An Observational Study to Evaluate the Effectiveness of Mircera Treatment for Renal Anemia in Pre-dialysis Participants With Chronic Kideny Disease (CKD)
- Conditions
- Kidney Disease, Chronic
- Interventions
- Registration Number
- NCT02547454
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 393
- Participants aged > 18 years with CKD
- Participants who are eligible for Mircera treatment according to current guidelines and summary of product characteristics (SmPC)
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description CKD participants treated with Mircera Methoxy polyethylene glycol-epoetin beta Participants with CKD received Mircera, as per routine clinical practice and was followed for approximately 36 months.
- Primary Outcome Measures
Name Time Method Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 7-9 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.
Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 13-15 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.
Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 16-18 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.
Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 1-3 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.
Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 10-12 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.
Percentage of Participants With Hemoglobin (Hb) Value Within the Target Range (110 to 120 Grams Per Liter [g/L]) at Baseline Baseline If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.
Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 1-3 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.
Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 10-12 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.
Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 13-15 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.
Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 4-6 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.
Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 19-21 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.
Percentage of Participants With Hemoglobin (Hb) Value Within the Target Range (100 to 130 g/L) at Baseline At Baseline If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.
Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) After 21 Months up to 36 Months 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.
Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 4-6 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.
Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 7-9 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.
Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 19-21 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.
Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) After 21 Months up to 36 Months 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.
Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 16-18 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.
- Secondary Outcome Measures
Name Time Method Percentage of Participants With Iron Replacement Up to 36 Months Iron replacement was given to the participants either in oral iron replacement or intravenous replacement or both.
Median Time in Which Hb Value Was Maintained Within Target Range of 110-120 g/L Up to 36 Months Average Dose of Methoxy Polyethylene Glycol-Epoetin Beta Baseline Average dose of methoxy polyethylene glycol-epoetin beta administered at Baseline
Number of Dose Adaptations 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).
Median Time in Which Hb Value Was Maintained Within Target Range of 100-130 g/L Up to 36 Months Median Dose of Methoxy Polyethylene Glycol-Epoetin Beta 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.
Percentage of Participants With Dose 0 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.
Trial Locations
- Locations (12)
Hospital Celje; Dept For Kidney Disease & Dialysis
๐ธ๐ฎCelje, Slovenia
Splosna Bolnisnica Izola; Oddelek Za Nefrologijo
๐ธ๐ฎIzola, Slovenia
Clinical Centre Ljubljana; Clinical Dep. For Nephrology
๐ธ๐ฎLjubljana, Slovenia
Nefroloska Ambulanta
๐ธ๐ฎLjubljana, Slovenia
Hospital Maribor; Clinical Dept For Internal Medicine
๐ธ๐ฎMaribor, Slovenia
Splosna Bolnisnica Murska Sobota; Oddelek Za Nefrologijo
๐ธ๐ฎMurska Sobota, Slovenia
Zdravstveni Zavod Medicinski Center ล inigoj Nova Gorica
๐ธ๐ฎNova Gorica, Slovenia
Hospital Dr.Joze Potre; Dialysis Dept
๐ธ๐ฎPtuj, Slovenia
Hospital Novo Mesto; Dialysis Dept
๐ธ๐ฎNovo Mesto, Slovenia
Splosna Bolnisnica Franc Derganc; Oddelek Za Nefrologijo
๐ธ๐ฎSempeter Pri Novi Gorici, Slovenia
Hospital Slovenj Gradec; Hemodialysis Dept
๐ธ๐ฎSlovenj Gradec, Slovenia
Splosna Bolnisnica Trbovlje; Oddelek Za Nefrologijo
๐ธ๐ฎTrbovlje, Slovenia