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

August 22, 2025 updated by: Hoffmann-La Roche
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 clinical environment.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
144

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult participants with CKD Stage 3-4 treated with MIRCERA

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: MIRCERA

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
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)
Pre-baseline (Month -3)
Percentage of Participants Reaching a Hb Value of >100 and < 120 gm/L at Baseline
Time Frame: Baseline
Baseline
Percentage of Participants Reaching a Hb Value of > 100 and < 120 gm/L at Month 3 After Inclusion
Time Frame: Month 3
Month 3
Percentage of Participants Reaching a Hb Value of > 100 and < 120 gm/L at Month 6 After Inclusion
Time Frame: Month 6
Month 6
Percentage of Participants Reaching a Hb Value of > 100 and < 120 gm/L at Month 9 After Inclusion
Time Frame: Month 9
Month 9
Percentage of Participants Reaching a Hb Value of > 100 and < 120 gm/L at Month 12 After Inclusion
Time Frame: Month 12
Month 12
Mean Hb Value at Month 6 Before Inclusion
Time Frame: Pre-baseline (Month -6)
Pre-baseline (Month -6)
Mean Hb Value at Month 3 Before Inclusion
Time Frame: Pre-baseline (Month -3)
Pre-baseline (Month -3)
Mean Hb Value at Baseline
Time Frame: Baseline
Baseline
Mean Hb Value at Month 3 After Inclusion
Time Frame: Month 3
Month 3
Mean Hb Value at Month 6 After Inclusion
Time Frame: Month 6
Month 6
Mean Hb Value at Month 9 After Inclusion
Time Frame: Month 9
Month 9
Mean Hb Value at Month 12 After Inclusion
Time Frame: Month 12
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.
Pre-baseline (Month -6) to Baseline
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.
Baseline to Month 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Change in MIRCERA Treatment
Time Frame: Months 3, 6, 9, and 12
Change in MIRCERA treatment included changes in dose, frequency, and route of administration.
Months 3, 6, 9, and 12
Percentage of Participants With Number of MIRCERA Dose Changes
Time Frame: Baseline to Month 12
Baseline to Month 12
Correlation of Hb Levels With Underlying Disease
Time Frame: Baseline to 12 months
Baseline to 12 months
Correlation of Hb Levels With Levels of Inflammation
Time Frame: Baseline to 12 months
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 who had any change in their iron supplement medication at a specified visit were reported.
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 who had any change in their immunosuppressive medication at a specified visit were reported.
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
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.
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
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
Renal replacement therapy was defined as hemodialysis and peritoneal dialysis.
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
Percentage of participants who had any change in their antihypertensive medication at a specified visit were reported.
Pre-baseline (Months -6 and -3), baseline, Months 3, 6, 9 and 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hoffmann-La Roche

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Clinical Trials, Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 28, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 30, 2015

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 2, 2015

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 11, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 22, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ML22439

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings