A Study of MIRCERA in Participants With Chronic Kidney Disease Stage 3-4 and Not on Dialysis

Hoffmann-La Roche144 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

144

Conditions

Anemia

Interventions

MIRCERAOTHER

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (20)

Unnamed facility

Angeholm, Sweden

Unnamed facility

Bollnäs, Sweden

Unnamed facility

Eskilstuna, Sweden

Outcomes

Primary Outcomes

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

Time frame: Pre-baseline (Month -6)

Percentage of Participants Reaching a Hb Value of >100 and < 120 gm/L at Month 3 Before Inclusion

Time frame: Pre-baseline (Month -3)

Percentage of Participants Reaching a Hb Value of >100 and < 120 gm/L at Baseline

Time frame: Baseline

Percentage of Participants Reaching a Hb Value of > 100 and < 120 gm/L at Month 3 After Inclusion

Time frame: Month 3

Percentage of Participants Reaching a Hb Value of > 100 and < 120 gm/L at Month 6 After Inclusion

Time frame: Month 6

Percentage of Participants Reaching a Hb Value of > 100 and < 120 gm/L at Month 9 After Inclusion

Time frame: Month 9

Percentage of Participants Reaching a Hb Value of > 100 and < 120 gm/L at Month 12 After Inclusion

Time frame: Month 12

Mean Hb Value at Month 6 Before Inclusion

Time frame: Pre-baseline (Month -6)

Mean Hb Value at Month 3 Before Inclusion

Time frame: Pre-baseline (Month -3)

Mean Hb Value at Baseline

Time frame: Baseline

Mean Hb Value at Month 3 After Inclusion

Time frame: Month 3

Data from ClinicalTrials.gov

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Secondary Outcomes

Percentage of Participants With Change in MIRCERA Treatment

Change in MIRCERA treatment included changes in dose, frequency, and route of administration.

Time frame: Months 3, 6, 9, and 12

Percentage of Participants With Number of MIRCERA Dose Changes

Time frame: Baseline to Month 12

Correlation of Hb Levels With Underlying Disease

Time frame: Baseline to 12 months

Correlation of Hb Levels With Levels of Inflammation

Time frame: Baseline to 12 months

Percentage of Participants With Changes in Iron Supplement

Percentage of participants who had any change in their iron supplement medication at a specified visit were reported.

Time frame: Pre-baseline (Months -6 and -3), baseline, Months 3, 6, 9 and 12

Percentage of Participants With Changes in Immunosuppressive Treatment

Percentage of participants who had any change in their immunosuppressive medication at a specified visit were reported.

Time frame: Pre-baseline (Months -6 and -3), baseline, Months 3, 6, 9 and 12

Percentage of Participants With Changes in Antihypertensive Treatment

Percentage of participants who had any change in their antihypertensive medication at a specified visit were reported.

Time frame: Pre-baseline (Months -6 and -3), baseline, Months 3, 6, 9 and 12

Number of Participants With Different Medication Treatment

Number of participants who were receiving different treatments (antihypertensive, immunosuppressive, iron supplements, and others) before and/or after baseline were reported. Same participant could be reported in more than one category.

Time frame: Pre-baseline (Month -6) to Month 12

Percentage of Participants Who Required Blood Transfusion

Time frame: Pre-baseline (Months -6 and -3), baseline, Months 3, 6, 9 and 12

Percentage of Participants Who Required Renal Replacement Therapy

Renal replacement therapy was defined as hemodialysis and peritoneal dialysis.

Time frame: Months 3, 6, 9, and 12