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Completed

NCT Number: NCT02567188

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

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.

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Key information

Conditions

Anemia Hematologic Diseases Hemic and Lymphatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Angeholm, Sweden

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MIRCERA

Other

Primary outcomes

  1. 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)

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

    Time frame: Pre-baseline (Month -3)

  3. Percentage of Participants Reaching a Hb Value of >100 and < 120 gm/L at Baseline

    Time frame: Baseline

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

    Time frame: Month 3

  5. Percentage of Participants Reaching a Hb Value of > 100 and < 120 gm/L at Month 6 After Inclusion

    Time frame: Month 6

  6. Percentage of Participants Reaching a Hb Value of > 100 and < 120 gm/L at Month 9 After Inclusion

    Time frame: Month 9

  7. Percentage of Participants Reaching a Hb Value of > 100 and < 120 gm/L at Month 12 After Inclusion

    Time frame: Month 12

  8. Mean Hb Value at Month 6 Before Inclusion

    Time frame: Pre-baseline (Month -6)

  9. Mean Hb Value at Month 3 Before Inclusion

    Time frame: Pre-baseline (Month -3)

  10. Mean Hb Value at Baseline

    Time frame: Baseline

  11. Mean Hb Value at Month 3 After Inclusion

    Time frame: Month 3

  12. Mean Hb Value at Month 6 After Inclusion

    Time frame: Month 6

  13. Mean Hb Value at Month 9 After Inclusion

    Time frame: Month 9

  14. Mean Hb Value at Month 12 After Inclusion

    Time frame: Month 12

  15. 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.

  16. 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.

Secondary outcomes

  1. 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.

  2. Percentage of Participants With Number of MIRCERA Dose Changes

    Time frame: Baseline to Month 12

  3. Correlation of Hb Levels With Underlying Disease

    Time frame: Baseline to 12 months

  4. Correlation of Hb Levels With Levels of Inflammation

    Time frame: Baseline to 12 months

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. Percentage of Participants Who Required Blood Transfusion

    Time frame: Pre-baseline (Months -6 and -3), baseline, Months 3, 6, 9 and 12

  10. 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.

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Oct 2, 2015
Registry last updated
Sep 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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