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

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

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.

Study Overview

• Status: Completed
• Conditions: Kidney Disease, Chronic
• Intervention / Treatment: Drug: Methoxy polyethylene glycol-epoetin beta

• Study Type: Observational
• Enrollment (Actual): 393

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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 Names: Mircera

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Hemoglobin (Hb) Value Within the Target Range (110 to 120 Grams Per Liter [g/L]) at Baseline	If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.	Baseline
Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) 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.	At Months 1-3
Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) 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.	At Months 4-6
Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) 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.	At Months 7-9
Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) 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.	At Months 10-12
Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) 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.	At Months 13-15
Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) 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.	At Months 16-18
Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) 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.	At Months 19-21
Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) 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.	After 21 Months up to 36 Months
Percentage of Participants With Hemoglobin (Hb) Value Within the Target Range (100 to 130 g/L) at Baseline	If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.	At Baseline
Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) 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.	At Months 1-3
Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) 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.	At Months 4-6
Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) 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.	At Months 7-9
Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) 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.	At Months 10-12
Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) 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.	At Months 13-15
Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) 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.	At Months 16-18
Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) 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.	At Months 19-21
Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) 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.	After 21 Months up to 36 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Median Time in Which Hb Value Was Maintained Within Target Range of 110-120 g/L		Up to 36 Months
Median Time in Which Hb Value Was Maintained Within Target Range of 100-130 g/L		Up to 36 Months
Average Dose of Methoxy Polyethylene Glycol-Epoetin Beta	Average dose of methoxy polyethylene glycol-epoetin beta administered at Baseline	Baseline
Median Dose of Methoxy Polyethylene Glycol-Epoetin Beta	Median monthly dose of methoxy polyethylene glycol-epoetin beta administered in the study up to 36 months.	Month 1, Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, Month 21 and After 21 Months up to 36 Months
Number of Dose Adaptations	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).	Up to 36 Months
Percentage of Participants With Dose 0	Percentage of participants who did not use methoxy polyethylene glycol-epoetin beta (Dose 0) at atleast one visit during study period.	Up to 36 Months
Percentage of Participants With Iron Replacement	Iron replacement was given to the participants either in oral iron replacement or intravenous replacement or both.	Up to 36 Months

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start (Actual): December 31, 2008
• Primary Completion (Actual): November 30, 2014
• Study Completion (Actual): November 30, 2014

Study Registration Dates

• First Submitted: September 9, 2015
• First Submitted That Met QC Criteria: September 9, 2015
• First Posted (Estimate): September 11, 2015

Study Record Updates

• Last Update Posted (Actual): June 7, 2017
• Last Update Submitted That Met QC Criteria: May 9, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic; Hematinics; Epoetin Alfa
• Other Study ID Numbers: ML22069