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

Hoffmann-La Roche393 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

393

Conditions

Kidney Disease, Chronic

Interventions

Methoxy polyethylene glycol-epoetin betaDRUG

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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

Locations (12)

Hospital Celje; Dept For Kidney Disease & Dialysis

Celje, Slovenia

Splosna Bolnisnica Izola; Oddelek Za Nefrologijo

Izola, Slovenia

Clinical Centre Ljubljana; Clinical Dep. For Nephrology

Ljubljana, Slovenia

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: At Months 13-15

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Nefroloska Ambulanta

Ljubljana, Slovenia

Hospital Maribor; Clinical Dept For Internal Medicine

Maribor, Slovenia

Splosna Bolnisnica Murska Sobota; Oddelek Za Nefrologijo

Murska Sobota, Slovenia

Zdravstveni Zavod Medicinski Center Šinigoj Nova Gorica

Nova Gorica, Slovenia

Hospital Novo Mesto; Dialysis Dept

Novo Mesto, Slovenia

Hospital Dr.Joze Potre; Dialysis Dept

Ptuj, Slovenia

Splosna Bolnisnica Franc Derganc; Oddelek Za Nefrologijo

Sempeter Pri Novi Gorici, Slovenia

...and 2 more locations

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: After 21 Months up to 36 Months

Secondary Outcomes

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

Time frame: Up to 36 Months

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

Time frame: Up to 36 Months

Average Dose of Methoxy Polyethylene Glycol-Epoetin Beta

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

Time frame: 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.

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

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).

Time frame: 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.

Time frame: 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.

Time frame: Up to 36 Months