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

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ClinicalTrials.gov Identifier: NCT02547454
Recruitment Status : Completed
First Posted : September 11, 2015
Results First Posted : November 23, 2015
Last Update Posted : June 7, 2017
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
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.

Condition or disease Intervention/treatment
Kidney Disease, Chronic Drug: Methoxy polyethylene glycol-epoetin beta

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Study Type : Observational
Actual Enrollment : 393 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Investigating the Effectiveness of Renal Anaemia Treatment in Pre-Dialysis Patients With Mircera in Daily Clinical Practice - MIRVITA
Actual Study Start Date : December 31, 2008
Actual Primary Completion Date : November 30, 2014
Actual Study Completion Date : November 30, 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia

Group/Cohort Intervention/treatment
CKD participants treated with Mircera
Participants with CKD received Mircera, as per routine clinical practice and was followed for approximately 36 months.
Drug: Methoxy polyethylene glycol-epoetin beta
Other Name: Mircera




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants with CKD who do not require dialysis and are appropriate for treatment with Mircera according to European Best Practice Guidelines (EBPG) and Kidney Disease Outcomes Quality Initiative (K/DOQI) guidelines.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02547454


Locations
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Slovenia
Hospital Celje; Dept For Kidney Disease & Dialysis
Celje, Slovenia, 3000
Splosna Bolnisnica Izola; Oddelek Za Nefrologijo
Izola, Slovenia, 6310
Clinical Centre Ljubljana; Clinical Dep. For Nephrology
Ljubljana, Slovenia, 1000
Nefroloska Ambulanta
Ljubljana, Slovenia, 1000
Hospital Maribor; Clinical Dept For Internal Medicine
Maribor, Slovenia, 2000
Splosna Bolnisnica Murska Sobota; Oddelek Za Nefrologijo
Murska Sobota, Slovenia, 9000
Zdravstveni Zavod Medicinski Center Šinigoj Nova Gorica
Nova Gorica, Slovenia, 5000
Hospital Novo Mesto; Dialysis Dept
Novo Mesto, Slovenia, 8000
Hospital Dr.Joze Potre; Dialysis Dept
Ptuj, Slovenia, 2250
Splosna Bolnisnica Franc Derganc; Oddelek Za Nefrologijo
Sempeter Pri Novi Gorici, Slovenia, 5390
Hospital Slovenj Gradec; Hemodialysis Dept
Slovenj Gradec, Slovenia, 2380
Splosna Bolnisnica Trbovlje; Oddelek Za Nefrologijo
Trbovlje, Slovenia, 1420
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche

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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02547454     History of Changes
Other Study ID Numbers: ML22069
First Posted: September 11, 2015    Key Record Dates
Results First Posted: November 23, 2015
Last Update Posted: June 7, 2017
Last Verified: May 2017

Additional relevant MeSH terms:
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Kidney Diseases
Chronic Disease
Renal Insufficiency, Chronic
Urologic Diseases
Disease Attributes
Pathologic Processes
Renal Insufficiency