Trial Outcomes & Findings for A Study of MIRCERA in Participants With Chronic Kidney Disease Stage 3-4 and Not on Dialysis (NCT NCT02567188)
NCT ID: NCT02567188
Last Updated: 2025-09-11
Results Overview
COMPLETED
144 participants
Pre-baseline (Month -6)
2025-09-11
Participant Flow
Participant milestones
| Measure |
Chronic Kidney Disease (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.
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|---|---|
|
Overall Study
STARTED
|
144
|
|
Overall Study
COMPLETED
|
109
|
|
Overall Study
NOT COMPLETED
|
35
|
Reasons for withdrawal
| Measure |
Chronic Kidney Disease (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.
|
|---|---|
|
Overall Study
Death
|
10
|
|
Overall Study
Terminated Mircera Treatment
|
9
|
|
Overall Study
Lost to Follow-up
|
5
|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Refused Treatment/ Did not Cooperate
|
1
|
|
Overall Study
Moved and Changed Clinic
|
1
|
|
Overall Study
Started Hemodialysis
|
2
|
|
Overall Study
Protocol Violation
|
5
|
Baseline Characteristics
A Study of MIRCERA in Participants With Chronic Kidney Disease Stage 3-4 and Not on Dialysis
Baseline characteristics by cohort
| Measure |
CKD Participants
n=141 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.
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|---|---|
|
Age, Continuous
|
66.2 years
STANDARD_DEVIATION 16.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
64 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
77 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Pre-baseline (Month -6)Population: All enrolled participants. Here, number of participants analyzed= participants with non-missing Hb assessment at specified time frame for this outcome measure.
Outcome measures
| Measure |
CKD Participants
n=125 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.
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|---|---|
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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
|
56.8 percentage of participants
|
PRIMARY outcome
Timeframe: Pre-baseline (Month -3)Population: All enrolled participants. Here, number of participants analyzed= participants with non-missing Hb assessment at specified time frame for this outcome measure.
Outcome measures
| Measure |
CKD Participants
n=116 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.
|
|---|---|
|
Percentage of Participants Reaching a Hb Value of >100 and < 120 gm/L at Month 3 Before Inclusion
|
56.0 percentage of participants
|
PRIMARY outcome
Timeframe: BaselinePopulation: All enrolled participants. Here, number of participants analyzed= participants with non-missing Hb assessment at specified time frame for this outcome measure.
Outcome measures
| Measure |
CKD Participants
n=139 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.
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|---|---|
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Percentage of Participants Reaching a Hb Value of >100 and < 120 gm/L at Baseline
|
42.4 percentage of participants
|
PRIMARY outcome
Timeframe: Month 3Population: All enrolled participants. Here, number of participants analyzed= participants with non-missing Hb assessment at specified time frame for this outcome measure.
Outcome measures
| Measure |
CKD Participants
n=122 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.
|
|---|---|
|
Percentage of Participants Reaching a Hb Value of > 100 and < 120 gm/L at Month 3 After Inclusion
|
41.0 percentage of participants
|
PRIMARY outcome
Timeframe: Month 6Population: All enrolled participants. Here, number of participants analyzed= participants with non-missing Hb assessment at specified time frame for this outcome measure.
Outcome measures
| Measure |
CKD Participants
n=113 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.
|
|---|---|
|
Percentage of Participants Reaching a Hb Value of > 100 and < 120 gm/L at Month 6 After Inclusion
|
41.6 percentage of participants
|
PRIMARY outcome
Timeframe: Month 9Population: All enrolled participants. Here, number of participants analyzed= participants with non-missing Hb assessment at specified time frame for this outcome measure.
Outcome measures
| Measure |
CKD Participants
n=106 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.
|
|---|---|
|
Percentage of Participants Reaching a Hb Value of > 100 and < 120 gm/L at Month 9 After Inclusion
|
33.0 percentage of participants
|
PRIMARY outcome
Timeframe: Month 12Population: All enrolled participants. Here, number of participants analyzed= participants with non-missing Hb assessment at specified time frame for this outcome measure.
Outcome measures
| Measure |
CKD Participants
n=110 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.
|
|---|---|
|
Percentage of Participants Reaching a Hb Value of > 100 and < 120 gm/L at Month 12 After Inclusion
|
45.5 percentage of participants
|
PRIMARY outcome
Timeframe: Pre-baseline (Month -6)Population: All enrolled participants. Here, number of participants analyzed= participants with non-missing Hb assessment at specified time frame for this outcome measure.
Outcome measures
| Measure |
CKD Participants
n=125 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.
|
|---|---|
|
Mean Hb Value at Month 6 Before Inclusion
|
113.2 gm/L
Standard Deviation 11.7
|
PRIMARY outcome
Timeframe: Pre-baseline (Month -3)Population: All enrolled participants. Here, number of participants analyzed= participants with non-missing Hb assessment at specified time frame for this outcome measure.
Outcome measures
| Measure |
CKD Participants
n=116 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.
|
|---|---|
|
Mean Hb Value at Month 3 Before Inclusion
|
112.6 gm/L
Standard Deviation 13.2
|
PRIMARY outcome
Timeframe: BaselinePopulation: All enrolled participants. Here, number of participants analyzed= participants with non-missing Hb assessment at specified time frame for this outcome measure.
Outcome measures
| Measure |
CKD Participants
n=139 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.
|
|---|---|
|
Mean Hb Value at Baseline
|
117.5 gm/L
Standard Deviation 15.0
|
PRIMARY outcome
Timeframe: Month 3Population: All enrolled participants. Here, number of participants analyzed= participants with non-missing Hb assessment at specified time frame for this outcome measure.
Outcome measures
| Measure |
CKD Participants
n=122 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.
|
|---|---|
|
Mean Hb Value at Month 3 After Inclusion
|
120.2 gm/L
Standard Deviation 13.2
|
PRIMARY outcome
Timeframe: Month 6Population: All enrolled participants. Here, number of participants analyzed= participants with non-missing Hb assessment at specified time frame for this outcome measure.
Outcome measures
| Measure |
CKD Participants
n=113 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.
|
|---|---|
|
Mean Hb Value at Month 6 After Inclusion
|
120.0 gm/L
Standard Deviation 13.8
|
PRIMARY outcome
Timeframe: Month 9Population: All enrolled participants. Here, number of participants analyzed= participants with non-missing Hb assessment at specified time frame for this outcome measure.
Outcome measures
| Measure |
CKD Participants
n=106 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.
|
|---|---|
|
Mean Hb Value at Month 9 After Inclusion
|
120.0 gm/L
Standard Deviation 14.3
|
PRIMARY outcome
Timeframe: Month 12Population: All enrolled participants. Here, number of participants analyzed= participants with non-missing Hb assessment at specified time frame for this outcome measure.
Outcome measures
| Measure |
CKD Participants
n=110 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.
|
|---|---|
|
Mean Hb Value at Month 12 After Inclusion
|
118.4 gm/L
Standard Deviation 12.8
|
PRIMARY outcome
Timeframe: Pre-baseline (Month -6) to BaselinePopulation: All enrolled participants. Here, number of participants analyzed= participants with at least 2 non-missing Hb assessments between pre-baseline (Month -6) and baseline.
Hb fluctuation was defined as change in Hb value \>15 gm/L between 2 visits.
Outcome measures
| Measure |
CKD Participants
n=126 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.
|
|---|---|
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Percentage of Participants With Hb Fluctuation From Pre-Baseline (Month -6) to Baseline
|
36.5 percentage of participants
|
PRIMARY outcome
Timeframe: Baseline to Month 12Population: All enrolled participants. Here, number of participants analyzed= participants with at least 2 non-missing Hb assessments between baseline and Month 12.
Hb fluctuation was defined as change in Hb value \>15 gm/L between 2 visits.
Outcome measures
| Measure |
CKD Participants
n=117 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.
|
|---|---|
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Percentage of Participants With Hb Fluctuation From Baseline to Month 12
|
43.6 percentage of participants
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SECONDARY outcome
Timeframe: Months 3, 6, 9, and 12Population: All enrolled participants. Here, number of participants analyzed= participants evaluable for this outcome measure. n = number of participants evaluable at the specified time frame.
Change in MIRCERA treatment included changes in dose, frequency, and route of administration.
Outcome measures
| Measure |
CKD Participants
n=130 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.
|
|---|---|
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Percentage of Participants With Change in MIRCERA Treatment
Month 3 (n= 130)
|
43.1 percentage of participants
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|
Percentage of Participants With Change in MIRCERA Treatment
Month 6 (n= 117)
|
30.8 percentage of participants
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|
Percentage of Participants With Change in MIRCERA Treatment
Month 9 (n= 110)
|
22.7 percentage of participants
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|
Percentage of Participants With Change in MIRCERA Treatment
Month 12 (n= 112)
|
23.2 percentage of participants
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SECONDARY outcome
Timeframe: Baseline to Month 12Population: All enrolled participants. Here, number of participants analyzed= participants with available data for this outcome measure.
Outcome measures
| Measure |
CKD Participants
n=91 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.
|
|---|---|
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Percentage of Participants With Number of MIRCERA Dose Changes
No change
|
26.4 percentage of participants
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Percentage of Participants With Number of MIRCERA Dose Changes
One change
|
41.8 percentage of participants
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Percentage of Participants With Number of MIRCERA Dose Changes
Two changes
|
17.6 percentage of participants
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Percentage of Participants With Number of MIRCERA Dose Changes
Three changes
|
13.2 percentage of participants
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Percentage of Participants With Number of MIRCERA Dose Changes
Four changes
|
1.1 percentage of participants
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SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: The units usage at and between study centres did change during the study and therefore no descriptive statistics could be performed on the laboratory variables.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: The units usage at and between study centres did change during the study and therefore no descriptive statistics could be performed on the laboratory variables.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-baseline (Months -6 and -3), baseline, Months 3, 6, 9 and 12Population: All enrolled participants. Here, number of participants analyzed= participants evaluable for this outcome measure and n= participants evaluable for specified time points.
Percentage of participants who had any change in their iron supplement medication at a specified visit were reported.
Outcome measures
| Measure |
CKD Participants
n=142 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.
|
|---|---|
|
Percentage of Participants With Changes in Iron Supplement
Pre-baseline (Month -6) (n= 134)
|
31.3 percentage of participants
|
|
Percentage of Participants With Changes in Iron Supplement
Pre-baseline (Month -3) (n= 125)
|
12.8 percentage of participants
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Percentage of Participants With Changes in Iron Supplement
Baseline (n= 142)
|
15.5 percentage of participants
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Percentage of Participants With Changes in Iron Supplement
Month 3 (n= 130)
|
11.5 percentage of participants
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Percentage of Participants With Changes in Iron Supplement
Month 6 (n= 115)
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13.0 percentage of participants
|
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Percentage of Participants With Changes in Iron Supplement
Month 9 (n= 109)
|
9.2 percentage of participants
|
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Percentage of Participants With Changes in Iron Supplement
Month 12 (n= 112)
|
12.5 percentage of participants
|
SECONDARY outcome
Timeframe: Pre-baseline (Months -6 and -3), baseline, Months 3, 6, 9 and 12Population: All enrolled participants. Here, number of participants analyzed = participants evaluable for this outcome measure and n= participants evaluable for specified time points.
Percentage of participants who had any change in their immunosuppressive medication at a specified visit were reported.
Outcome measures
| Measure |
CKD Participants
n=142 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.
|
|---|---|
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Percentage of Participants With Changes in Immunosuppressive Treatment
Pre-baseline (Month -6) (n= 135)
|
23.0 percentage of participants
|
|
Percentage of Participants With Changes in Immunosuppressive Treatment
Pre-baseline (Month -3) (n= 125)
|
4.0 percentage of participants
|
|
Percentage of Participants With Changes in Immunosuppressive Treatment
Baseline (n= 142)
|
5.6 percentage of participants
|
|
Percentage of Participants With Changes in Immunosuppressive Treatment
Month 3 (n= 129)
|
8.5 percentage of participants
|
|
Percentage of Participants With Changes in Immunosuppressive Treatment
Month 6 (n= 114)
|
8.8 percentage of participants
|
|
Percentage of Participants With Changes in Immunosuppressive Treatment
Month 9 (n= 109)
|
2.8 percentage of participants
|
|
Percentage of Participants With Changes in Immunosuppressive Treatment
Month 12 (n= 111)
|
5.4 percentage of participants
|
SECONDARY outcome
Timeframe: Pre-baseline (Months -6 and -3), baseline, Months 3, 6, 9 and 12Population: All enrolled participants. Here, number of participants analyzed = participants evaluable for this outcome measure and n= participants evaluable for specified time points.
Percentage of participants who had any change in their antihypertensive medication at a specified visit were reported.
Outcome measures
| Measure |
CKD Participants
n=141 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.
|
|---|---|
|
Percentage of Participants With Changes in Antihypertensive Treatment
Pre-baseline (Month -6) (n= 135)
|
78.5 percentage of participants
|
|
Percentage of Participants With Changes in Antihypertensive Treatment
Pre-baseline (Month -3) (n= 125)
|
22.4 percentage of participants
|
|
Percentage of Participants With Changes in Antihypertensive Treatment
Baseline (n= 141)
|
22.7 percentage of participants
|
|
Percentage of Participants With Changes in Antihypertensive Treatment
Month 3 (n= 130)
|
12.3 percentage of participants
|
|
Percentage of Participants With Changes in Antihypertensive Treatment
Month 6 (n= 115)
|
13.0 percentage of participants
|
|
Percentage of Participants With Changes in Antihypertensive Treatment
Month 9 (n= 109)
|
16.5 percentage of participants
|
|
Percentage of Participants With Changes in Antihypertensive Treatment
Month 12 (n= 111)
|
19.8 percentage of participants
|
SECONDARY outcome
Timeframe: Pre-baseline (Month -6) to Month 12Population: All enrolled participants. Here, number of participants analyzed= participants evaluable for this outcome measure.
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.
Outcome measures
| Measure |
CKD Participants
n=142 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.
|
|---|---|
|
Number of Participants With Different Medication Treatment
Anti-hypertensive treatment
|
123 participants
|
|
Number of Participants With Different Medication Treatment
Immunosuppressive treatment
|
35 participants
|
|
Number of Participants With Different Medication Treatment
Iron treatment
|
71 participants
|
|
Number of Participants With Different Medication Treatment
Other treatment
|
55 participants
|
SECONDARY outcome
Timeframe: Pre-baseline (Months -6 and -3), baseline, Months 3, 6, 9 and 12Population: All enrolled participants. Here, number of participants analyzed= participants evaluable for this outcome measure and n= participants evaluable for specified time points.
Outcome measures
| Measure |
CKD Participants
n=142 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.
|
|---|---|
|
Percentage of Participants Who Required Blood Transfusion
Pre-baseline (Month -6) (n= 136)
|
0 percentage of participants
|
|
Percentage of Participants Who Required Blood Transfusion
Pre-baseline (Month -3) (n= 128)
|
2.3 percentage of participants
|
|
Percentage of Participants Who Required Blood Transfusion
Baseline (n= 142)
|
5.6 percentage of participants
|
|
Percentage of Participants Who Required Blood Transfusion
Month 3 (n= 131)
|
1.5 percentage of participants
|
|
Percentage of Participants Who Required Blood Transfusion
Month 6 (n= 115)
|
1.7 percentage of participants
|
|
Percentage of Participants Who Required Blood Transfusion
Month 9 (n= 109)
|
3.7 percentage of participants
|
|
Percentage of Participants Who Required Blood Transfusion
Month 12 (n= 110)
|
1.8 percentage of participants
|
SECONDARY outcome
Timeframe: Months 3, 6, 9, and 12Population: All enrolled participants. Here, number of participants analyzed= participants evaluable for this outcome measure and n= participants evaluable for specified time points.
Renal replacement therapy was defined as hemodialysis and peritoneal dialysis.
Outcome measures
| Measure |
CKD Participants
n=130 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.
|
|---|---|
|
Percentage of Participants Who Required Renal Replacement Therapy
Hemodialysis done: Month 3 (n= 130)
|
0.8 percentage of participants
|
|
Percentage of Participants Who Required Renal Replacement Therapy
Hemodialysis done: Month 6 (n= 113)
|
0.9 percentage of participants
|
|
Percentage of Participants Who Required Renal Replacement Therapy
Hemodialysis done: Month 9 (n= 107)
|
0.9 percentage of participants
|
|
Percentage of Participants Who Required Renal Replacement Therapy
Hemodialysis done: Month 12 (n= 110)
|
1.8 percentage of participants
|
|
Percentage of Participants Who Required Renal Replacement Therapy
Peritoneal dialysis done: Month 3 (n= 130)
|
0.8 percentage of participants
|
|
Percentage of Participants Who Required Renal Replacement Therapy
Peritoneal dialysis done: Month 6 (n= 113)
|
0 percentage of participants
|
|
Percentage of Participants Who Required Renal Replacement Therapy
Peritoneal dialysis done: Month 9 (n= 107)
|
0.9 percentage of participants
|
|
Percentage of Participants Who Required Renal Replacement Therapy
Peritoneal dialysis done: Month 12 (n= 110)
|
1.8 percentage of participants
|
Adverse Events
CKD Participants
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
CKD Participants
n=141 participants at risk
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.
|
|---|---|
|
Skin and subcutaneous tissue disorders
Skin Reaction
|
0.71%
1/141 • Pre-baseline (Month -6) to Month 12
All enrolled participants with data recorded for adverse events were included.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the study, but only after the first publication or presentation that involves the Overall Study. The sponsor may request that the confidential information be deleted and/or the publication to be postponed inorder to present the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER