AnemiaNCT01051323

An Observational Study of Mircera (Methoxy Polyethylene Glycol-epoetin Beta) in Patients With Renal Anemia

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 investigate hemoglobin levels and Mircera (methoxy polyethyleneglycol-epoetin beta) dose over time in patients with chronic kidney disease, and compare standards of care between centers. Data from each patient will be collected over 12 months of Mircera therapy. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Anemia
What is being tested?: methoxy polyethylene glycol-ep [Mircera]
How many people: 1,580 participants
Where: 1 siteGermany
Study dates: Mar 2010to Feb 2013
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: CKD patients treated with Mirecera at different medical centers

Who may be able to join

adult patients, >/= 18 years of age
chronic kidney disease
informed consent for data transmission

Who cannot join

serious hematological or infectious disease
acute bleeding in the 16 weeks preceding data collection
participation in an interventional trial
female patients: pregnancy or breast-feeding

Trial locations and contacts

1 site in 1 country.

Germany1 site

Study site
Saarlouis, 66740

Other trials in Germany

About this study

Official title: Non-interventional Study to Investigate Hemoglobin Levels and Dose Over Time in the Daily Use of Mircera for Renal Anemia in Larger Centers, and to Detect Differences Between Standard of Care in the Centers

Conditions: Anemia
Being tested: methoxy polyethylene glycol-ep [Mircera]
Medical subject headings: Anemia

What participants receive

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

methoxy polyethylene glycol-ep [Mircera]Drug
As prescribed by physician

Study groups in NCT01051323
Study group	Role	What they receive
1		Not described Receives: Drug: methoxy polyethylene glycol-ep [Mircera]

What is being measured

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

Percentage of Participants With at Least One Hemoglobin Value Outside the Target Range
Mean hemoglobin was calculated from measurements taken during the Evaluation Period (Month 0 to Month 12). The target hemoglobin range was 10 to 13 gram/deciliter (g/dL). Percentage of participants with at least one hemoglobin value less than (<) 10 g/dL or greater than (>) 13 g/dL during the evaluation period by predialysis/hemodialysis is presented.
Measured: Month 0 to Month 12
Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Evaluation Period by Dose Modification, Age, and Center Size
The percentage of participants with hemoglobin (Hb) values within the pre-defined ranges (10-12 g/dL, 11-12 g/dL, and 11-13 g/dL) during evaluation period (Month 0 to Month 12) by dose modification (yes or no), age (<65 years, greater than or equal to [>=] 65 years) and center size (>100 participants, less than or equal to [<=] 100 participants) is presented.
Measured: Month 0 to Month 12
Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Month 6 to Month 12 by Dose Modification, Age, and Center Size
The percentage of participants with hemoglobin values within the pre-defined ranges (10-12 g/dL, 11-12 g/dL, and 11-13 g/dL) during Month 6 to Month 12 by dose modification (yes or no), age (<65 years, >=65 years) and center size (>100 participants, <=100 participants) is presented.
Measured: Month 6 to Month 12
Maximum Intra-Individual Fluctuation of Hemoglobin Values by Predialysis/Hemodialysis, Age, and Center Size
For characterization of intra-individual fluctuations, the maximum absolute differences were derived from study period specific individual mean values. Maximum intra-individual fluctuation of hemoglobin values by predialysis/hemodialysis, age (<65 years, >=65 years), and center size (>100 participants, <=100 participants) is presented. Data for this outcome measure was reported for overall participants.
Measured: Month 0 to Month 12
Serum Ferritin Values
Serum ferritin levels were measured as nanogram/milliliter (ng/mL). Data for this outcome measure was reported for overall participants.
Measured: Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12
Serum Iron Values
Serum iron levels were measured as microgram/deciliter (mcg/dL). Data for this outcome measure was reported for overall participants.
Measured: Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12
Transferrin Values
Transferrin levels were measured as milligram/deciliter (mg/dL). Data for this outcome measure was reported for overall participants.
Measured: Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12
Transferrin Saturation Values
Transferrin saturation (TSAT) measured as a percentage, is a medical laboratory test. It is the ratio of serum iron and total iron-binding capacity, multiplied by 100. Data for this outcome measure was reported for overall participants.
Measured: Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12
C-reactive Protein (CRP) Values
The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. Data for this outcome measure was reported for overall participants.
Measured: Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12
Number of Physicians Satisfied With Treatment at Final Visit
Physicians were asked to rate their satisfaction with the methoxy polyethyleneglycol-epoetin beta treatment at final visit. Physicians' responses were "very satisfied", "satisfied", "undecided", or "not satisfied". One physician could analyze multiple participants but for the purpose of analysis each physician was counted as one for each analyzed participants; hence, the number of physicians (as per this assessment) was equal to the number of participants analyzed. Data for this outcome measure was reported for overall participants.
Measured: Month 12 or early discontinuation
Number of Participants Who Continued Treatment With Methoxy Polyethyleneglycol-epoetin Beta After Study Completion
At final visit, physicians were asked to answer ("yes" or "no") the question, whether they would continue treatment with methoxy polyethyleneglycol-epoetin beta treatment after study completion. Data for this outcome measure was reported for overall participants.
Measured: Month 12 or early discontinuation
Number of Participants With Reasons for Discontinuation of Methoxy Polyethyleneglycol-epoetin Beta Treatment After Study Completion
At final visit, physicians were asked to state the reasons in case of discontinuation of treatment with methoxy polyethyleneglycol-epoetin beta. The same participant could have discontinued treatment due to multiple reasons. Data for this outcome measure was reported for overall participants.
Measured: Month 12 or early discontinuation
Number of Participants Who Switched to Other Erythropoiesis Stimulating Agents (ESA)-Therapy
Number of participants who switched to other ESA therapies including Aranesp, Biopoin, Biosimilar, Erypo, and NeoRecormon is presented. Data for this outcome measure was reported for overall participants.
Measured: Month 12 or early discontinuation
Number of Participants Satisfied With Treatment at Final Visit
Participants were asked to rate their satisfaction with methoxy polyethyleneglycol-epoetin beta treatment at final visit. Participants' responses were "very satisfied", "satisfied", "undecided", or "not satisfied". Data for this outcome measure was reported for overall participants.
Measured: Month 12 or early discontinuation

Secondary outcomes (1)

Average Methoxy Polyethylene Glycol-epoetin Beta Dose
Average methoxy polyethylene glycol-epoetin beta dose per application is presented by study month. Mean values were taken when more than 1 application was documented for a participant during the time period considered. Data for this outcome measure was reported for overall participants.
Measured: Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12

Timeline

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

Mar 2010Feb 2013

First posted18 Jan 2010 (estimated)
Study startMar 2010
Primary completionFeb 2013
Study completionFeb 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 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: 1,580 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01051323
Sponsor's protocol ID: ML22714
Status last verified: Nov 2015
First submitted: 15 Jan 2010
Last updated: 18 Dec 2015
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 18 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Non-interventional Study to Investigate Hemoglobin Levels and Dose Over Time in the Daily Use of Mircera for Renal Anemia in Larger Centers, and to Detect Differences Between Standard of Care in the Centers
ClinicalTrials.gov ID: NCT01051323
Acronym / sponsor ID: ML22714
Conditions: Anemia
Study type: Observational
Recruitment status: Completed
Enrolment: 1,580 participants (actual)
Lead sponsor: Hoffmann-La RocheIndustry (pharma, biotech, devices)
Study start: Mar 2010
Primary completion: Feb 2013 (actual)
Study completion: Feb 2013 (actual)
First posted: 18 Jan 2010 (estimated)
Results: Posted 18 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

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

Arm	Type	Receives
1	–	Drug: methoxy polyethylene glycol-ep [Mircera]

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: CKD patients treated with Mirecera at different medical centers

Key inclusion criteria (3 listed)

adult patients, >/= 18 years of age
chronic kidney disease
informed consent for data transmission

Key exclusion criteria (4 listed)

serious hematological or infectious disease
acute bleeding in the 16 weeks preceding data collection
participation in an interventional trial
female patients: pregnancy or breast-feeding

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
methoxy polyethylene glycol-ep [Mircera]As prescribed by physician	Drug	1

Primary outcome

Percentage of Participants With at Least One Hemoglobin Value Outside the Target Range
Time frame: Month 0 to Month 12
Mean hemoglobin was calculated from measurements taken during the Evaluation Period (Month 0 to Month 12). The target hemoglobin range was 10 to 13 gram/deciliter (g/dL). Percentage of participants with at least one hemoglobin value less than (<) 10 g/dL or greater than (>) 13 g/dL during the evaluation period by predialysis/hemodialysis is presented.
Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Evaluation Period by Dose Modification, Age, and Center Size
Time frame: Month 0 to Month 12
The percentage of participants with hemoglobin (Hb) values within the pre-defined ranges (10-12 g/dL, 11-12 g/dL, and 11-13 g/dL) during evaluation period (Month 0 to Month 12) by dose modification (yes or no), age (<65 years, greater than or equal to [>=] 65 years) and center size (>100 participants, less than or equal to [<=] 100 participants) is presented.
Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Month 6 to Month 12 by Dose Modification, Age, and Center Size
Time frame: Month 6 to Month 12
The percentage of participants with hemoglobin values within the pre-defined ranges (10-12 g/dL, 11-12 g/dL, and 11-13 g/dL) during Month 6 to Month 12 by dose modification (yes or no), age (<65 years, >=65 years) and center size (>100 participants, <=100 participants) is presented.
Maximum Intra-Individual Fluctuation of Hemoglobin Values by Predialysis/Hemodialysis, Age, and Center Size
Time frame: Month 0 to Month 12
For characterization of intra-individual fluctuations, the maximum absolute differences were derived from study period specific individual mean values. Maximum intra-individual fluctuation of hemoglobin values by predialysis/hemodialysis, age (<65 years, >=65 years), and center size (>100 participants, <=100 participants) is presented. Data for this outcome measure was reported for overall participants.
Serum Ferritin Values
Time frame: Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12
Serum ferritin levels were measured as nanogram/milliliter (ng/mL). Data for this outcome measure was reported for overall participants.
Serum Iron Values
Time frame: Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12
Serum iron levels were measured as microgram/deciliter (mcg/dL). Data for this outcome measure was reported for overall participants.
Transferrin Values
Time frame: Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12
Transferrin levels were measured as milligram/deciliter (mg/dL). Data for this outcome measure was reported for overall participants.
Transferrin Saturation Values
Time frame: Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12
Transferrin saturation (TSAT) measured as a percentage, is a medical laboratory test. It is the ratio of serum iron and total iron-binding capacity, multiplied by 100. Data for this outcome measure was reported for overall participants.
C-reactive Protein (CRP) Values
Time frame: Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12
The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. Data for this outcome measure was reported for overall participants.
Number of Physicians Satisfied With Treatment at Final Visit
Time frame: Month 12 or early discontinuation
Physicians were asked to rate their satisfaction with the methoxy polyethyleneglycol-epoetin beta treatment at final visit. Physicians' responses were "very satisfied", "satisfied", "undecided", or "not satisfied". One physician could analyze multiple participants but for the purpose of analysis each physician was counted as one for each analyzed participants; hence, the number of physicians (as per this assessment) was equal to the number of participants analyzed. Data for this outcome measure was reported for overall participants.
Number of Participants Who Continued Treatment With Methoxy Polyethyleneglycol-epoetin Beta After Study Completion
Time frame: Month 12 or early discontinuation
At final visit, physicians were asked to answer ("yes" or "no") the question, whether they would continue treatment with methoxy polyethyleneglycol-epoetin beta treatment after study completion. Data for this outcome measure was reported for overall participants.
Number of Participants With Reasons for Discontinuation of Methoxy Polyethyleneglycol-epoetin Beta Treatment After Study Completion
Time frame: Month 12 or early discontinuation
At final visit, physicians were asked to state the reasons in case of discontinuation of treatment with methoxy polyethyleneglycol-epoetin beta. The same participant could have discontinued treatment due to multiple reasons. Data for this outcome measure was reported for overall participants.
Number of Participants Who Switched to Other Erythropoiesis Stimulating Agents (ESA)-Therapy
Time frame: Month 12 or early discontinuation
Number of participants who switched to other ESA therapies including Aranesp, Biopoin, Biosimilar, Erypo, and NeoRecormon is presented. Data for this outcome measure was reported for overall participants.
Number of Participants Satisfied With Treatment at Final Visit
Time frame: Month 12 or early discontinuation
Participants were asked to rate their satisfaction with methoxy polyethyleneglycol-epoetin beta treatment at final visit. Participants' responses were "very satisfied", "satisfied", "undecided", or "not satisfied". Data for this outcome measure was reported for overall participants.

1 secondary outcome

Average Methoxy Polyethylene Glycol-epoetin Beta Dose
Time frame: Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12

Results and safety

Results posted to the registry on 18 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
Methoxy Polyethylene Glycol-epoetin Beta (All Participants)	1,580	1,041

Primary outcome: Percentage of Participants With at Least One Hemoglobin Value Outside the Target Range

Time frame: Month 0 to Month 12. Number. Unit: percentage of participants

Measure	Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) n = 326	Methoxy Polyethylene Glycol-epoetin Beta (Hemodialysis) n = 1184
Hemoglobin value <10 g/dL	97.9	72.9
Hemoglobin value >13 g/dL	33.7	35.3

Population analysed: FAS

Primary outcome: Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Evaluation Period by Dose Modification, Age, and Center Size

Time frame: Month 0 to Month 12. Number. Unit: percentage of participants

Measure	Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) n = 326	Methoxy Polyethylene Glycol-epoetin Beta (Hemodialysis) n = 1184
No dose modifications: Hb 10-12 g/dL (n=157, 242)	11.5	8.7
No dose modifications: Hb 11-12 g/dL (n=157, 242)	0.6	0.8
No dose modifications: Hb 11-13 g/dL (n=157, 242)	11.5	11.2
With dose modifications: Hb 10-12g/dL (n=169, 942)	6.5	4.9
With dose modifications: Hb 11-12g/dL (n=169, 942)	0.6	0.1
With dose modifications: Hb 11-13g/dL (n=169, 942)	8.9	5.2
Age <65 years: Hb 10-12 g/dL (n=70, 402)	10.0	6.7
Age <65 years: Hb 11-12 g/dL (n=70, 402)	1.4	0.5

Population analysed: FAS. n = participants evaluable for specified category for each arm group, respectively.

Primary outcome: Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Month 6 to Month 12 by Dose Modification, Age, and Center Size

Time frame: Month 6 to Month 12. Number. Unit: percentage of participants

Measure	Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) n = 326	Methoxy Polyethylene Glycol-epoetin Beta (Hemodialysis) n = 1184
No dose modifications: Hb 10-12 g/dL (n=157, 242)	9.6	12.8
No dose modifications: Hb 11-12 g/dL (n=157, 242)	3.2	2.5
No dose modifications: Hb 11-13 g/dL (n=157, 242)	8.3	12.8
With dose modifications: Hb 10-12g/dL (n=169, 942)	10.7	14.6
With dose modifications: Hb 11-12g/dL (n=169, 942)	1.2	2.3
With dose modifications: Hb 11-13g/dL (n=169, 942)	9.5	15.1
Age <65 years: Hb 10-12 g/dL (n=70, 402)	11.4	14.7
Age <65 years: Hb 11-12 g/dL (n=70, 402)	4.3	3.0

Population analysed: FAS. n = participants evaluable for specified category for each arm group, respectively.

Primary outcome: Maximum Intra-Individual Fluctuation of Hemoglobin Values by Predialysis/Hemodialysis, Age, and Center Size

Time frame: Month 0 to Month 12. Mean (Standard Deviation). Unit: g/dL

Measure	Methoxy Polyethylene Glycol-epoetin Beta (All Participants) n = 1489
Predialysis (n=317)	1.3 (0.8)
Hemodialysis (n=1172)	1.6 (0.8)
Age <65 years (n=467)	1.6 (0.8)
Age >=65 years (n=1022)	1.5 (0.8)
Center size >100 participants (n=654)	1.5 (0.8)
Center size <=100 participants (n=835)	1.6 (0.8)

Population analysed: FAS. N (number of participants analyzed) = participants evaluable for this measure. n = participants evaluable for specified category.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Month 0 to Month 12. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Methoxy Polyethylene Glycol-epoetin Beta (Predialysis)	7 of 346 (2%)	13 of 346 (3.8%)	Not reported
Methoxy Polyethylene Glycol-epoetin Beta (Hemodialysis)	67 of 1,201 (5.6%)	196 of 1,201 (16.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2015.
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 4 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 18 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 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 18 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?

Percentage of Participants With at Least One Hemoglobin Value Outside the Target Range (time frame: Month 0 to Month 12). The study lists 14 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 NCT01051323.

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 18 Dec 2015.