Clinical trial NCT02547454: An Observational Study to Evaluate the Effectiveness of Mircera Treatment for Renal Anemia in Pre-dialysis Participants With Chronic Kideny Disease (CKD)
Official title: Investigating the Effectiveness of Renal Anaemia Treatment in Pre-Dialysis Patients With Mircera in Daily Clinical Practice - MIRVITA
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kidney Disease, Chronic
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2015-09-11
Enrollment: 393
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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

Primary outcomes:
measure: Percentage of Participants With Hemoglobin (Hb) Value Within the Target Range (110 to 120 Grams Per Liter [g/L]) at Baseline
timeFrame: Baseline
measure: Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 1-3
timeFrame: At Months 1-3
measure: Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 4-6
timeFrame: At Months 4-6
measure: Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 7-9
timeFrame: At Months 7-9
measure: Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 10-12
timeFrame: At Months 10-12
measure: Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 13-15
timeFrame: At Months 13-15
measure: Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 16-18
timeFrame: At Months 16-18
measure: Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 19-21
timeFrame: At Months 19-21
measure: Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) After 21 Months up to 36 Months
timeFrame: After 21 Months up to 36 Months
measure: Percentage of Participants With Hemoglobin (Hb) Value Within the Target Range (100 to 130 g/L) at Baseline
timeFrame: At Baseline
measure: Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 1-3
timeFrame: At Months 1-3
measure: Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 4-6
timeFrame: At Months 4-6
measure: Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 7-9
timeFrame: At Months 7-9
measure: Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 10-12
timeFrame: At Months 10-12
measure: Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 13-15
timeFrame: At Months 13-15
measure: Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 16-18
timeFrame: At Months 16-18
measure: Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 19-21
timeFrame: At Months 19-21
measure: Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) After 21 Months up to 36 Months
timeFrame: After 21 Months up to 36 Months
Secondary outcomes:
measure: Median Time in Which Hb Value Was Maintained Within Target Range of 110-120 g/L
timeFrame: Up to 36 Months
measure: Median Time in Which Hb Value Was Maintained Within Target Range of 100-130 g/L
timeFrame: Up to 36 Months
measure: Average Dose of Methoxy Polyethylene Glycol-Epoetin Beta
timeFrame: Baseline
measure: Median Dose of Methoxy Polyethylene Glycol-Epoetin Beta
timeFrame: Month 1, Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, Month 21 and After 21 Months up to 36 Months
measure: Number of Dose Adaptations
timeFrame: Up to 36 Months
measure: Percentage of Participants With Dose 0
timeFrame: Up to 36 Months
measure: Percentage of Participants With Iron Replacement
timeFrame: Up to 36 Months
Other outcomes:
Locations:
city: Celje
country: Slovenia
facility: Hospital Celje; Dept For Kidney Disease & Dialysis
city: Izola
country: Slovenia
facility: Splosna Bolnisnica Izola; Oddelek Za Nefrologijo
city: Ljubljana
country: Slovenia
facility: Clinical Centre Ljubljana; Clinical Dep. For Nephrology
city: Ljubljana
country: Slovenia
facility: Nefroloska Ambulanta
city: Maribor
country: Slovenia
facility: Hospital Maribor; Clinical Dept For Internal Medicine
city: Murska Sobota
country: Slovenia
facility: Splosna Bolnisnica Murska Sobota; Oddelek Za Nefrologijo
city: Nova Gorica
country: Slovenia
facility: Zdravstveni Zavod Medicinski Center Šinigoj Nova Gorica
city: Novo Mesto
country: Slovenia
facility: Hospital Novo Mesto; Dialysis Dept
city: Ptuj
country: Slovenia
facility: Hospital Dr.Joze Potre; Dialysis Dept
city: Sempeter Pri Novi Gorici
country: Slovenia
facility: Splosna Bolnisnica Franc Derganc; Oddelek Za Nefrologijo
city: Slovenj Gradec
country: Slovenia
facility: Hospital Slovenj Gradec; Hemodialysis Dept
city: Trbovlje
country: Slovenia
facility: Splosna Bolnisnica Trbovlje; Oddelek Za Nefrologijo
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: