at week 6. Haemoglobin was measured by a blood sample at the different visits. All blood samples were taken before the dialysis from the dialysis catheter. Intravenous iron was administered during dialysis, at least 30 min after the start and at least 1 h before the end of dialysis.
Measured: Baseline to 6 weeks

Secondary outcomes (1)

Change in Hemoglobin Concentration
Measured: 6 weeks

Timeline

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

Jun 2011Dec 2013

First posted18 Oct 2010 (estimated)
Study startJun 2011
Primary completionOct 2013
Study completionDec 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Chronic Kidney Disease Stage 5 (Dialysis Dependent)Studies 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 351 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01222884
Sponsor's protocol ID: P-Monofer-CKD-03
Status last verified: Jun 2015
First submitted: 15 Oct 2010
Last updated: 2 Dec 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Study at a glance

From the registry record, last updated by the sponsor on 2 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III, Randomized, Comparative, Open-label Study of Intravenous Iron Isomaltoside 1000 (Monofer®) Administered as Maintenance Therapy by Single or Repeated Bolus Injections in Comparison With Intravenous Iron Sucrose in Subjects With Stage 5 Chronic Kidney Disease on Dialysis Therapy (CKD-5D)
ClinicalTrials.gov ID: NCT01222884
Acronym / sponsor ID: P-Monofer-CKD-03
Conditions: Chronic Kidney Disease Stage 5 (Dialysis Dependent)
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 351 participants (actual)
Lead sponsor: Pharmacosmos A/SIndustry (pharma, biotech, devices)
Study start: Jun 2011
Primary completion: Oct 2013 (actual)
Study completion: Dec 2013 (actual)
First posted: 18 Oct 2010 (estimated)
Results: Posted 24 Jul 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Iron isomaltoside 1000	Active comparator	Drug: MonoferIron isomaltoside 1000 (Monofer)administered as 500 mg intravenous single bolus injections OR administered as 500 mg fractionated (100mg+200mg+200mg) intravenous bolus injection
Iron sucrose	Active comparator	Drug: Iron sucroseIron sucrose administered as 500 mg fractionated (100mg+200mg+200mg) intravenous bolus injection

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Subjects with a diagnosis of CKD-5D, in dialysis therapy for at least 90 days prior to inclusion, will be included if they meet all of the following criteria:
Men or women, aged 18 years or greater.
Subjects diagnosed with CKD-5D and in haemodialysis therapy for at least 90 days.
Life expectancy beyond 12 months by Principal Investigator's judgement.
Willingness and ability to participate after Informed Consent.

Key exclusion criteria (14 listed)

Anaemia caused primarily by factors other than renal related anaemia.
Iron overload or disturbances in utilization of iron (e.g. haemochromatosis and haemosiderosis).
Patients currently undergoing treatment with immunosuppresives (low dose steroids are allowed during the study conduct for dosages no more than 10 mg prednisolone/day or equivalent. If possible the dosage should be kept constant through the study).
Difference of Hb ≥ 1.0 g/dL between screening (Visits 1a and 1b).
Patients 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
MonoferIron isomaltoside 1000 (Monofer®) administered as 500 mg intravenous single bolus injection over approximately 2 minutes	Drug	Iron isomaltoside 1000
Iron sucroseIron sucrose is administered undiluted in doses of 100mg at baseline, 200mg at week 2 and 200 mg at week 4 as fractionated IV bolus injections according to local Summary of Product Characteristics	Drug	Iron sucrose

Primary outcome

Ability to Maintain Hemoglobin Level
Time frame: Baseline to 6 weeks
The primary outcome measure was the proportion of subjects who were able to maintain haemoglobin between 9.5 and 12.5 g/dL (both values included) at week 6. Haemoglobin was measured by a blood sample at the different visits. All blood samples were taken before the dialysis from the dialysis catheter. Intravenous iron was administered during dialysis, at least 30 min after the start and at least 1 h before the end of dialysis.

1 secondary outcome

Change in Hemoglobin Concentration
Time frame: 6 weeks

Results and safety

Results posted to the registry on 24 Jul 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Iron Isomaltoside 1000	234	210
Iron Sucrose	117	113

Primary outcome: Ability to Maintain Hemoglobin Level

Time frame: Baseline to 6 weeks. Number. Unit: percentage of participants

Measure	Iron Isomaltoside 1000 n = 226	Iron Sucrose n = 115
Value	82.7	82.6

Population analysed: The FAS population included all subjects who were randomised into the study, received at least one dose of the study drug, and had a Hb assessment. Subjects were included as randomised, regardless of which treatment they actually received.

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Iron Isomaltoside 1000	22 of 230 (9.6%)	42 of 230 (18.3%)	Not reported
Iron Sucrose	6 of 114 (5.3%)	16 of 114 (14%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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.

Lars Lykke Thomsen, MD study chair

Pharmacosmos A/S

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Monofer and Iron sucrose in people with Chronic Kidney Disease Stage 5 (Dialysis Dependent), run by Pharmacosmos A/S at 1 site in India.

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 14 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 2 Dec 2015. 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 India. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Jul 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Ability to Maintain Hemoglobin Level (time frame: Baseline to 6 weeks). 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 NCT01222884.

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 Dec 2015.