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

Completed

• Conditions: Anemia
• Interventions: Other: MIRCERA

• Registration Number: NCT02567188
• Lead Sponsor: Hoffmann-La Roche

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Study First Submitted: 2015-09-28
• Study First Submitted QC: 2015-09-30
• Study First Posted: 2015-10-02
• Results First Submitted: 2015-11-02
• Results First Submitted QC: 2015-11-24
• Results First Posted: 2015-12-30
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-14
• Last Update Posted: 2016-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 144

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)

Read More

Exclusion Criteria

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort of CKD Participants	MIRCERA	Pre-dialysis participants with CKD treated with MIRCERA according to the current standard of care and in line with the current local summary of product characteristics were observed for maximum of 12 months.

Primary Outcome Measures

Name	Time	Method
Mean Hb Value at Month 3 Before Inclusion	Pre-baseline (Month -3)
Percentage of Participants Reaching a Hb Value of > 100 and < 120 gm/L at Month 3 After Inclusion	Month 3
Mean Hb Value at Month 6 Before Inclusion	Pre-baseline (Month -6)
Mean Hb Value at Month 3 After Inclusion	Month 3
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	Pre-baseline (Month -6)
Percentage of Participants Reaching a Hb Value of > 100 and < 120 gm/L at Month 6 After Inclusion	Month 6
Mean Hb Value at Month 6 After Inclusion	Month 6
Percentage of Participants With Hb Fluctuation From Pre-Baseline (Month -6) to Baseline	Pre-baseline (Month -6) to Baseline	Hb fluctuation was defined as change in Hb value \>15 gm/L between 2 visits.
Percentage of Participants With Hb Fluctuation From Baseline to Month 12	Baseline to Month 12	Hb fluctuation was defined as change in Hb value \>15 gm/L between 2 visits.
Percentage of Participants Reaching a Hb Value of > 100 and < 120 gm/L at Month 9 After Inclusion	Month 9
Percentage of Participants Reaching a Hb Value of > 100 and < 120 gm/L at Month 12 After Inclusion	Month 12
Mean Hb Value at Month 9 After Inclusion	Month 9
Mean Hb Value at Month 12 After Inclusion	Month 12
Percentage of Participants Reaching a Hb Value of >100 and < 120 gm/L at Month 3 Before Inclusion	Pre-baseline (Month -3)
Percentage of Participants Reaching a Hb Value of >100 and < 120 gm/L at Baseline	Baseline
Mean Hb Value at Baseline	Baseline

Secondary Outcome Measures

Name	Time	Method
Correlation of Hb Levels With Underlying Disease	Baseline to 12 months
Correlation of Hb Levels With Levels of Inflammation	Baseline to 12 months
Percentage of Participants Who Required Blood Transfusion	Pre-baseline (Months -6 and -3), baseline, Months 3, 6, 9 and 12
Percentage of Participants With Change in MIRCERA Treatment	Months 3, 6, 9, and 12	Change in MIRCERA treatment included changes in dose, frequency, and route of administration.
Percentage of Participants With Number of MIRCERA Dose Changes	Baseline to Month 12
Number of Participants With Different Medication Treatment	Pre-baseline (Month -6) to Month 12	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.
Percentage of Participants With Changes in Iron Supplement	Pre-baseline (Months -6 and -3), baseline, Months 3, 6, 9 and 12	Percentage of participants who had any change in their iron supplement medication at a specified visit were reported.
Percentage of Participants With Changes in Immunosuppressive Treatment	Pre-baseline (Months -6 and -3), baseline, Months 3, 6, 9 and 12	Percentage of participants who had any change in their immunosuppressive medication at a specified visit were reported.
Percentage of Participants With Changes in AntihypertensiveTreatment	Pre-baseline (Months -6 and -3), baseline, Months 3, 6, 9 and 12	Percentage of participants who had any change in their antihypertensive medication at a specified visit were reported.
Percentage of Participants Who Required Renal Replacement Therapy	Months 3, 6, 9, and 12	Renal replacement therapy was defined as hemodialysis and peritoneal dialysis.