AnemiaNCT02567188

A Study of MIRCERA in Participants With Chronic Kidney Disease Stage 3-4 and Not on Dialysis

An observational study of Anemia, run by Hoffmann-La Roche at 20 sites in Sweden.

Completed

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

Trial summary

An observational, longitudinal, multi-center, non-interventional study in participants with chronic kidney disease (CKD) stage 3-4, assessed by Modification of Diet in Renal Disease (MDRD) to collect data regarding safety and efficacy in participants with pre-dialysis situation who are treated with MIRCERA in normal… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Anemia
What is being tested?: MIRCERA
How many people: 144 participants
Where: 20 sitesSweden
Study dates: Apr 2009to Apr 2011
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: Adult participants with CKD Stage 3-4 treated with MIRCERA

Who may be able to join

Adult participants above 18 years of age
Pre-dialysis participants with CKD stage 3-4 treated with MIRCERA and continue in the pre-dialysis state for the whole study period
Estimated glomerular filteration rate (e-GFR) between 15-60 milliliter per minute (mL/min) (calculated)

Who cannot join

Participants involved in interventional trials
Participants with life expectancy less than 1 year
Active malignancy
Planned living kidney transplant within 6 months.

Trial locations and contacts

20 sites in 1 country.

City, postcode or hospital

20 sites in 1 country

Sweden20 sites

Study site
Angeholm, S-262 81
Study site
Bollnäs, 821 81
Study site
Eskilstuna, 63188
Study site
Gävle, 80187
Study site
Gothenburg, 41345
Study site
Gothenburg, S-402 76
Study site
Huddinge, 14186
Study site
Jönköping, 55185
Study site
Karlshamn, S-374 80
Study site
Karlstad, 65185
Study site
Kristianstad, 29185
Study site
Linköping, S-581 85
Study site
Mölndal, S-431 80
Study site
Norrköping, 60182
Study site
Skövde, 54185
Study site
Stockholm, 17176
Study site
Stockholm, 18288
Study site
Umeå, 90185
Study site
Värnamo, 33185
Study site
Västervik, 59381

Other trials in Sweden

About this study

Conditions: Anemia
Being tested: MIRCERA
Medical subject headings: Anemia

What participants receive

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

MIRCERAOther

Study groups in NCT02567188
Study group	Role	What they receive
Cohort of CKD Participants		Pre-dialysis participants with CKD treated with MIRCERA according to the current standard of care and in line with the current local summary of product characteristics were observed for maximum of 12 months. Receives: Other: MIRCERA

What is being measured

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

Percentage of Participants Reaching a Hemoglobin (Hb) Value of Greater Than (>) 100 and Less Than (<) 120 Grams Per Liter (gm/L) at Month 6 Before Inclusion
Measured: Pre-baseline (Month -6)
Percentage of Participants Reaching a Hb Value of >100 and < 120 gm/L at Month 3 Before Inclusion
Measured: Pre-baseline (Month -3)
Percentage of Participants Reaching a Hb Value of >100 and < 120 gm/L at Baseline
Measured: Baseline
Percentage of Participants Reaching a Hb Value of > 100 and < 120 gm/L at Month 3 After Inclusion
Measured: Month 3
Percentage of Participants Reaching a Hb Value of > 100 and < 120 gm/L at Month 6 After Inclusion
Measured: Month 6
Percentage of Participants Reaching a Hb Value of > 100 and < 120 gm/L at Month 9 After Inclusion
Measured: Month 9
Percentage of Participants Reaching a Hb Value of > 100 and < 120 gm/L at Month 12 After Inclusion
Measured: Month 12
Mean Hb Value at Month 6 Before Inclusion
Measured: Pre-baseline (Month -6)
Mean Hb Value at Month 3 Before Inclusion
Measured: Pre-baseline (Month -3)
Mean Hb Value at Baseline
Measured: Baseline
Mean Hb Value at Month 3 After Inclusion
Measured: Month 3
Mean Hb Value at Month 6 After Inclusion
Measured: Month 6
Mean Hb Value at Month 9 After Inclusion
Measured: Month 9
Mean Hb Value at Month 12 After Inclusion
Measured: Month 12
Percentage of Participants With Hb Fluctuation From Pre-Baseline (Month -6) to Baseline
Hb fluctuation was defined as change in Hb value >15 gm/L between 2 visits.
Measured: Pre-baseline (Month -6) to Baseline
Percentage of Participants With Hb Fluctuation From Baseline to Month 12
Hb fluctuation was defined as change in Hb value >15 gm/L between 2 visits.
Measured: Baseline to Month 12

Secondary outcomes (10)

Percentage of Participants With Change in MIRCERA Treatment
Change in MIRCERA treatment included changes in dose, frequency, and route of administration.
Measured: Months 3, 6, 9, and 12
Percentage of Participants With Number of MIRCERA Dose Changes
Measured: Baseline to Month 12
Correlation of Hb Levels With Underlying Disease
Measured: Baseline to 12 months
Correlation of Hb Levels With Levels of Inflammation
Measured: Baseline to 12 months
Percentage of Participants With Changes in Iron Supplement
Percentage of participants who had any change in their iron supplement medication at a specified visit were reported.
Measured: Pre-baseline (Months -6 and -3), baseline, Months 3, 6, 9 and 12
Percentage of Participants With Changes in Immunosuppressive Treatment
Percentage of participants who had any change in their immunosuppressive medication at a specified visit were reported.
Measured: Pre-baseline (Months -6 and -3), baseline, Months 3, 6, 9 and 12
Percentage of Participants With Changes in Antihypertensive Treatment
Percentage of participants who had any change in their antihypertensive medication at a specified visit were reported.
Measured: Pre-baseline (Months -6 and -3), baseline, Months 3, 6, 9 and 12
Number of Participants With Different Medication Treatment
Number of participants who were receiving different treatments (antihypertensive, immunosuppressive, iron supplements, and others) before and/or after baseline were reported. Same participant could be reported in more than one category.
Measured: Pre-baseline (Month -6) to Month 12
Percentage of Participants Who Required Blood Transfusion
Measured: Pre-baseline (Months -6 and -3), baseline, Months 3, 6, 9 and 12
Percentage of Participants Who Required Renal Replacement Therapy
Renal replacement therapy was defined as hemodialysis and peritoneal dialysis.
Measured: Months 3, 6, 9, and 12

Timeline

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

Apr 2009Apr 2011

First posted2 Oct 2015 (estimated)
Study startApr 2009
Primary completionApr 2011
Study completionApr 2011

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: Case-control
Time perspective: Cross-sectional
Enrolment: 144 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02567188
Sponsor's protocol ID: ML22439
Status last verified: Aug 2025
First submitted: 28 Sep 2015
Last updated: 11 Sep 2025
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

RecruitingPhase 1/2
The Safety and Efficacy of Daratumumab in Patients With Refractory Aplastic Anemia
Aplastic Anemia, Refractory
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A Study of YTS109 Cell Injection in Subjects With Relapsed/Refractory Autoimmune Hemolytic Anemia
Autoimmune Hemolytic Anemia, Anti-CD19 STAR T-cell Therapy
Not yet recruitingObservational study
Systematic Intraoperative Cell Salvage in On-Pump Cardiac Surgery Within a Mature Patient Blood Management Programme
Cardiac Surgical Procedures, Blood Transfusion
RecruitingPhase 1/2
Pacritinib, a Kinase Inhibitor of CSF1R, IRAK1, JAK2, and FLT3, in Adults and Pediatric Participants 12 Years of Age or Older With Myelodysplastic Syndromes or Myelodysplastic/Myeloproliferative Neoplasms
Myelodysplastic Syndromes
RecruitingObservational study
Defining the Natural History of Squamous Cell Carcinoma in Fanconi Anemia
Fanconi Anemia, Inherited Bone Marrow Failure Syndrome

All Anemia trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study of MIRCERA in Participants With Chronic Kidney Disease Stage 3-4 and Not on Dialysis
ClinicalTrials.gov ID: NCT02567188
Acronym / sponsor ID: ML22439
Conditions: Anemia
Study type: Observational
Recruitment status: Completed
Enrolment: 144 participants (actual)
Lead sponsor: Hoffmann-La RocheIndustry (pharma, biotech, devices)
Study start: Apr 2009
Primary completion: Apr 2011 (actual)
Study completion: Apr 2011 (actual)
First posted: 2 Oct 2015 (estimated)
Results: Posted 30 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: Case-control
Time perspective: Cross-sectional
Number of arms: 1

Arm	Type	Receives
Cohort of CKD Participants	–	Other: MIRCERAPre-dialysis participants with CKD treated with MIRCERA according to the current standard of care and in line with the current local summary of product characteristics were observed for maximum of 12 months.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Adult participants with CKD Stage 3-4 treated with MIRCERA

Key inclusion criteria (3 listed)

Adult participants above 18 years of age
Pre-dialysis participants with CKD stage 3-4 treated with MIRCERA and continue in the pre-dialysis state for the whole study period
Estimated glomerular filteration rate (e-GFR) between 15-60 milliliter per minute (mL/min) (calculated)

Key exclusion criteria (4 listed)

Participants involved in interventional trials
Participants with life expectancy less than 1 year
Active malignancy
Planned living kidney transplant within 6 months.

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
MIRCERA	Other	Cohort of CKD Participants

Primary outcome

Percentage of Participants Reaching a Hemoglobin (Hb) Value of Greater Than (>) 100 and Less Than (<) 120 Grams Per Liter (gm/L) at Month 6 Before Inclusion
Time frame: Pre-baseline (Month -6)
Percentage of Participants Reaching a Hb Value of >100 and < 120 gm/L at Month 3 Before Inclusion
Time frame: Pre-baseline (Month -3)
Percentage of Participants Reaching a Hb Value of >100 and < 120 gm/L at Baseline
Time frame: Baseline
Percentage of Participants Reaching a Hb Value of > 100 and < 120 gm/L at Month 3 After Inclusion
Time frame: Month 3
Percentage of Participants Reaching a Hb Value of > 100 and < 120 gm/L at Month 6 After Inclusion
Time frame: Month 6
Percentage of Participants Reaching a Hb Value of > 100 and < 120 gm/L at Month 9 After Inclusion
Time frame: Month 9
Percentage of Participants Reaching a Hb Value of > 100 and < 120 gm/L at Month 12 After Inclusion
Time frame: Month 12
Mean Hb Value at Month 6 Before Inclusion
Time frame: Pre-baseline (Month -6)
Mean Hb Value at Month 3 Before Inclusion
Time frame: Pre-baseline (Month -3)
Mean Hb Value at Baseline
Time frame: Baseline
Mean Hb Value at Month 3 After Inclusion
Time frame: Month 3
Mean Hb Value at Month 6 After Inclusion
Time frame: Month 6
Mean Hb Value at Month 9 After Inclusion
Time frame: Month 9
Mean Hb Value at Month 12 After Inclusion
Time frame: Month 12
Percentage of Participants With Hb Fluctuation From Pre-Baseline (Month -6) to Baseline
Time frame: Pre-baseline (Month -6) to Baseline
Hb fluctuation was defined as change in Hb value >15 gm/L between 2 visits.
Percentage of Participants With Hb Fluctuation From Baseline to Month 12
Time frame: Baseline to Month 12
Hb fluctuation was defined as change in Hb value >15 gm/L between 2 visits.

10 secondary outcomes

Percentage of Participants With Change in MIRCERA Treatment
Time frame: Months 3, 6, 9, and 12
Percentage of Participants With Number of MIRCERA Dose Changes
Time frame: Baseline to Month 12
Correlation of Hb Levels With Underlying Disease
Time frame: Baseline to 12 months
Correlation of Hb Levels With Levels of Inflammation
Time frame: Baseline to 12 months
Percentage of Participants With Changes in Iron Supplement
Time frame: Pre-baseline (Months -6 and -3), baseline, Months 3, 6, 9 and 12
Percentage of Participants With Changes in Immunosuppressive Treatment
Time frame: Pre-baseline (Months -6 and -3), baseline, Months 3, 6, 9 and 12
Percentage of Participants With Changes in Antihypertensive Treatment
Time frame: Pre-baseline (Months -6 and -3), baseline, Months 3, 6, 9 and 12
Number of Participants With Different Medication Treatment
Time frame: Pre-baseline (Month -6) to Month 12
Percentage of Participants Who Required Blood Transfusion
Time frame: Pre-baseline (Months -6 and -3), baseline, Months 3, 6, 9 and 12
Percentage of Participants Who Required Renal Replacement Therapy
Time frame: Months 3, 6, 9, and 12

Results and safety

Results posted to the registry on 30 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
Chronic Kidney Disease (CKD) Participants	144	109

Primary outcome: Percentage of Participants Reaching a Hemoglobin (Hb) Value of Greater Than (>) 100 and Less Than (<) 120 Grams Per Liter (gm/L) at Month 6 Before Inclusion

Time frame: Pre-baseline (Month -6). Number. Unit: percentage of participants

Measure	CKD Participants n = 125
Value	56.8

Population analysed: All enrolled participants. Here, number of participants analyzed= participants with non-missing Hb assessment at specified time frame for this outcome measure.

Primary outcome: Percentage of Participants Reaching a Hb Value of >100 and < 120 gm/L at Month 3 Before Inclusion

Time frame: Pre-baseline (Month -3). Number. Unit: percentage of participants

Measure	CKD Participants n = 116
Value	56.0

Population analysed: All enrolled participants. Here, number of participants analyzed= participants with non-missing Hb assessment at specified time frame for this outcome measure.

Primary outcome: Percentage of Participants Reaching a Hb Value of >100 and < 120 gm/L at Baseline

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

Measure	CKD Participants n = 139
Value	42.4

Population analysed: All enrolled participants. Here, number of participants analyzed= participants with non-missing Hb assessment at specified time frame for this outcome measure.

Primary outcome: Percentage of Participants Reaching a Hb Value of > 100 and < 120 gm/L at Month 3 After Inclusion

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

Measure	CKD Participants n = 122
Value	41.0

Population analysed: All enrolled participants. Here, number of participants analyzed= participants with non-missing Hb assessment at specified time frame for this outcome measure.

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: Pre-baseline (Month -6) to Month 12. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CKD Participants	0 of 141 (0%)	1 of 141 (0.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Anemia

RecruitingPhase 1/2
The Safety and Efficacy of Daratumumab in Patients With Refractory Aplastic Anemia
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Active, not recruitingPhase 1
A Study of YTS109 Cell Injection in Subjects With Relapsed/Refractory Autoimmune Hemolytic Anemia
Autoimmune Hemolytic Anemia, Anti-CD19 STAR T-cell Therapy
Not yet recruitingObservational study
Systematic Intraoperative Cell Salvage in On-Pump Cardiac Surgery Within a Mature Patient Blood Management Programme
Cardiac Surgical Procedures, Blood Transfusion
RecruitingPhase 1/2
Pacritinib, a Kinase Inhibitor of CSF1R, IRAK1, JAK2, and FLT3, in Adults and Pediatric Participants 12 Years of Age or Older With Myelodysplastic Syndromes or Myelodysplastic/Myeloproliferative Neoplasms
Myelodysplastic Syndromes
RecruitingObservational study
Defining the Natural History of Squamous Cell Carcinoma in Fanconi Anemia
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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

20 sites 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 20 sites in Sweden.

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 11 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in Sweden. 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 30 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 Reaching a Hemoglobin (Hb) Value of Greater Than (>) 100 and Less Than (<) 120 Grams Per Liter (gm/L) at Month 6 Before Inclusion (time frame: Pre-baseline (Month -6)). The study lists 16 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 NCT02567188.

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 11 Sep 2025.