Renal Anemia of Chronic Kidney DiseaseNCT02540213

Observational Study of MIRCERA in Users of Self-Application and Multidose Systems

An observational study of Renal Anemia of Chronic Kidney Disease, 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.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Renal Anemia of Chronic Kidney Disease
What is being tested?: MIRCERA
Type of treatment: Medical device
How many people: 240 participants
Where: 1 siteGermany
Study dates: Jan 2009to Nov 2010
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: Participants with chronic kidney disease who received ESA therapy or multidose system before they changed to MIRCERA

Who may be able to join

Anemia caused by CKD only
Life expectancy of more than (>) 9 months in the judgment of the attending physician
Ferritin >200 micrograms per liter (mcg/L) in accordance with the relevant guidelines
The time point of changing to Mircera was only 3 months ago at the longest

Who cannot join

Trial locations and contacts

1 site in 1 country.

Germany1 site

Study site
Daun, 54550

Other trials in Germany

About this study

This non-interventional, observational study investigates the efficiency, safety and acceptance of MIRCERA in participants, who received erythropoiesis stimulating agent (ESA) using a self-application system. For each participant, the investigator documents 9 months of treatment with Mircera with respect to efficacy, safety and acceptance.

Conditions: Renal Anemia of Chronic Kidney Disease
Being tested: MIRCERA

What participants receive

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

MIRCERADevice
Methoxy polyethylene glycol epoetin beta (0.6 mcg/kg q2w) will be administered using MIRCERA ready-to-use-syringes up to 9 months.

Study groups in NCT02540213
Study group	Role	What they receive
MIRCERA Ready-To-Use-Syringe		Participants will use MIRCERA ready-to-use-syringes (methoxy polyethylene glycol epoetin beta 0.6 micrograms per kilogram [mcg/kg]) every 2 weeks (q2w) up to 9 months Receives: Device: MIRCERA

What is being measured

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

Percentage of Participants Satisfied With Previous Erythropoiesis Stimulating Agent (ESA) Treatment
Participant satisfaction was measured using 3 categories (1=satisfying, 2=undecided, 3=non- satisfying). Percentage of participants who were satisfied (with a rating of 1 [satisfying]) with previous ESA treatment was reported. For participants who had multiple previous ESA treatments, the latest applied ESA before start of Mircera therapy was considered.
Measured: Baseline
Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 1
Participant satisfaction was measured using 3 categories (1=satisfying, 2=undecided, 3=non-satisfying). Percentage of participants who were satisfied (with a rating of 1 [satisfying]) was reported for each of the MIRCERA parameters.
Measured: Month 1
Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 2
Participant satisfaction was measured using 3 categories (1=satisfying, 2=undecided, 3=non-satisfying). Percentage of participants who were satisfied (with a rating of 1 [satisfying]) was reported for each of the MIRCERA parameters.
Measured: Month 2
Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 3
Participant satisfaction was measured using 3 categories (1=satisfying, 2=undecided, 3=non-satisfying). Percentage of participants who were satisfied (with a rating of 1 [satisfying]) was reported for each of the MIRCERA parameters.
Measured: Month 3
Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 4
Participant satisfaction was measured using 3 categories (1=satisfying, 2=undecided, 3=non-satisfying). Percentage of participants who were satisfied (with a rating of 1 [satisfying]) was reported for each of the MIRCERA parameters.
Measured: Month 4
Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 5
Participant satisfaction was measured using 3 categories (1=satisfying, 2=undecided, 3=non-satisfying). Percentage of participants who were satisfied (with a rating of 1 [satisfying]) was reported for each of the MIRCERA parameters.
Measured: Month 5
Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 6
Participant satisfaction was measured using 3 categories (1=satisfying, 2=undecided, 3=non-satisfying). Percentage of participants who were satisfied (with a rating of 1 [satisfying]) was reported for each of the MIRCERA parameters.
Measured: Month 6
Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 7
Participant satisfaction was measured using 3 categories (1=satisfying, 2=undecided, 3=non-satisfying). Percentage of participants who were satisfied (with a rating of 1 [satisfying]) was reported for each of the MIRCERA parameters.
Measured: Month 7
Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 8
Participant satisfaction was measured using 3 categories (1=satisfying, 2=undecided, 3=non-satisfying). Percentage of participants who were satisfied (with a rating of 1 [satisfying]) was reported for each of the MIRCERA parameters.
Measured: Month 8
Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 9
Participant satisfaction was measured using 3 categories (1=satisfying, 2=undecided, 3=non-satisfying). Percentage of participants who were satisfied (with a rating of 1 [satisfying]) was reported for each of the MIRCERA parameters.
Measured: Month 9
Change From Baseline in Pain Sensation Using Visual Analogue Scale
Pain sensation was reported by participants using a visual scale ranging from 0 (no pain) to 10 (strong pain). Pain sensation at baseline referred to pain sensation regarding previous ESA. Change of pain sensation = pain sensation regarding previous ESA (baseline)' minus 'pain sensation regarding MIRCERA (Month 1-9). Positive numbers indicate less pain sensation during MIRCERA application.
Measured: Baseline, Months 1-9
Percentage of Participants Who Reported Easement of Therapy With MIRCERA
Measured: 9 months
Percentage of Participants Who Continued Treatment After End of Study
Measured: End of observation period (Month 9)
Average Monthly Dose of MIRCERA
Measured: 9 months
Number of MIRCERA Dose Adaptations
Measured: 9 months
Mean Monthly Administrations of MIRCERA
Measured: 9 months
Percentage of Participants With Pre-Post Shift for Participant Satisfaction With Treatment
Participant satisfaction with treatment was measured using 3 categories (1=satisfying, 2=undecided, 3=non-satisfying). Participant pre-post comparison of satisfaction rating was done by considering the difference of baseline rating (satisfaction rating for previous ESA) and rating at respective visit (satisfaction rating for MIRCERA). Thus, possible results were -2, -1, 0, 1, and 2, with positive values indicating a greater satisfaction with MIRCERA than with the previous ESA (acceptance and preference of MIRCERA over previous ESA). Percentage of participants with each possible result category (-2, -1, 0, 1, 2) is reported at each visit.
Measured: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9

Secondary outcomes (1)

Change From Baseline in Hemoglobin (Hb) Concentration
Measured: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9

Timeline

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

Jan 2009Nov 2010

First posted3 Sep 2015 (estimated)
Study startJan 2009
Primary completionNov 2010
Study completionNov 2010

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 Renal Anemia of Chronic Kidney DiseaseStudies 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: 240 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02540213
Sponsor's protocol ID: ML21387
Status last verified: Nov 2015
First submitted: 1 Sep 2015
Last updated: 22 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 Renal Anemia of Chronic Kidney Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Observational Study of MIRCERA in Users of Self-Application and Multidose Systems
ClinicalTrials.gov ID: NCT02540213
Acronym / sponsor ID: ML21387
Conditions: Renal Anemia of Chronic Kidney Disease
Study type: Observational
Recruitment status: Completed
Enrolment: 240 participants (actual)
Lead sponsor: Hoffmann-La RocheIndustry (pharma, biotech, devices)
Study start: Jan 2009
Primary completion: Nov 2010 (actual)
Study completion: Nov 2010 (actual)
First posted: 3 Sep 2015 (estimated)
Results: Posted 22 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
MIRCERA Ready-To-Use-Syringe	–	Device: MIRCERAParticipants will use MIRCERA ready-to-use-syringes (methoxy polyethylene glycol epoetin beta 0.6 micrograms per kilogram [mcg/kg]) every 2 weeks (q2w) up to 9 months

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Participants with chronic kidney disease who received ESA therapy or multidose system before they changed to MIRCERA

Key inclusion criteria (4 listed)

Anemia caused by CKD only
Life expectancy of more than (>) 9 months in the judgment of the attending physician
Ferritin >200 micrograms per liter (mcg/L) in accordance with the relevant guidelines
The time point of changing to Mircera was only 3 months ago at the longest

Key exclusion criteria (1 listed)

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
MIRCERAMethoxy polyethylene glycol epoetin beta (0.6 mcg/kg q2w) will be administered using MIRCERA ready-to-use-syringes up to 9 months.	Device	MIRCERA Ready-To-Use-Syringe

Primary outcome

Percentage of Participants Satisfied With Previous Erythropoiesis Stimulating Agent (ESA) Treatment
Time frame: Baseline
Participant satisfaction was measured using 3 categories (1=satisfying, 2=undecided, 3=non- satisfying). Percentage of participants who were satisfied (with a rating of 1 [satisfying]) with previous ESA treatment was reported. For participants who had multiple previous ESA treatments, the latest applied ESA before start of Mircera therapy was considered.
Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 1
Time frame: Month 1
Participant satisfaction was measured using 3 categories (1=satisfying, 2=undecided, 3=non-satisfying). Percentage of participants who were satisfied (with a rating of 1 [satisfying]) was reported for each of the MIRCERA parameters.
Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 2
Time frame: Month 2
Participant satisfaction was measured using 3 categories (1=satisfying, 2=undecided, 3=non-satisfying). Percentage of participants who were satisfied (with a rating of 1 [satisfying]) was reported for each of the MIRCERA parameters.
Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 3
Time frame: Month 3
Participant satisfaction was measured using 3 categories (1=satisfying, 2=undecided, 3=non-satisfying). Percentage of participants who were satisfied (with a rating of 1 [satisfying]) was reported for each of the MIRCERA parameters.
Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 4
Time frame: Month 4
Participant satisfaction was measured using 3 categories (1=satisfying, 2=undecided, 3=non-satisfying). Percentage of participants who were satisfied (with a rating of 1 [satisfying]) was reported for each of the MIRCERA parameters.
Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 5
Time frame: Month 5
Participant satisfaction was measured using 3 categories (1=satisfying, 2=undecided, 3=non-satisfying). Percentage of participants who were satisfied (with a rating of 1 [satisfying]) was reported for each of the MIRCERA parameters.
Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 6
Time frame: Month 6
Participant satisfaction was measured using 3 categories (1=satisfying, 2=undecided, 3=non-satisfying). Percentage of participants who were satisfied (with a rating of 1 [satisfying]) was reported for each of the MIRCERA parameters.
Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 7
Time frame: Month 7
Participant satisfaction was measured using 3 categories (1=satisfying, 2=undecided, 3=non-satisfying). Percentage of participants who were satisfied (with a rating of 1 [satisfying]) was reported for each of the MIRCERA parameters.
Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 8
Time frame: Month 8
Participant satisfaction was measured using 3 categories (1=satisfying, 2=undecided, 3=non-satisfying). Percentage of participants who were satisfied (with a rating of 1 [satisfying]) was reported for each of the MIRCERA parameters.
Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 9
Time frame: Month 9
Participant satisfaction was measured using 3 categories (1=satisfying, 2=undecided, 3=non-satisfying). Percentage of participants who were satisfied (with a rating of 1 [satisfying]) was reported for each of the MIRCERA parameters.
Change From Baseline in Pain Sensation Using Visual Analogue Scale
Time frame: Baseline, Months 1-9
Pain sensation was reported by participants using a visual scale ranging from 0 (no pain) to 10 (strong pain). Pain sensation at baseline referred to pain sensation regarding previous ESA. Change of pain sensation = pain sensation regarding previous ESA (baseline)' minus 'pain sensation regarding MIRCERA (Month 1-9). Positive numbers indicate less pain sensation during MIRCERA application.
Percentage of Participants Who Reported Easement of Therapy With MIRCERA
Time frame: 9 months
Percentage of Participants Who Continued Treatment After End of Study
Time frame: End of observation period (Month 9)
Average Monthly Dose of MIRCERA
Time frame: 9 months
Number of MIRCERA Dose Adaptations
Time frame: 9 months
Mean Monthly Administrations of MIRCERA
Time frame: 9 months
Percentage of Participants With Pre-Post Shift for Participant Satisfaction With Treatment
Time frame: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9
Participant satisfaction with treatment was measured using 3 categories (1=satisfying, 2=undecided, 3=non-satisfying). Participant pre-post comparison of satisfaction rating was done by considering the difference of baseline rating (satisfaction rating for previous ESA) and rating at respective visit (satisfaction rating for MIRCERA). Thus, possible results were -2, -1, 0, 1, and 2, with positive values indicating a greater satisfaction with MIRCERA than with the previous ESA (acceptance and preference of MIRCERA over previous ESA). Percentage of participants with each possible result category (-2, -1, 0, 1, 2) is reported at each visit.

1 secondary outcome

Change From Baseline in Hemoglobin (Hb) Concentration
Time frame: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9

Results and safety

Results posted to the registry on 22 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
MIRCERA	240	201

Primary outcome: Percentage of Participants Satisfied With Previous Erythropoiesis Stimulating Agent (ESA) Treatment

Time frame: Baseline. Number. Unit: percentage of participants

Measure	MIRCERA n = 221
Value	83.7

Population analysed: Participant Satisfaction Set included all participants who had at least one MIRCERA application, without any major protocol violation and had satisfaction rating documented for previous ESA and MIRCERA.

Primary outcome: Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 1

Time frame: Month 1. Number. Unit: percentage of participants

Measure	MIRCERA n = 221
Treatment	93.7
Application	93.7
Preparation	95.9
Storage	96.8
Disposal	92.3

Population analysed: Participant Satisfaction Set.

Primary outcome: Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 2

Time frame: Month 2. Number. Unit: percentage of participants

Measure	MIRCERA n = 218
Treatment	93.6
Application	92.7
Preparation	96.8
Storage	96.8
Disposal	92.2

Population analysed: Participant Satisfaction Set. Here number of participants analyzed (N) = participants who were evaluable for this outcome measure.

Primary outcome: Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 3

Time frame: Month 3. Number. Unit: percentage of participants

Measure	MIRCERA n = 218
Treatment	93.9
Application	91.5
Preparation	94.4
Storage	94.4
Disposal	89.7

Population analysed: Participant Satisfaction Set. Here N = participants who were evaluable for this outcome measure.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: up to the end of study (9 months). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MIRCERA	27 of 238 (11.3%)	9 of 238 (3.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 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 Renal Anemia of Chronic Kidney Disease, 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 4 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 22 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 22 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 Satisfied With Previous Erythropoiesis Stimulating Agent (ESA) Treatment (time frame: Baseline). The study lists 17 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 NCT02540213.

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 22 Dec 2015.