AnemiaNCT01309269

Observational Study to Investigate the Long-term Effects of MIRCERA in Clinical Routine

An observational study of Anemia, run by Hoffmann-La Roche at 1 site in Germany.

Completed

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

Trial summary

This observational study will assess the effect of long-term treatment with Mircera (methoxy polyethylene glycol-epoetin beta) in chronic kidney disease patients with renal anemia. Data will be collected from each patient for at least 24 months. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Anemia
How many people: 1,083 participants
Where: 1 siteGermany
Study dates: Sep 2010to Apr 2014
Phase: Observational
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

Study population: Chronic kidney disease patients treated with Mircera for renal anemia

Who may be able to join

Adult patients, >/= 18 years of age
Patients with chronic kidney disease (CKD), stages IV and V
Treatment with Mircera according to label

Who cannot join

Pregnant or breastfeeding women

Trial locations and contacts

1 site in 1 country.

Germany1 site

Study site
Lüdenscheid, 58515

Other trials in Germany

About this study

Official title: Non-interventional Study to Investigate the Long Term Effects of MIRCERA in Clinical Routine

Conditions: Anemia
Medical subject headings: Anemia

What participants receive

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

Study groups in NCT01309269
Study group	Role	What they receive
Cohort		Not described

What is being measured

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

Hemoglobin Levels at Monthly Intervals
Hemoglobin levels were measured as grams/deciliter (g/dL).
Measured: Prior to Day 1, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24
Percentage of Participants Within Pre-defined Range of Hemoglobin Values
Percentage of participants with hemoglobin values within the following pre-defined ranges is presented: 11-12 gram/deciliter (g/dL), 10-12 g/dL, 11-13 g/dL, and 10-13 g/dL.
Measured: Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24
Average Methoxy Polyethylene Glycol-epoetin Beta Dose
Average methoxy polyethylene glycol-epoetin beta dose per application by study month. Mean values were taken when more than 1 application was documented for a participant during the time period considered.
Measured: Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24

Timeline

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

Sep 2010Apr 2014

First posted7 Mar 2011 (estimated)
Study startSep 2010
Primary completionApr 2014
Study completionApr 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 AnemiaStudies of the same condition, open and under way.
More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 1,083 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01309269
Sponsor's protocol ID: ML22911
Status last verified: Nov 2016
First submitted: 3 Mar 2011
Last updated: 2 Nov 2016
Results posted: Yes, on ClinicalTrials.gov

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

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All Anemia trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Non-interventional Study to Investigate the Long Term Effects of MIRCERA in Clinical Routine
ClinicalTrials.gov ID: NCT01309269
Acronym / sponsor ID: ML22911
Conditions: Anemia
Study type: Observational
Recruitment status: Completed
Enrolment: 1,083 participants (actual)
Lead sponsor: Hoffmann-La RocheIndustry (pharma, biotech, devices)
Study start: Sep 2010
Primary completion: Apr 2014 (actual)
Study completion: Apr 2014 (actual)
First posted: 7 Mar 2011 (estimated)
Results: Posted 29 Oct 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

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Cohort	–	–

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Chronic kidney disease patients treated with Mircera for renal anemia

Key inclusion criteria (3 listed)

Adult patients, >/= 18 years of age
Patients with chronic kidney disease (CKD), stages IV and V
Treatment with Mircera according to label

Key exclusion criteria (1 listed)

Pregnant or breastfeeding women

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Hemoglobin Levels at Monthly Intervals
Time frame: Prior to Day 1, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24
Hemoglobin levels were measured as grams/deciliter (g/dL).
Percentage of Participants Within Pre-defined Range of Hemoglobin Values
Time frame: Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24
Percentage of participants with hemoglobin values within the following pre-defined ranges is presented: 11-12 gram/deciliter (g/dL), 10-12 g/dL, 11-13 g/dL, and 10-13 g/dL.
Average Methoxy Polyethylene Glycol-epoetin Beta Dose
Time frame: Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24
Average methoxy polyethylene glycol-epoetin beta dose per application by study month. Mean values were taken when more than 1 application was documented for a participant during the time period considered.

Results and safety

Results posted to the registry on 29 Oct 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
Methoxy Polyethylene Glycol-epoetin Beta	1,085	245

Primary outcome: Hemoglobin Levels at Monthly Intervals

Time frame: Prior to Day 1, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24. Mean (Standard Deviation). Unit: g/dL

Measure	Methoxy Polyethylene Glycol-epoetin Beta n = 926
Prior to Day 1 (n=926)	11.15 (1.21)
Month 1 (Day 1-45) (n=802)	11.31 (1.24)
Month 2 (Day 46-75) (n=715)	11.33 (1.23)
Month 3 (Day 76-105) (n=684)	11.28 (1.32)
Month 4 (Day 106-135) (n=685)	11.28 (1.25)
Month 5 (Day 136-165) (n=602)	11.25 (1.22)
Month 6 (Day 166-195) (n=580)	11.36 (1.27)
Month 7 (Day 196-225) (n=541)	11.30 (1.26)

Population analysed: Effectiveness Population I: all participants for whom at least 1 hemoglobin value was documented after the first application of methoxy polyethylene glycol-epoetin beta during the study course. N (number of participants analyzed) = participants evaluable for this measure. n = participants with hemoglobin values during study period considered.

Primary outcome: Percentage of Participants Within Pre-defined Range of Hemoglobin Values

Time frame: Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24. Number. Unit: percentage of participants

Measure	Methoxy Polyethylene Glycol-epoetin Beta n = 802
11-12 g/dL: Month 1 (Day 1-45) (n=802)	37.5
10-12 g/dL: Month 1 (Day 1-45) (n=802)	61.6
11-13 g/dL: Month 1 (Day 1-45) (n=802)	56.0
10-13 g/dL: Month 1 (Day 1-45) (n=802)	80.0
11-12 g/dL: Month 2 (Day 46-75) (n=715)	39.0
10-12 g/dL: Month 2 (Day 46-75) (n=715)	62.2
11-13 g/dL: Month 2 (Day 46-75) (n=715)	58.2
10-13 g/dL: Month 2 (Day 46-75) (n=715)	81.4

Population analysed: Effectiveness Population I. N (number of participants analyzed) = participants evaluable for this measure. n = participants with hemoglobin values during study period considered.

Primary outcome: Average Methoxy Polyethylene Glycol-epoetin Beta Dose

Time frame: Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24. Mean (Standard Deviation). Unit: microgram (mcg)

Measure	Methoxy Polyethylene Glycol-epoetin Beta n = 933
Month 1 (Day 1-45) (n=933)	103.23 (68.23)
Month 2 (Day 46-75) (n=797)	102.27 (70.96)
Month 3 (Day 76-105) (n=785)	102.48 (71.23)
Month 4 (Day 106-135) (n=758)	102.64 (70.88)
Month 5 (Day 136-165) (n=700)	104.55 (74.81)
Month 6 (Day 166-195) (n=673)	102.87 (76.01)
Month 7 (Day 196-225) (n=631)	101.08 (77.76)
Month 8 (Day 226-255) (n=562)	103.13 (77.41)

Population analysed: Effectiveness Population I. N (number of participants analyzed) = participants evaluable for this measure. n = participants with methoxy polyethylene glycol-epoetin beta dose values during study period considered.

Adverse events

Time frame: Day 1 up to Month 24. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Methoxy Polyethylene Glycol-epoetin Beta	172 of 978 (17.6%)	120 of 978 (12.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Clinical Trials study director

Hoffmann-La Roche

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

Questions about this trial

What is this clinical trial studying?

An observational study of Anemia, run by Hoffmann-La Roche at 1 site in Germany.

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 3 inclusion and 1 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 Nov 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 Germany. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Oct 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?

Hemoglobin Levels at Monthly Intervals (time frame: Prior to Day 1, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24). The study lists 3 primary outcomes in all. 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 NCT01309269.

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 Nov 2016.