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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02567188

Enrollment

144

Registered

2015-10-02

Start date

2009-04-30

Completion date

2011-04-30

Last updated

2025-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia

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.

Interventions

OTHERMIRCERA

Study design

Observational model

CASE_CONTROL

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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 6 Before Inclusion	Pre-baseline (Month -6)	—
Mean Hb Value at Month 3 Before Inclusion	Pre-baseline (Month -3)	—
Mean Hb Value at Baseline	Baseline	—
Mean Hb Value at Month 3 After Inclusion	Month 3	—
Mean Hb Value at Month 6 After Inclusion	Month 6	—
Mean Hb Value at Month 9 After Inclusion	Month 9	—
Mean Hb Value at Month 12 After Inclusion	Month 12	—
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 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 3 Before Inclusion	Pre-baseline (Month -3)	—
Percentage of Participants Reaching a Hb Value of >100 and < 120 gm/L at Baseline	Baseline	—
Percentage of Participants Reaching a Hb Value of > 100 and < 120 gm/L at Month 3 After Inclusion	Month 3	—
Percentage of Participants Reaching a Hb Value of > 100 and < 120 gm/L at Month 6 After Inclusion	Month 6	—

Secondary

Measure	Time frame	Description
Percentage of Participants Who Required Renal Replacement Therapy	Months 3, 6, 9, and 12	Renal replacement therapy was defined as hemodialysis and peritoneal dialysis.
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	—
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 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 Antihypertensive Treatment	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.
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 Who Required Blood Transfusion	Pre-baseline (Months -6 and -3), baseline, Months 3, 6, 9 and 12	—

Countries

Sweden

Participant flow

Participants by arm

Arm	Count
CKD Participants 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.	141
Total	141

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Adverse Event	1
Overall Study	Death	10
Overall Study	Lost to Follow-up	5
Overall Study	Moved and Changed Clinic	1
Overall Study	Protocol Violation	5
Overall Study	Refused Treatment/ Did not Cooperate	1
Overall Study	Started Hemodialysis	2
Overall Study	Terminated Mircera Treatment	9
Overall Study	Withdrawal by Subject	1

Baseline characteristics

Characteristic	CKD Participants
Age, Continuous	66.2 years STANDARD_DEVIATION 16.5
Sex: Female, Male Female	64 Participants
Sex: Female, Male Male	77 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	1 / 141
serious Total, serious adverse events	0 / 141