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Completed

NCT Number: NCT02547454

An Observational Study to Evaluate the Effectiveness of Mircera Treatment for Renal Anemia in Pre-dialysis Participants With Chronic Kideny Disease (CKD)

This observational trial will examine the efficacy and safety of Mircera for renal anemia in participants with stage III-IV CKD in daily clinical practice. Mircera will be prescribed by treating physician and followed for approximately 36 months.

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Key information

Conditions

Kidney Disease, Chronic Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Celje; Dept For Kidney Disease & Dialysis, Celje, Slovenia

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Participants aged > 18 years with CKD
  • Participants who are eligible for Mircera treatment according to current guidelines and summary of product characteristics (SmPC)

Exclusion criteria

  • Non-renal anemia
  • Pregnancy and breast-feeding
  • Uncontrolled hypertension
  • Known hypersensitivity to methoxy polyethylene glycol-epoetin beta
  • Administration of any other study drug within 30 days prior to study enrollment

Treatment and study plan

methoxy polyethylene glycol-epoetin beta

Drug

Other names: Mircera

Primary outcomes

  1. Percentage of Participants With Hemoglobin (Hb) Value Within the Target Range (110 to 120 Grams Per Liter [g/L]) at Baseline

    Time frame: Baseline

    If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.

  2. Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 1-3

    Time frame: At Months 1-3

    If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.

  3. Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 4-6

    Time frame: At Months 4-6

    If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.

  4. Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 7-9

    Time frame: At Months 7-9

    If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.

  5. Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 10-12

    Time frame: At Months 10-12

    If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.

  6. Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 13-15

    Time frame: At Months 13-15

    If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.

  7. Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 16-18

    Time frame: At Months 16-18

    If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.

  8. Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 19-21

    Time frame: At Months 19-21

    If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.

  9. Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) After 21 Months up to 36 Months

    Time frame: After 21 Months up to 36 Months

    If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.

  10. Percentage of Participants With Hemoglobin (Hb) Value Within the Target Range (100 to 130 g/L) at Baseline

    Time frame: At Baseline

    If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.

  11. Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 1-3

    Time frame: At Months 1-3

    If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.

  12. Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 4-6

    Time frame: At Months 4-6

    If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.

  13. Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 7-9

    Time frame: At Months 7-9

    If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.

  14. Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 10-12

    Time frame: At Months 10-12

    If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.

  15. Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 13-15

    Time frame: At Months 13-15

    If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.

  16. Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 16-18

    Time frame: At Months 16-18

    If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.

  17. Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 19-21

    Time frame: At Months 19-21

    If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.

  18. Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) After 21 Months up to 36 Months

    Time frame: After 21 Months up to 36 Months

    If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.

Secondary outcomes

  1. Median Time in Which Hb Value Was Maintained Within Target Range of 110-120 g/L

    Time frame: Up to 36 Months

  2. Median Time in Which Hb Value Was Maintained Within Target Range of 100-130 g/L

    Time frame: Up to 36 Months

  3. Average Dose of Methoxy Polyethylene Glycol-Epoetin Beta

    Time frame: Baseline

    Average dose of methoxy polyethylene glycol-epoetin beta administered at Baseline

  4. Median Dose of Methoxy Polyethylene Glycol-Epoetin Beta

    Time frame: Month 1, Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, Month 21 and After 21 Months up to 36 Months

    Median monthly dose of methoxy polyethylene glycol-epoetin beta administered in the study up to 36 months.

  5. Number of Dose Adaptations

    Time frame: Up to 36 Months

    Total number of changes (increase or decrease) in daily methoxy polyethylene glycol-epoetin beta doses. The reasons for dose-adaptations included: inflammation or infection; kidney function decline; over-response; iron deficiency; insufficient response; adverse effect; start of maintenance dose; kidney function improvement; re-introduction of treatment; and others (other reasons than specified).

  6. Percentage of Participants With Dose 0

    Time frame: Up to 36 Months

    Percentage of participants who did not use methoxy polyethylene glycol-epoetin beta (Dose 0) at atleast one visit during study period.

  7. Percentage of Participants With Iron Replacement

    Time frame: Up to 36 Months

    Iron replacement was given to the participants either in oral iron replacement or intravenous replacement or both.

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

Investigating the Effectiveness of Renal Anaemia Treatment in Pre-Dialysis Patients With Mircera in Daily Clinical Practice - MIRVITA

Important dates

Study start
2008
Primary completion
2014
Study completion
2014
First posted
Sep 11, 2015
Registry last updated
Jun 7, 2017

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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