Iron Deficiency AnemiaPhase 3NCT01102413

Iron Isomaltoside 1000 (Monofer®) in Non-Dialysis Dependent Chronic Kidney Disease and With Renal-Related Anaemia

A Phase 3 study testing Monofer and Iron Sulphate in people with Iron Deficiency Anemia and Chronic Kidney Disease, run by Pharmacosmos A/S at 1 site in Denmark.

Completed

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

Official record

Search all trials

Trial summary

The study is designed to determine the effects of an investigational drug Monofer in subjects with non-dialysis dependent chronic kidney disease (NDD-CKD) subjects and with iron deficiency anaemia (IDA). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Iron Deficiency Anemia, Chronic Kidney Disease
What is being tested?: Monofer and Iron Sulphate
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 351 participants
Where: 1 siteDenmark
Study dates: Apr 2010to Jun 2014
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

Men and women, aged more than 18 years.
Subjects diagnosed with NDD-CKD with MDRD calculated eGFR between 15-59 mL/min.
Hb < 11.0 g/dL (6.80 mmol/L)
Either or both of the following iron stores indicators below target {Serum ferritin < 100 ug/l and Transferrin saturation (TfS)<20%}.
Life expectancy beyond 12 months by Principal Investigator's judgement.
Willingness to participate after informed consent and any authorization as required by local law ( e.g. Protected Health Information [PHI] for North America).

Who cannot join

Anaemia predominantly caused by factors other than renal impairment or iron deficiency (according to Principal Investigator's judgment).
Iron overload or disturbances in utilisation of iron (e.g. haemochromatosis and haemosiderosis).
Drug hypersensitivity (i.e. previous hypersensitivity to Iron Dextran or iron mono- or disaccharide complexes or to iron sulphate or any excipients of the study drug.
Subjects with history of multiple allergies.
Decompensated liver cirrhosis or active hepatitis (Alanine Aminotransferase (ALT) > 3 times upper normal limit).
Active acute or chronic infections ((assessed by clinical judgment), supplied with White Blood Cells (WBC) and C-Reactive Protein (CRP)).

Show all 18Show fewer

Rheumatoid arthritis with symptoms or signs of active joint inflammation.
Pregnancy and 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 (5 days): Contraceptive pills, intrauterine devices (IUD), contraceptive depot injections (prolonged-release gestagen), subdermal implantation, vaginal ring, and transdermal patches).
Extensive active bleeding necessitating blood transfusion.
Planned elective surgery during the study.
Participation in any other clinical study within 3 months prior to screening.
Known intolerance to oral iron treatment.
Untreated B12 or folate deficiency.
I.V. or oral iron treatment or blood transfusion within 4 weeks prior to screening visit.
ESA treatment within 8 weeks prior to screening visit.
Serum ferritin > 500 µg/L.
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 or interfere with study drug evaluation. Example, Uncontrolled Hypertension, Unstable Ischemic Heart Disease or Uncontrolled Diabetes Mellitus.
Body weight < 30 kilograms.

Trial locations and contacts

1 site in 1 country.

Denmark1 site

Pharmacosmos
Holbæk

Other trials in Denmark

About this study

Official title: A Phase III, Randomized, Comparative, Open-label Study of Intravenous Iron Isomaltoside 1000 (Monofer®) Administered by Infusions or Repeated Bolus Injections in Comparison With Oral Iron Sulphate in Subjects With Non-Dialysis Dependent Chronic Kidney Disease and With Renal-Related Anaemia

Conditions: Iron Deficiency Anemia, Chronic Kidney Disease
Being tested: Monofer, Iron Sulphate
Medical subject headings: Anemia, Iron-Deficiency, Renal Insufficiency, Chronic

What participants receive

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

MonoferDrug
Infusion or injections
Iron SulphateDrug
Oral intake

Study groups in NCT01102413
Study group	Role	What they receive
Monofer	Experimental	Injections or infusions Receives: Drug: Monofer
Iron Sulphate	Active comparator	Oral intake Receives: Drug: Iron Sulphate

What is being measured

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

Change in Hemoglobin (Hb) Concentration From Baseline to Week 4.
Measured: Baseline, 4 weeks

Secondary outcomes (1)

Change in Hemoglobin Concentration From Baseline to Week 8
Measured: Baseline to week 8

Timeline

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

Apr 2010Jun 2014

First posted13 Apr 2010 (estimated)
Study startApr 2010
Primary completionJun 2014
Study completionJun 2014

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 Iron Deficiency AnemiaStudies 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: NCT01102413
Sponsor's protocol ID: P-Monofer-CKD-02
Status last verified: Nov 2015
First submitted: 26 Mar 2010
Last updated: 3 Dec 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life
Heart Failure With Preserved Ejection Fraction, Iron Deficiencies
Recruiting
The Effects of Iron Treatment on Vaccine Immunogenicity in Kenyan Infants With Iron Deficiency
Iron Deficiencies
RecruitingPhase 4
The Effects of Low-Dose Versus High-Dose Intravenous IRON Therapy With Ferric DerisomaltOSE in Patients With Chronic Heart Failure and Iron Deficiency
Heart Failure, Iron Deficiency
Enrolling by invitationObservational study
Long-term Impacts of Psychosocial Stimulation and Iron Supplementation
Iron Deficiency Anemia, Parenting Intervention

All Iron Deficiency Anemia trials

Study at a glance

From the registry record, last updated by the sponsor on 3 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 by Infusions or Repeated Bolus Injections in Comparison With Oral Iron Sulphate in Subjects With Non-Dialysis Dependent Chronic Kidney Disease and With Renal-Related Anaemia
ClinicalTrials.gov ID: NCT01102413
Acronym / sponsor ID: P-Monofer-CKD-02
Conditions: Iron Deficiency Anemia, Chronic Kidney Disease
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 351 participants (actual)
Lead sponsor: Pharmacosmos A/SIndustry (pharma, biotech, devices)
Study start: Apr 2010
Primary completion: Jun 2014 (actual)
Study completion: Jun 2014 (actual)
First posted: 13 Apr 2010 (estimated)
Results: Posted 3 Dec 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
Monofer	Experimental	Drug: MonoferInjections or infusions
Iron Sulphate	Active comparator	Drug: Iron SulphateOral intake

Who may qualify

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

Key inclusion criteria (6 listed)

Men and women, aged more than 18 years.
Subjects diagnosed with NDD-CKD with MDRD calculated eGFR between 15-59 mL/min.
Hb < 11.0 g/dL (6.80 mmol/L)
Either or both of the following iron stores indicators below target {Serum ferritin < 100 ug/l and Transferrin saturation (TfS)<20%}.
Life expectancy beyond 12 months by Principal Investigator's judgement.

Key exclusion criteria (18 listed)

Anaemia predominantly caused by factors other than renal impairment or iron deficiency (according to Principal Investigator's judgment).
Iron overload or disturbances in utilisation of iron (e.g. haemochromatosis and haemosiderosis).
Drug hypersensitivity (i.e. previous hypersensitivity to Iron Dextran or iron mono- or disaccharide complexes or to iron sulphate or any excipients of the study drug.
Subjects with history of multiple allergies.
Decompensated liver cirrhosis or active hepatitis (Alanine Aminotransferase (ALT) > 3 times upper normal limit).

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
MonoferInfusion or injections	Drug	Monofer
Iron SulphateOral intake	Drug	Iron Sulphate

Primary outcome

Change in Hemoglobin (Hb) Concentration From Baseline to Week 4.
Time frame: Baseline, 4 weeks

1 secondary outcome

Change in Hemoglobin Concentration From Baseline to Week 8
Time frame: Baseline to week 8

Results and safety

Results posted to the registry on 3 Dec 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
Monofer	233	208
Iron Sulphate	118	106

Primary outcome: Change in Hemoglobin (Hb) Concentration From Baseline to Week 4.

Time frame: Baseline, 4 weeks. Mean (Full Range). Unit: g/dL

Measure	Monofer n = 209	Iron Sulphate n = 108
Value	0.57 (-3.1 to 4.0)	0.35 (-3.7 to 3.9)

Population analysed: The FAS population included all the subjects who were randomised into the study, received at least one dose of the study drug, and had at least one post-baseline Hb assessment. The subjects were considered 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
Monofer	12 of 228 (5.3%)	48 of 228 (21.1%)	Not reported
Iron Sulphate	10 of 117 (8.5%)	22 of 117 (18.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Iron Deficiency Anemia

RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life
Heart Failure With Preserved Ejection Fraction, Iron Deficiencies
Recruiting
The Effects of Iron Treatment on Vaccine Immunogenicity in Kenyan Infants With Iron Deficiency
Iron Deficiencies
RecruitingPhase 4
The Effects of Low-Dose Versus High-Dose Intravenous IRON Therapy With Ferric DerisomaltOSE in Patients With Chronic Heart Failure and Iron Deficiency
Heart Failure, Iron Deficiency
Enrolling by invitationObservational study
Long-term Impacts of Psychosocial Stimulation and Iron Supplementation
Iron Deficiency Anemia, Parenting Intervention

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.

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 Sulphate in people with Iron Deficiency Anemia and Chronic Kidney Disease, run by Pharmacosmos A/S at 1 site in Denmark.

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 6 inclusion and 18 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 3 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 Denmark. 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 3 Dec 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?

Change in Hemoglobin (Hb) Concentration From Baseline to Week 4. (time frame: Baseline, 4 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 NCT01102413.

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 3 Dec 2015.