Clinical trial NCT02567188: A Study of MIRCERA in Participants With Chronic Kidney Disease Stage 3-4 and Not on Dialysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anemia
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2015-10-02
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult participants with CKD Stage 3-4 treated with MIRCERA

Brief summary: An observational, longitudinal, multi-center, non-interventional study in participants with chronic kidney disease (CKD) stage 3-4, assessed by Modification of Diet in Renal Disease (MDRD) to collect data regarding safety and efficacy in participants with pre-dialysis situation who are treated with MIRCERA in normal clinical environment.


Eligibility criteria: Inclusion Criteria:

* Adult participants above 18 years of age
* Pre-dialysis participants with CKD stage 3-4 treated with MIRCERA and continue in the pre-dialysis state for the whole study period
* Estimated glomerular filteration rate (e-GFR) between 15-60 milliliter per minute (mL/min) (calculated)

Exclusion Criteria:

* Participants involved in interventional trials
* Participants with life expectancy less than 1 year
* Active malignancy
* Planned living kidney transplant within 6 months.

Primary outcomes:
measure: Percentage of Participants Reaching a Hemoglobin (Hb) Value of Greater Than (>) 100 and Less Than (<) 120 Grams Per Liter (gm/L) at Month 6 Before Inclusion
timeFrame: Pre-baseline (Month -6)
measure: Percentage of Participants Reaching a Hb Value of >100 and < 120 gm/L at Month 3 Before Inclusion
timeFrame: Pre-baseline (Month -3)
measure: Percentage of Participants Reaching a Hb Value of >100 and < 120 gm/L at Baseline
timeFrame: Baseline
measure: Percentage of Participants Reaching a Hb Value of > 100 and < 120 gm/L at Month 3 After Inclusion
timeFrame: Month 3
measure: Percentage of Participants Reaching a Hb Value of > 100 and < 120 gm/L at Month 6 After Inclusion
timeFrame: Month 6
measure: Percentage of Participants Reaching a Hb Value of > 100 and < 120 gm/L at Month 9 After Inclusion
timeFrame: Month 9
measure: Percentage of Participants Reaching a Hb Value of > 100 and < 120 gm/L at Month 12 After Inclusion
timeFrame: Month 12
measure: Mean Hb Value at Month 6 Before Inclusion
timeFrame: Pre-baseline (Month -6)
measure: Mean Hb Value at Month 3 Before Inclusion
timeFrame: Pre-baseline (Month -3)
measure: Mean Hb Value at Baseline
timeFrame: Baseline
measure: Mean Hb Value at Month 3 After Inclusion
timeFrame: Month 3
measure: Mean Hb Value at Month 6 After Inclusion
timeFrame: Month 6
measure: Mean Hb Value at Month 9 After Inclusion
timeFrame: Month 9
measure: Mean Hb Value at Month 12 After Inclusion
timeFrame: Month 12
measure: Percentage of Participants With Hb Fluctuation From Pre-Baseline (Month -6) to Baseline
timeFrame: Pre-baseline (Month -6) to Baseline
measure: Percentage of Participants With Hb Fluctuation From Baseline to Month 12
timeFrame: Baseline to Month 12
Secondary outcomes:
measure: Percentage of Participants With Change in MIRCERA Treatment
timeFrame: Months 3, 6, 9, and 12
measure: Percentage of Participants With Number of MIRCERA Dose Changes
timeFrame: Baseline to Month 12
measure: Correlation of Hb Levels With Underlying Disease
timeFrame: Baseline to 12 months
measure: Correlation of Hb Levels With Levels of Inflammation
timeFrame: Baseline to 12 months
measure: Percentage of Participants With Changes in Iron Supplement
timeFrame: Pre-baseline (Months -6 and -3), baseline, Months 3, 6, 9 and 12
measure: Percentage of Participants With Changes in Immunosuppressive Treatment
timeFrame: Pre-baseline (Months -6 and -3), baseline, Months 3, 6, 9 and 12
measure: Percentage of Participants With Changes in AntihypertensiveTreatment
timeFrame: Pre-baseline (Months -6 and -3), baseline, Months 3, 6, 9 and 12
measure: Number of Participants With Different Medication Treatment
timeFrame: Pre-baseline (Month -6) to Month 12
measure: Percentage of Participants Who Required Blood Transfusion
timeFrame: Pre-baseline (Months -6 and -3), baseline, Months 3, 6, 9 and 12
measure: Percentage of Participants Who Required Renal Replacement Therapy
timeFrame: Months 3, 6, 9, and 12
Other outcomes:
Locations:
city: Angeholm
country: Sweden
city: Bollnas
country: Sweden
city: Eskilstuna
country: Sweden
city: Gaevle
country: Sweden
city: Goeteborg
country: Sweden
city: Gothenburg
country: Sweden
city: Huddinge
country: Sweden
city: Jonkoping
country: Sweden
city: Karlshamn
country: Sweden
city: Karlstad
country: Sweden
city: Kristianstad
country: Sweden
city: Linkoeping
country: Sweden
city: Mölndal
country: Sweden
city: Norrkoeping
country: Sweden
city: Skövde
country: Sweden
city: Stockholm
country: Sweden
city: Stockholm
country: Sweden
city: Umea
country: Sweden
city: Värnamo
country: Sweden
city: Västervik
country: Sweden
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: