Trial Outcomes & Findings for An Observational Study of Methoxy Polyethylene Glycol-epoetin Beta in Participants With a Kidney Transplant (NCT NCT02538107)
NCT ID: NCT02538107
Last Updated: 2017-06-07
Results Overview
Recruitment status
COMPLETED
Target enrollment
290 participants
Primary outcome timeframe
From Month 7 to Month 9
Results posted on
2017-06-07
Participant Flow
Participant milestones
| Measure |
Kidney Transplant Participants
Participants with chronic kidney disease who underwent kidney transplantation and received methoxy polyethylene glycol epoetin beta (Mircera) as part of their medical care were observed and documented for up to 15 months.
|
|---|---|
|
Overall Study
STARTED
|
290
|
|
Overall Study
COMPLETED
|
180
|
|
Overall Study
NOT COMPLETED
|
110
|
Reasons for withdrawal
| Measure |
Kidney Transplant Participants
Participants with chronic kidney disease who underwent kidney transplantation and received methoxy polyethylene glycol epoetin beta (Mircera) as part of their medical care were observed and documented for up to 15 months.
|
|---|---|
|
Overall Study
Did not receive any Mircera dose
|
11
|
|
Overall Study
Missing
|
5
|
|
Overall Study
Necessity of dialysis
|
20
|
|
Overall Study
Administration of other ESA
|
11
|
|
Overall Study
No further treatment necessary
|
18
|
|
Overall Study
Withdrawal by Subject
|
17
|
|
Overall Study
Death
|
4
|
|
Overall Study
Administrative reason
|
5
|
|
Overall Study
Adverse Event
|
4
|
|
Overall Study
Surgery
|
1
|
|
Overall Study
Other
|
7
|
|
Overall Study
Not recorded
|
7
|
Baseline Characteristics
An Observational Study of Methoxy Polyethylene Glycol-epoetin Beta in Participants With a Kidney Transplant
Baseline characteristics by cohort
| Measure |
Kidney Transplant Participants
n=279 Participants
Participants with chronic kidney disease who underwent kidney transplantation and received methoxy polyethylene glycol epoetin beta (Mircera) as part of their medical care were observed and documented for up to 15 months.
|
|---|---|
|
Age, Continuous
|
51.1 years
STANDARD_DEVIATION 14.07 • n=5 Participants
|
|
Sex: Female, Male
Female
|
137 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
142 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From Month 7 to Month 9Population: Efficacy analysis set (Included participants who reported no pregnancy during the study period and had dosing and hemoglobin data available during 1 of the 3 visits \[Visits 7-9\]).
Outcome measures
| Measure |
Kidney Transplant Participants
n=193 Participants
Participants with chronic kidney disease who underwent kidney transplantation and received methoxy polyethylene glycol epoetin beta (Mircera) as part of their medical care were observed and documented for up to 15 months.
|
Cadaveric Donation-Kidney Transplant Participants
Participants with chronic kidney disease who underwent 'cadaveric donation' type of kidney transplantation and received methoxy polyethylene glycol epoetin beta (Mircera) as part of their medical care were observed and documented for up to 15 months.
|
|---|---|---|
|
Percentage of Participants With a Hemoglobin Value of 11-12 Grams Per Deciliter (g/dL) From Visit 7 (Month 7) to Visit 9 (Month 9)
|
20.7 percentage of participants
|
—
|
PRIMARY outcome
Timeframe: From Month 7 to Month 9Population: Efficacy analysis set.
Outcome measures
| Measure |
Kidney Transplant Participants
n=193 Participants
Participants with chronic kidney disease who underwent kidney transplantation and received methoxy polyethylene glycol epoetin beta (Mircera) as part of their medical care were observed and documented for up to 15 months.
|
Cadaveric Donation-Kidney Transplant Participants
Participants with chronic kidney disease who underwent 'cadaveric donation' type of kidney transplantation and received methoxy polyethylene glycol epoetin beta (Mircera) as part of their medical care were observed and documented for up to 15 months.
|
|---|---|---|
|
Percentage of Participants With a Hemoglobin Value of 11-13 g/dL From Visit 7 (Month 7) to Visit 9 (Month 9)
|
40.4 percentage of participants
|
—
|
PRIMARY outcome
Timeframe: From Month 7 to Month 12Population: Efficacy analysis set. Participants who were evaluable at the specified time frame were included.
Outcome measures
| Measure |
Kidney Transplant Participants
n=137 Participants
Participants with chronic kidney disease who underwent kidney transplantation and received methoxy polyethylene glycol epoetin beta (Mircera) as part of their medical care were observed and documented for up to 15 months.
|
Cadaveric Donation-Kidney Transplant Participants
Participants with chronic kidney disease who underwent 'cadaveric donation' type of kidney transplantation and received methoxy polyethylene glycol epoetin beta (Mircera) as part of their medical care were observed and documented for up to 15 months.
|
|---|---|---|
|
Percentage of Participants With a Hemoglobin Value of 11-13 g/dL From Visit 7 (Month 7) to Visit 12 (Month 12)
|
21.2 percentage of participants
|
—
|
PRIMARY outcome
Timeframe: From Month 7 to Month 15Population: Efficacy analysis set. Participants who were evaluable at the specified time frame were included.
Outcome measures
| Measure |
Kidney Transplant Participants
n=131 Participants
Participants with chronic kidney disease who underwent kidney transplantation and received methoxy polyethylene glycol epoetin beta (Mircera) as part of their medical care were observed and documented for up to 15 months.
|
Cadaveric Donation-Kidney Transplant Participants
Participants with chronic kidney disease who underwent 'cadaveric donation' type of kidney transplantation and received methoxy polyethylene glycol epoetin beta (Mircera) as part of their medical care were observed and documented for up to 15 months.
|
|---|---|---|
|
Percentage of Participants With a Hemoglobin Value of 11-13 g/dL From Visit 7 (Month 7) to Visit 15 (Month 15)
|
12.2 percentage of participants
|
—
|
PRIMARY outcome
Timeframe: From Month 7 to Month 12Population: Efficacy analysis set. Participants who were evaluable at the specified time frame were included.
Outcome measures
| Measure |
Kidney Transplant Participants
n=137 Participants
Participants with chronic kidney disease who underwent kidney transplantation and received methoxy polyethylene glycol epoetin beta (Mircera) as part of their medical care were observed and documented for up to 15 months.
|
Cadaveric Donation-Kidney Transplant Participants
Participants with chronic kidney disease who underwent 'cadaveric donation' type of kidney transplantation and received methoxy polyethylene glycol epoetin beta (Mircera) as part of their medical care were observed and documented for up to 15 months.
|
|---|---|---|
|
Percentage of Participants With a Hemoglobin Value of 10-13 g/dL From Visit 7 (Month 7) to Visit 12 (Month 12)
|
52.6 percentage of participants
|
—
|
PRIMARY outcome
Timeframe: From Month 7 to Month 15Population: Efficacy analysis set. Participants who were evaluable at the specified time frame were included.
Outcome measures
| Measure |
Kidney Transplant Participants
n=131 Participants
Participants with chronic kidney disease who underwent kidney transplantation and received methoxy polyethylene glycol epoetin beta (Mircera) as part of their medical care were observed and documented for up to 15 months.
|
Cadaveric Donation-Kidney Transplant Participants
Participants with chronic kidney disease who underwent 'cadaveric donation' type of kidney transplantation and received methoxy polyethylene glycol epoetin beta (Mircera) as part of their medical care were observed and documented for up to 15 months.
|
|---|---|---|
|
Percentage of Participants With a Hemoglobin Value of 10-13 g/dL From Visit 7 (Month 7) to Visit 15 (Month 15)
|
41.2 percentage of participants
|
—
|
PRIMARY outcome
Timeframe: Up to 50 monthsPopulation: Efficacy analysis set. Participants with non-missing values were included.
Outcome measures
| Measure |
Kidney Transplant Participants
n=192 Participants
Participants with chronic kidney disease who underwent kidney transplantation and received methoxy polyethylene glycol epoetin beta (Mircera) as part of their medical care were observed and documented for up to 15 months.
|
Cadaveric Donation-Kidney Transplant Participants
Participants with chronic kidney disease who underwent 'cadaveric donation' type of kidney transplantation and received methoxy polyethylene glycol epoetin beta (Mircera) as part of their medical care were observed and documented for up to 15 months.
|
|---|---|---|
|
Average Duration in Months Mircera Was Administered at Current Dose After the Previous Dose Adjustment
|
9.31 months
Standard Deviation 6.250
|
—
|
SECONDARY outcome
Timeframe: Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11, Month 12, Month 13, Month 14, Month 15 and Entire study (Month 1 to Month 15)Population: Efficacy analysis set. n = number of participants who were evaluable at a particular visit.
Participants were classified based on the type of kidney transplantation they underwent before entering in to the study in to two groups; participants who received living donation and participants who received cadaveric donation.
Outcome measures
| Measure |
Kidney Transplant Participants
n=34 Participants
Participants with chronic kidney disease who underwent kidney transplantation and received methoxy polyethylene glycol epoetin beta (Mircera) as part of their medical care were observed and documented for up to 15 months.
|
Cadaveric Donation-Kidney Transplant Participants
n=159 Participants
Participants with chronic kidney disease who underwent 'cadaveric donation' type of kidney transplantation and received methoxy polyethylene glycol epoetin beta (Mircera) as part of their medical care were observed and documented for up to 15 months.
|
|---|---|---|
|
Hemoglobin Level Based on the Type of Kidney Transplantation Performed
Visit 1 (Month 1) (n=22, 113)
|
11.08 g/dL
Standard Deviation 1.244
|
11.26 g/dL
Standard Deviation 1.126
|
|
Hemoglobin Level Based on the Type of Kidney Transplantation Performed
Visit 2 (Month 2) (n=25, 118)
|
11.37 g/dL
Standard Deviation 1.215
|
11.41 g/dL
Standard Deviation 1.239
|
|
Hemoglobin Level Based on the Type of Kidney Transplantation Performed
Visit 3 (Month 3) (n=27, 128)
|
11.34 g/dL
Standard Deviation 1.163
|
11.71 g/dL
Standard Deviation 1.250
|
|
Hemoglobin Level Based on the Type of Kidney Transplantation Performed
Visit 4 (Month 4) (n=23, 128)
|
11.30 g/dL
Standard Deviation 1.213
|
11.56 g/dL
Standard Deviation 1.229
|
|
Hemoglobin Level Based on the Type of Kidney Transplantation Performed
Visit 5 (Month 5) (n=25, 122)
|
11.74 g/dL
Standard Deviation 1.174
|
11.75 g/dL
Standard Deviation 1.126
|
|
Hemoglobin Level Based on the Type of Kidney Transplantation Performed
Visit 6 (Month 6) (n=20, 113)
|
11.08 g/dL
Standard Deviation 0.896
|
11.66 g/dL
Standard Deviation 1.177
|
|
Hemoglobin Level Based on the Type of Kidney Transplantation Performed
Visit 7 (Month 7) (n=21, 121)
|
11.23 g/dL
Standard Deviation 1.132
|
11.59 g/dL
Standard Deviation 1.132
|
|
Hemoglobin Level Based on the Type of Kidney Transplantation Performed
Visit 8 (Month 8) (n=24, 113)
|
11.18 g/dL
Standard Deviation 1.305
|
11.57 g/dL
Standard Deviation 1.239
|
|
Hemoglobin Level Based on the Type of Kidney Transplantation Performed
Visit 9 (Month 9) (n=17, 125)
|
11.36 g/dL
Standard Deviation 1.386
|
11.60 g/dL
Standard Deviation 1.280
|
|
Hemoglobin Level Based on the Type of Kidney Transplantation Performed
Visit 10 (Month 10) (n=21, 107)
|
11.26 g/dL
Standard Deviation 1.435
|
11.59 g/dL
Standard Deviation 1.179
|
|
Hemoglobin Level Based on the Type of Kidney Transplantation Performed
Visit 11 (Month 11) (n=18, 99)
|
11.46 g/dL
Standard Deviation 1.079
|
11.62 g/dL
Standard Deviation 1.254
|
|
Hemoglobin Level Based on the Type of Kidney Transplantation Performed
Visit 12 (Month 12) (n=22, 110)
|
11.12 g/dL
Standard Deviation 1.437
|
11.41 g/dL
Standard Deviation 1.161
|
|
Hemoglobin Level Based on the Type of Kidney Transplantation Performed
Visit 13 (Month 13) (n=23, 100)
|
10.86 g/dL
Standard Deviation 1.386
|
11.32 g/dL
Standard Deviation 1.248
|
|
Hemoglobin Level Based on the Type of Kidney Transplantation Performed
Visit 14 (Month 14) (n=18, 101)
|
11.21 g/dL
Standard Deviation 1.018
|
11.35 g/dL
Standard Deviation 1.039
|
|
Hemoglobin Level Based on the Type of Kidney Transplantation Performed
Visit 15 (Month 15) (n=21, 84)
|
11.05 g/dL
Standard Deviation 1.187
|
11.50 g/dL
Standard Deviation 1.067
|
|
Hemoglobin Level Based on the Type of Kidney Transplantation Performed
Entire study (Month 1 to Month 15) (n=34, 159)
|
11.25 g/dL
Standard Deviation 0.853
|
11.49 g/dL
Standard Deviation 0.830
|
SECONDARY outcome
Timeframe: Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11, Month 12, Month 13, Month 14, Month 15 and Entire study (Month 1 to Month 15)Population: Efficacy analysis set. n = number of participants who were evaluable at a particular visit.
Participants were classified based on the presence of other inflammatory diseases at baseline in to two groups; participants with presence of inflammatory diseases and participants with absence of inflammatory diseases.
Outcome measures
| Measure |
Kidney Transplant Participants
n=56 Participants
Participants with chronic kidney disease who underwent kidney transplantation and received methoxy polyethylene glycol epoetin beta (Mircera) as part of their medical care were observed and documented for up to 15 months.
|
Cadaveric Donation-Kidney Transplant Participants
n=137 Participants
Participants with chronic kidney disease who underwent 'cadaveric donation' type of kidney transplantation and received methoxy polyethylene glycol epoetin beta (Mircera) as part of their medical care were observed and documented for up to 15 months.
|
|---|---|---|
|
Hemoglobin Level Based on the Presence of Inflammatory Diseases
Visit 1 (Month 1) (n=41, 94)
|
11.30 g/dL
Standard Deviation 1.168
|
11.20 g/dL
Standard Deviation 1.137
|
|
Hemoglobin Level Based on the Presence of Inflammatory Diseases
Visit 2 (Month 2) (n=43, 100)
|
11.33 g/dL
Standard Deviation 1.231
|
11.44 g/dL
Standard Deviation 1.236
|
|
Hemoglobin Level Based on the Presence of Inflammatory Diseases
Visit 3 (Month 3) (n=45, 110)
|
11.75 g/dL
Standard Deviation 1.419
|
11.61 g/dL
Standard Deviation 1.163
|
|
Hemoglobin Level Based on the Presence of Inflammatory Diseases
Visit 4 (Month 4) (n=47, 104)
|
11.54 g/dL
Standard Deviation 1.209
|
11.51 g/dL
Standard Deviation 1.240
|
|
Hemoglobin Level Based on the Presence of Inflammatory Diseases
Visit 5 (Month 5) (n=43, 104)
|
11.71 g/dL
Standard Deviation 1.135
|
11.76 g/dL
Standard Deviation 1.133
|
|
Hemoglobin Level Based on the Presence of Inflammatory Diseases
Visit 6 (Month 6) (n=42, 91)
|
11.34 g/dL
Standard Deviation 1.068
|
11.68 g/dL
Standard Deviation 1.184
|
|
Hemoglobin Level Based on the Presence of Inflammatory Diseases
Visit 7 (Month 7) (n=40, 102)
|
11.46 g/dL
Standard Deviation 1.276
|
11.56 g/dL
Standard Deviation 1.080
|
|
Hemoglobin Level Based on the Presence of Inflammatory Diseases
Visit 8 (Month 8) (n=40, 97)
|
11.58 g/dL
Standard Deviation 1.324
|
11.46 g/dL
Standard Deviation 1.230
|
|
Hemoglobin Level Based on the Presence of Inflammatory Diseases
Visit 9 (Month 9) (n=42, 100)
|
11.61 g/dL
Standard Deviation 1.236
|
11.55 g/dL
Standard Deviation 1.318
|
|
Hemoglobin Level Based on the Presence of Inflammatory Diseases
Visit 10 (Month 10) (n=34, 94)
|
11.63 g/dL
Standard Deviation 0.996
|
11.50 g/dL
Standard Deviation 1.300
|
|
Hemoglobin Level Based on the Presence of Inflammatory Diseases
Visit 11 (Month 11) (n=34, 83)
|
11.75 g/dL
Standard Deviation 1.015
|
11.53 g/dL
Standard Deviation 1.302
|
|
Hemoglobin Level Based on the Presence of Inflammatory Diseases
Visit 12 (Month 12) (n=33, 99)
|
11.23 g/dL
Standard Deviation 1.095
|
11.41 g/dL
Standard Deviation 1.248
|
|
Hemoglobin Level Based on the Presence of Inflammatory Diseases
Visit 13 (Month 13) (n=36, 87)
|
11.17 g/dL
Standard Deviation 1.129
|
11.26 g/dL
Standard Deviation 1.346
|
|
Hemoglobin Level Based on the Presence of Inflammatory Diseases
Visit 14 (Month 14) (n=31, 88)
|
11.07 g/dL
Standard Deviation 1.090
|
11.42 g/dL
Standard Deviation 1.003
|
|
Hemoglobin Level Based on the Presence of Inflammatory Diseases
Visit 15 (Month 15) (n=27, 78)
|
11.03 g/dL
Standard Deviation 1.157
|
11.55 g/dL
Standard Deviation 1.056
|
|
Hemoglobin Level Based on the Presence of Inflammatory Diseases
Entire study (Month 1 to Month 15) (n=56, 137)
|
11.38 g/dL
Standard Deviation 0.730
|
11.48 g/dL
Standard Deviation 0.878
|
SECONDARY outcome
Timeframe: Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11, Month 12, Month 13, Month 14, Month 15 and Entire study (Month 1 to Month 15)Population: Efficacy analysis set. Participants who were evaluable for the specified group were included and n = number of participants who were evaluable at a particular visit.
Participants were classified based on the etiology of chronic kidney disease. The different etiological reasons included diabetic vasculopathy, hypertensive nephrosclerosis, glomerulonephritis, polycystic kidney, chronic pyelonephritis, other reasons and origin unknown. Hemoglobin levels in participants who had etiology of chronic kidney disease as 'glomerulonephritis' or 'other reasons' were presented as these were the majority of the etiological reasons for chronic kidney disease.
Outcome measures
| Measure |
Kidney Transplant Participants
n=60 Participants
Participants with chronic kidney disease who underwent kidney transplantation and received methoxy polyethylene glycol epoetin beta (Mircera) as part of their medical care were observed and documented for up to 15 months.
|
Cadaveric Donation-Kidney Transplant Participants
n=55 Participants
Participants with chronic kidney disease who underwent 'cadaveric donation' type of kidney transplantation and received methoxy polyethylene glycol epoetin beta (Mircera) as part of their medical care were observed and documented for up to 15 months.
|
|---|---|---|
|
Hemoglobin Level Based on the Etiology of Chronic Kidney Disease
Visit 1 (Month 1) (n=43, 37)
|
11.27 g/dL
Standard Deviation 1.254
|
11.44 g/dL
Standard Deviation 1.149
|
|
Hemoglobin Level Based on the Etiology of Chronic Kidney Disease
Visit 2 (Month 2) (n=43, 40)
|
11.42 g/dL
Standard Deviation 1.240
|
11.48 g/dL
Standard Deviation 1.330
|
|
Hemoglobin Level Based on the Etiology of Chronic Kidney Disease
Visit 3 (Month 3) (n=49, 46)
|
11.79 g/dL
Standard Deviation 1.298
|
11.75 g/dL
Standard Deviation 1.266
|
|
Hemoglobin Level Based on the Etiology of Chronic Kidney Disease
Visit 4 (Month 4) (n=49, 41)
|
11.37 g/dL
Standard Deviation 1.270
|
11.76 g/dL
Standard Deviation 1.172
|
|
Hemoglobin Level Based on the Etiology of Chronic Kidney Disease
Visit 5 (Month 5) (n=46, 40)
|
11.88 g/dL
Standard Deviation 1.156
|
11.72 g/dL
Standard Deviation 1.172
|
|
Hemoglobin Level Based on the Etiology of Chronic Kidney Disease
Visit 6 (Month 6) (n=40, 36)
|
11.62 g/dL
Standard Deviation 1.129
|
11.68 g/dL
Standard Deviation 1.197
|
|
Hemoglobin Level Based on the Etiology of Chronic Kidney Disease
Visit 7 (Month 7) (n=46, 44)
|
11.71 g/dL
Standard Deviation 1.270
|
11.52 g/dL
Standard Deviation 1.227
|
|
Hemoglobin Level Based on the Etiology of Chronic Kidney Disease
Visit 8 (Month 8) (n=39, 35)
|
11.71 g/dL
Standard Deviation 1.305
|
11.60 g/dL
Standard Deviation 1.439
|
|
Hemoglobin Level Based on the Etiology of Chronic Kidney Disease
Visit 9 (Month 9) (n=45, 40)
|
11.88 g/dL
Standard Deviation 1.126
|
11.46 g/dL
Standard Deviation 1.594
|
|
Hemoglobin Level Based on the Etiology of Chronic Kidney Disease
Visit 10 (Month 10) (n=44, 31)
|
11.60 g/dL
Standard Deviation 1.266
|
11.67 g/dL
Standard Deviation 1.323
|
|
Hemoglobin Level Based on the Etiology of Chronic Kidney Disease
Visit 11 (Month 11) (n=33, 38)
|
11.96 g/dL
Standard Deviation 1.236
|
11.47 g/dL
Standard Deviation 1.327
|
|
Hemoglobin Level Based on the Etiology of Chronic Kidney Disease
Visit 12 (Month 12) (n=36, 41)
|
11.33 g/dL
Standard Deviation 1.452
|
11.37 g/dL
Standard Deviation 1.196
|
|
Hemoglobin Level Based on the Etiology of Chronic Kidney Disease
Visit 13 (Month 13) (n=41, 36)
|
11.32 g/dL
Standard Deviation 1.530
|
11.20 g/dL
Standard Deviation 1.208
|
|
Hemoglobin Level Based on the Etiology of Chronic Kidney Disease
Visit 14 (Month 14) (n=40, 33)
|
11.59 g/dL
Standard Deviation 1.077
|
11.26 g/dL
Standard Deviation 1.100
|
|
Hemoglobin Level Based on the Etiology of Chronic Kidney Disease
Visit 15 (Month 15) (n=35, 31)
|
11.40 g/dL
Standard Deviation 1.296
|
11.47 g/dL
Standard Deviation 1.140
|
|
Hemoglobin Level Based on the Etiology of Chronic Kidney Disease
Entire study (Month 1 to Month 15) (n=60, 55)
|
11.52 g/dL
Standard Deviation 0.924
|
11.52 g/dL
Standard Deviation 0.876
|
SECONDARY outcome
Timeframe: Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11, Month 12, Month 13, Month 14, Month 15 and Entire study (Month 1 to Month 15)Population: Efficacy analysis set. Participants who were evaluable for the specified group were included and n = number of participants who were evaluable at a particular visit.
Participants were classified in to two groups based on the presence of acute bleeding episodes during the study; presence or absence of bleeding episodes.
Outcome measures
| Measure |
Kidney Transplant Participants
n=192 Participants
Participants with chronic kidney disease who underwent kidney transplantation and received methoxy polyethylene glycol epoetin beta (Mircera) as part of their medical care were observed and documented for up to 15 months.
|
Cadaveric Donation-Kidney Transplant Participants
Participants with chronic kidney disease who underwent 'cadaveric donation' type of kidney transplantation and received methoxy polyethylene glycol epoetin beta (Mircera) as part of their medical care were observed and documented for up to 15 months.
|
|---|---|---|
|
Hemoglobin Level Based on the Acute Bleeding Episode(s) During the Study
Visit 1 (Month 1) (n=135, 0)
|
11.23 g/dL
Standard Deviation 1.143
|
—
|
|
Hemoglobin Level Based on the Acute Bleeding Episode(s) During the Study
Visit 2 (Month 2) (n=142, 0)
|
11.40 g/dL
Standard Deviation 1.231
|
—
|
|
Hemoglobin Level Based on the Acute Bleeding Episode(s) During the Study
Visit 3 (Month 3) (n=155, 0)
|
11.65 g/dL
Standard Deviation 1.240
|
—
|
|
Hemoglobin Level Based on the Acute Bleeding Episode(s) During the Study
Visit 4 (Month 4) (n=150, 0)
|
11.51 g/dL
Standard Deviation 1.229
|
—
|
|
Hemoglobin Level Based on the Acute Bleeding Episode(s) During the Study
Visit 5 (Month 5) (n=147, 0)
|
11.75 g/dL
Standard Deviation 1.130
|
—
|
|
Hemoglobin Level Based on the Acute Bleeding Episode(s) During the Study
Visit 6 (Month 6) (n=132, 0)
|
11.57 g/dL
Standard Deviation 1.159
|
—
|
|
Hemoglobin Level Based on the Acute Bleeding Episode(s) During the Study
Visit 7 (Month 7) (n=141, 0)
|
11.53 g/dL
Standard Deviation 1.139
|
—
|
|
Hemoglobin Level Based on the Acute Bleeding Episode(s) During the Study
Visit 8 (Month 8) (n=137, 0)
|
11.50 g/dL
Standard Deviation 1.254
|
—
|
|
Hemoglobin Level Based on the Acute Bleeding Episode(s) During the Study
Visit 9 (Month 9) (n=141, 0)
|
11.57 g/dL
Standard Deviation 1.294
|
—
|
|
Hemoglobin Level Based on the Acute Bleeding Episode(s) During the Study
Visit 10 (Month 10) (n=128, 0)
|
11.53 g/dL
Standard Deviation 1.224
|
—
|
|
Hemoglobin Level Based on the Acute Bleeding Episode(s) During the Study
Visit 11 (Month 11) (n=116, 0)
|
11.59 g/dL
Standard Deviation 1.231
|
—
|
|
Hemoglobin Level Based on the Acute Bleeding Episode(s) During the Study
Visit 12 (Month 12) (n=132, 0)
|
11.37 g/dL
Standard Deviation 1.210
|
—
|
|
Hemoglobin Level Based on the Acute Bleeding Episode(s) During the Study
Visit 13 (Month 13) (n=122, 0)
|
11.24 g/dL
Standard Deviation 1.285
|
—
|
|
Hemoglobin Level Based on the Acute Bleeding Episode(s) During the Study
Visit 14 (Month 14) (n=118, 0)
|
11.32 g/dL
Standard Deviation 1.035
|
—
|
|
Hemoglobin Level Based on the Acute Bleeding Episode(s) During the Study
Visit 15 (Month 15) (n=104, 0)
|
11.40 g/dL
Standard Deviation 1.101
|
—
|
|
Hemoglobin Level Based on the Acute Bleeding Episode(s) During the Study
Entire study (Month 1 to Month 15) (n=192, 0)
|
11.45 g/dL
Standard Deviation 0.839
|
—
|
SECONDARY outcome
Timeframe: Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11, Month 12, Month 13, Month 14, Month 15 and Entire study (Month 1 to Month 15)Population: Efficacy analysis set. Participants who were evaluable for the specified group were included and n = number of participants who were evaluable at a particular visit.
GFR is described as the flow rate of filtered fluid through the kidney and was determined using the Cockcroft-Gault formula to calculate the creatinine clearance. For males, creatinine clearance \[milliliters per minute (mL/min)\] = \[(140 minus age) multiplied by (\*) (body weight in kilogram \[kg\]) divided by \[72 \* serum creatinine milligrams per deciliter (mg/dL)\]. For females, creatinine clearance (mL/min) = 0.85 \* \[(140 minus age) \* (body weight in kg)\] divided by \[72 \* serum creatinine (mg/dL)\]. Participants were classified based on the GFR in to two groups; GFR less than (\<) 30 mL/min and in the range of 30-60 mL/min and hemoglobin levels at different visits were presented.
Outcome measures
| Measure |
Kidney Transplant Participants
n=46 Participants
Participants with chronic kidney disease who underwent kidney transplantation and received methoxy polyethylene glycol epoetin beta (Mircera) as part of their medical care were observed and documented for up to 15 months.
|
Cadaveric Donation-Kidney Transplant Participants
n=60 Participants
Participants with chronic kidney disease who underwent 'cadaveric donation' type of kidney transplantation and received methoxy polyethylene glycol epoetin beta (Mircera) as part of their medical care were observed and documented for up to 15 months.
|
|---|---|---|
|
Hemoglobin Level Based on the Glomerular Filtration Rate (GFR)
Visit 1 (Month 1) (n=35, 41)
|
11.15 g/dL
Standard Deviation 0.952
|
11.44 g/dL
Standard Deviation 1.200
|
|
Hemoglobin Level Based on the Glomerular Filtration Rate (GFR)
Visit 2 (Month 2) (n=35, 45)
|
11.17 g/dL
Standard Deviation 1.234
|
11.42 g/dL
Standard Deviation 1.103
|
|
Hemoglobin Level Based on the Glomerular Filtration Rate (GFR)
Visit 3 (Month 3) (n=40, 48)
|
11.60 g/dL
Standard Deviation 1.205
|
11.65 g/dL
Standard Deviation 0.954
|
|
Hemoglobin Level Based on the Glomerular Filtration Rate (GFR)
Visit 4 (Month 4) (n=37, 52)
|
11.26 g/dL
Standard Deviation 1.242
|
11.75 g/dL
Standard Deviation 1.086
|
|
Hemoglobin Level Based on the Glomerular Filtration Rate (GFR)
Visit 5 (Month 5) (n=37, 47)
|
11.40 g/dL
Standard Deviation 1.090
|
11.87 g/dL
Standard Deviation 1.104
|
|
Hemoglobin Level Based on the Glomerular Filtration Rate (GFR)
Visit 6 (Month 6) (n=34, 41)
|
11.32 g/dL
Standard Deviation 1.158
|
11.90 g/dL
Standard Deviation 1.257
|
|
Hemoglobin Level Based on the Glomerular Filtration Rate (GFR)
Visit 7 (Month 7) (n=36, 46)
|
11.46 g/dL
Standard Deviation 1.108
|
11.62 g/dL
Standard Deviation 1.223
|
|
Hemoglobin Level Based on the Glomerular Filtration Rate (GFR)
Visit 8 (Month 8) (n=28, 48)
|
11.46 g/dL
Standard Deviation 1.215
|
11.66 g/dL
Standard Deviation 1.165
|
|
Hemoglobin Level Based on the Glomerular Filtration Rate (GFR)
Visit 9 (Month 9) (n=38, 46)
|
11.50 g/dL
Standard Deviation 1.369
|
11.85 g/dL
Standard Deviation 1.161
|
|
Hemoglobin Level Based on the Glomerular Filtration Rate (GFR)
Visit 10 (Month 10) (n=30, 41)
|
11.22 g/dL
Standard Deviation 1.063
|
11.88 g/dL
Standard Deviation 0.992
|
|
Hemoglobin Level Based on the Glomerular Filtration Rate (GFR)
Visit 11 (Month 11) (n=30, 38)
|
11.55 g/dL
Standard Deviation 1.071
|
11.69 g/dL
Standard Deviation 1.126
|
|
Hemoglobin Level Based on the Glomerular Filtration Rate (GFR)
Visit 12 (Month 12) (n=27, 45)
|
11.41 g/dL
Standard Deviation 0.943
|
11.67 g/dL
Standard Deviation 1.038
|
|
Hemoglobin Level Based on the Glomerular Filtration Rate (GFR)
Visit 13 (Month 13) (n=31, 39)
|
11.44 g/dL
Standard Deviation 1.048
|
11.41 g/dL
Standard Deviation 1.363
|
|
Hemoglobin Level Based on the Glomerular Filtration Rate (GFR)
Visit 14 (Month 14) (n=27, 41)
|
11.29 g/dL
Standard Deviation 1.056
|
11.40 g/dL
Standard Deviation 1.089
|
|
Hemoglobin Level Based on the Glomerular Filtration Rate (GFR)
Visit 15 (Month 15) (n=24, 35)
|
11.20 g/dL
Standard Deviation 1.093
|
11.81 g/dL
Standard Deviation 0.993
|
|
Hemoglobin Level Based on the Glomerular Filtration Rate (GFR)
Entire study (Month 1 to Month 15) (n=46, 60)
|
11.26 g/dL
Standard Deviation 0.784
|
11.62 g/dL
Standard Deviation 0.716
|
Adverse Events
Kidney Transplant Participants
Serious events: 32 serious events
Other events: 42 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Kidney Transplant Participants
n=279 participants at risk
Participants with chronic kidney disease who underwent kidney transplantation and received methoxy polyethylene glycol epoetin beta (Mircera) as part of their medical care were observed and documented for up to 15 months.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.36%
1/279 • Up to 50 months
Safety analysis set.
|
|
Cardiac disorders
Angina pectoris
|
0.36%
1/279 • Up to 50 months
Safety analysis set.
|
|
Cardiac disorders
Angina unstable
|
0.36%
1/279 • Up to 50 months
Safety analysis set.
|
|
Cardiac disorders
Coronary artery disease
|
0.36%
1/279 • Up to 50 months
Safety analysis set.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.72%
2/279 • Up to 50 months
Safety analysis set.
|
|
General disorders
Chest pain
|
0.36%
1/279 • Up to 50 months
Safety analysis set.
|
|
General disorders
Device failure
|
0.36%
1/279 • Up to 50 months
Safety analysis set.
|
|
General disorders
Inflammation
|
0.36%
1/279 • Up to 50 months
Safety analysis set.
|
|
General disorders
Multi-organ failure
|
0.36%
1/279 • Up to 50 months
Safety analysis set.
|
|
General disorders
Sudden cardiac death
|
0.36%
1/279 • Up to 50 months
Safety analysis set.
|
|
Immune system disorders
Kidney transplant rejection
|
0.36%
1/279 • Up to 50 months
Safety analysis set.
|
|
Infections and infestations
Cytomegalovirus infection
|
0.36%
1/279 • Up to 50 months
Safety analysis set.
|
|
Infections and infestations
Gastroenteritis
|
0.72%
2/279 • Up to 50 months
Safety analysis set.
|
|
Infections and infestations
Gastroenteritis norovirus
|
0.36%
1/279 • Up to 50 months
Safety analysis set.
|
|
Infections and infestations
Human polyomavirus infection
|
0.36%
1/279 • Up to 50 months
Safety analysis set.
|
|
Infections and infestations
Intervertebral discitis
|
0.36%
1/279 • Up to 50 months
Safety analysis set.
|
|
Infections and infestations
Pneumonia
|
1.8%
5/279 • Up to 50 months
Safety analysis set.
|
|
Infections and infestations
Sepsis
|
0.36%
1/279 • Up to 50 months
Safety analysis set.
|
|
Infections and infestations
Septic shock
|
0.36%
1/279 • Up to 50 months
Safety analysis set.
|
|
Infections and infestations
Urinary tract infection
|
1.1%
3/279 • Up to 50 months
Safety analysis set.
|
|
Infections and infestations
Urinary tract infection enterococcal
|
0.36%
1/279 • Up to 50 months
Safety analysis set.
|
|
Infections and infestations
Urosepsis
|
0.36%
1/279 • Up to 50 months
Safety analysis set.
|
|
Infections and infestations
Varicella
|
0.36%
1/279 • Up to 50 months
Safety analysis set.
|
|
Infections and infestations
Wound infection
|
0.36%
1/279 • Up to 50 months
Safety analysis set.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.36%
1/279 • Up to 50 months
Safety analysis set.
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.36%
1/279 • Up to 50 months
Safety analysis set.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.36%
1/279 • Up to 50 months
Safety analysis set.
|
|
Investigations
Blood creatinine increased
|
1.4%
4/279 • Up to 50 months
Safety analysis set.
|
|
Investigations
C-reactive protein increased
|
0.36%
1/279 • Up to 50 months
Safety analysis set.
|
|
Investigations
Haemoglobin decreased
|
0.72%
2/279 • Up to 50 months
Safety analysis set.
|
|
Investigations
Weight decreased
|
0.36%
1/279 • Up to 50 months
Safety analysis set.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.36%
1/279 • Up to 50 months
Safety analysis set.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.36%
1/279 • Up to 50 months
Safety analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papilloma
|
0.36%
1/279 • Up to 50 months
Safety analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.36%
1/279 • Up to 50 months
Safety analysis set.
|
|
Nervous system disorders
Cerebral infarction
|
0.36%
1/279 • Up to 50 months
Safety analysis set.
|
|
Nervous system disorders
Headache
|
0.36%
1/279 • Up to 50 months
Safety analysis set.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.36%
1/279 • Up to 50 months
Safety analysis set.
|
|
Nervous system disorders
VIth nerve disorder
|
0.36%
1/279 • Up to 50 months
Safety analysis set.
|
|
Renal and urinary disorders
Renal failure
|
0.36%
1/279 • Up to 50 months
Safety analysis set.
|
|
Renal and urinary disorders
Renal failure acute
|
0.36%
1/279 • Up to 50 months
Safety analysis set.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.36%
1/279 • Up to 50 months
Safety analysis set.
|
|
Surgical and medical procedures
Dialysis
|
0.36%
1/279 • Up to 50 months
Safety analysis set.
|
|
Surgical and medical procedures
Haemodialysis
|
0.36%
1/279 • Up to 50 months
Safety analysis set.
|
|
Surgical and medical procedures
Parathyroidectomy
|
0.36%
1/279 • Up to 50 months
Safety analysis set.
|
|
Vascular disorders
Deep vein thrombosis
|
0.36%
1/279 • Up to 50 months
Safety analysis set.
|
|
Vascular disorders
Hypertension
|
0.36%
1/279 • Up to 50 months
Safety analysis set.
|
Other adverse events
| Measure |
Kidney Transplant Participants
n=279 participants at risk
Participants with chronic kidney disease who underwent kidney transplantation and received methoxy polyethylene glycol epoetin beta (Mircera) as part of their medical care were observed and documented for up to 15 months.
|
|---|---|
|
Blood and lymphatic system disorders
Bone marrow failure
|
0.36%
1/279 • Up to 50 months
Safety analysis set.
|
|
Blood and lymphatic system disorders
Haemolytic anaemia
|
0.36%
1/279 • Up to 50 months
Safety analysis set.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.36%
1/279 • Up to 50 months
Safety analysis set.
|
|
Blood and lymphatic system disorders
Macrocytosis
|
0.36%
1/279 • Up to 50 months
Safety analysis set.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.36%
1/279 • Up to 50 months
Safety analysis set.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.36%
1/279 • Up to 50 months
Safety analysis set.
|
|
Cardiac disorders
Palpitations
|
0.36%
1/279 • Up to 50 months
Safety analysis set.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.36%
1/279 • Up to 50 months
Safety analysis set.
|
|
Ear and labyrinth disorders
Tympanic membrane disorder
|
0.36%
1/279 • Up to 50 months
Safety analysis set.
|
|
Ear and labyrinth disorders
Vertigo
|
0.36%
1/279 • Up to 50 months
Safety analysis set.
|
|
Eye disorders
Diplopia
|
0.36%
1/279 • Up to 50 months
Safety analysis set.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.36%
1/279 • Up to 50 months
Safety analysis set.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.72%
2/279 • Up to 50 months
Safety analysis set.
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
0.36%
1/279 • Up to 50 months
Safety analysis set.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.9%
8/279 • Up to 50 months
Safety analysis set.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.72%
2/279 • Up to 50 months
Safety analysis set.
|
|
Gastrointestinal disorders
Nausea
|
1.4%
4/279 • Up to 50 months
Safety analysis set.
|
|
Gastrointestinal disorders
Vomiting
|
0.36%
1/279 • Up to 50 months
Safety analysis set.
|
|
General disorders
Fatigue
|
0.72%
2/279 • Up to 50 months
Safety analysis set.
|
|
General disorders
Gait disturbance
|
0.36%
1/279 • Up to 50 months
Safety analysis set.
|
|
General disorders
Influenza like illness
|
1.4%
4/279 • Up to 50 months
Safety analysis set.
|
|
General disorders
Injection site pain
|
0.36%
1/279 • Up to 50 months
Safety analysis set.
|
|
General disorders
Malaise
|
0.36%
1/279 • Up to 50 months
Safety analysis set.
|
|
General disorders
Oedema peripheral
|
0.36%
1/279 • Up to 50 months
Safety analysis set.
|
|
General disorders
Pyrexia
|
0.36%
1/279 • Up to 50 months
Safety analysis set.
|
|
Infections and infestations
Bronchitis
|
0.36%
1/279 • Up to 50 months
Safety analysis set.
|
|
Infections and infestations
Febrile infection
|
0.36%
1/279 • Up to 50 months
Safety analysis set.
|
|
Infections and infestations
Gastroenteritis
|
0.36%
1/279 • Up to 50 months
Safety analysis set.
|
|
Infections and infestations
Herpes simplex
|
0.36%
1/279 • Up to 50 months
Safety analysis set.
|
|
Infections and infestations
Herpes zoster
|
0.36%
1/279 • Up to 50 months
Safety analysis set.
|
|
Infections and infestations
Localised infection
|
0.36%
1/279 • Up to 50 months
Safety analysis set.
|
|
Infections and infestations
Molluscum contagiosum
|
0.36%
1/279 • Up to 50 months
Safety analysis set.
|
|
Infections and infestations
Nasopharyngitis
|
3.2%
9/279 • Up to 50 months
Safety analysis set.
|
|
Infections and infestations
Oral herpes
|
1.1%
3/279 • Up to 50 months
Safety analysis set.
|
|
Infections and infestations
Otitis media
|
0.36%
1/279 • Up to 50 months
Safety analysis set.
|
|
Infections and infestations
Sinusitis
|
0.36%
1/279 • Up to 50 months
Safety analysis set.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.72%
2/279 • Up to 50 months
Safety analysis set.
|
|
Infections and infestations
Urinary tract infection
|
2.2%
6/279 • Up to 50 months
Safety analysis set.
|
|
Injury, poisoning and procedural complications
Epicondylitis
|
0.36%
1/279 • Up to 50 months
Safety analysis set.
|
|
Injury, poisoning and procedural complications
Shunt occlusion
|
0.36%
1/279 • Up to 50 months
Safety analysis set.
|
|
Investigations
Haemoglobin decreased
|
0.36%
1/279 • Up to 50 months
Safety analysis set.
|
|
Investigations
Liver function test abnormal
|
0.36%
1/279 • Up to 50 months
Safety analysis set.
|
|
Investigations
Weight decreased
|
0.36%
1/279 • Up to 50 months
Safety analysis set.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.72%
2/279 • Up to 50 months
Safety analysis set.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.36%
1/279 • Up to 50 months
Safety analysis set.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.36%
1/279 • Up to 50 months
Safety analysis set.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.72%
2/279 • Up to 50 months
Safety analysis set.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.36%
1/279 • Up to 50 months
Safety analysis set.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.36%
1/279 • Up to 50 months
Safety analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.36%
1/279 • Up to 50 months
Safety analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm skin
|
0.36%
1/279 • Up to 50 months
Safety analysis set.
|
|
Nervous system disorders
Headache
|
0.36%
1/279 • Up to 50 months
Safety analysis set.
|
|
Nervous system disorders
Hypoaesthesia
|
0.72%
2/279 • Up to 50 months
Safety analysis set.
|
|
Nervous system disorders
Phantom pain
|
0.36%
1/279 • Up to 50 months
Safety analysis set.
|
|
Nervous system disorders
Psychomotor hyperactivity
|
0.36%
1/279 • Up to 50 months
Safety analysis set.
|
|
Nervous system disorders
Tremor
|
0.36%
1/279 • Up to 50 months
Safety analysis set.
|
|
Psychiatric disorders
Depression
|
0.36%
1/279 • Up to 50 months
Safety analysis set.
|
|
Renal and urinary disorders
Dysuria
|
0.36%
1/279 • Up to 50 months
Safety analysis set.
|
|
Renal and urinary disorders
Nephrotic syndrome
|
0.36%
1/279 • Up to 50 months
Safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.4%
4/279 • Up to 50 months
Safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.36%
1/279 • Up to 50 months
Safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.36%
1/279 • Up to 50 months
Safety analysis set.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.36%
1/279 • Up to 50 months
Safety analysis set.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.36%
1/279 • Up to 50 months
Safety analysis set.
|
|
Skin and subcutaneous tissue disorders
Hirsutism
|
0.36%
1/279 • Up to 50 months
Safety analysis set.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.36%
1/279 • Up to 50 months
Safety analysis set.
|
|
Skin and subcutaneous tissue disorders
Night Sweats
|
0.36%
1/279 • Up to 50 months
Safety analysis set.
|
|
Social circumstances
Walking disability
|
0.36%
1/279 • Up to 50 months
Safety analysis set.
|
|
Surgical and medical procedures
Carpal tunnel decompression
|
0.36%
1/279 • Up to 50 months
Safety analysis set.
|
|
Vascular disorders
Hypertension
|
0.72%
2/279 • Up to 50 months
Safety analysis set.
|
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 Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER