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A Study of Once Monthly Intravenous Mircera for the Maintenance Treatment of Dialysis Patients With Chronic Renal Anemia.

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ClinicalTrials.gov Identifier: NCT00737464
Recruitment Status : Completed
First Posted : August 19, 2008
Results First Posted : April 29, 2016
Last Update Posted : December 7, 2017
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Anemia
Intervention Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
Enrollment 132
Recruitment Details A total of 132 participants were enrolled from 26 August 2008 to 12 September 2009 at 11 study sites in India.
Pre-assignment Details  
Arm/Group Title Mircera
Hide Arm/Group Description Eligible participants with chronic renal anemia were administered methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks.
Period Title: Overall Study
Started 132
Completed 114
Not Completed 18
Reason Not Completed
Adverse Event             1
Death             6
Other - Failure to Return             1
Refused Treatment / Withdrew Consent             6
Other reasons             4
Arm/Group Title Mircera
Hide Arm/Group Description Eligible participants with chronic renal anemia were administered methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks.
Overall Number of Baseline Participants 132
Hide Baseline Analysis Population Description
Safety population included all enrolled participants who received at least one dose of study medication.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 132 participants
52.74  (12.40)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 132 participants
Female
35
  26.5%
Male
97
  73.5%
1.Primary Outcome
Title Percentage of Participants Maintaining Mean Hemoglobin Levels Within the Target Range During the Last 4 Weeks of the Treatment Period (Weeks 8 to 12)
Hide Description Participants maintaining mean hemoglobin (Hb) concentration within the target range i.e. 10.0 - 12.0 gram per deciliter (g/dL) during last 4 weeks (Weeks 8 to 12) of treatment period (TP) were reported. Total duration for treatment period was 12 weeks. Stability verification period of 2-weeks was conducted before treatment period. The reference Hb concentrations were based upon the mean of the assessments at Weeks -2, -1 and Week 0. The target range for assessment was set at the reference value Hb +/- 1 g/dL but not >12.0 g/dL and not <10.0 g/dL.
Time Frame Weeks 8 to 12 (Last 4 weeks of treatment period)
Hide Outcome Measure Data
Hide Analysis Population Description
Per-protocol (PP) population comprised of participants who had received at least 1 dose of MIRCERA (Week 0) and for whom data for at least one follow-up variable was available and who had completed the study.
Arm/Group Title Mircera
Hide Arm/Group Description:
Eligible participants were administered methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks.
Overall Number of Participants Analyzed 114
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
57.89
(48.29 to 67.08)
2.Secondary Outcome
Title Mean Hemoglobin Concentration Between Stability Verification Period (Weeks -2 to -1) and Treatment Period (Weeks 8 to 12)
Hide Description The mean change in Hb concentration between reference stability verification period (SVP) and in last 4 weeks (Weeks 8 to 12) of treatment period (TP) was reported. Duration for SVP was 2 weeks followed by treatment period of 12 weeks. The reference Hb concentrations were based upon the mean of the assessments at Weeks -2, -1 and Week 0. The target range for assessment was set at the reference value hemoglobin +/- 1 g/dL but not >12.0 g/dL and not <10.0 g/dL.
Time Frame SVP (Weeks -2 to -1) and TP (Weeks 8 to 12)
Hide Outcome Measure Data
Hide Analysis Population Description
Per-protocol (PP) population comprised of participants who had received at least 1 dose of MIRCERA (Week 0) and for whom data for at least one follow-up variable was available and who had completed the study.
Arm/Group Title Mircera
Hide Arm/Group Description:
Eligible participants were administered methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks.
Overall Number of Participants Analyzed 114
Mean (Standard Deviation)
Unit of Measure: gm/dL
Hb in SVP 10.76  (0.75)
Avg of Hb in Last 4 Weeks TP 11.28  (1.22)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mircera
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.52
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Mean Time Participants Spent Having Hemoglobin Range of 10.0 to 12.0 g/dL
Hide Description Mean time participants spent having hemoglobin range of 10.0 to 12.0 g/dL was reported. The reference Hb concentrations were based upon the mean of the assessments at Weeks -2, -1 and Week 0. The target range for assessment was set at the reference value hemoglobin +/- 1 gram per deciliter but not >12.0 g/dL and not <10.0 g/dL.
Time Frame Up to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Per-protocol (PP) population comprised of participants who had received at least 1 dose of MIRCERA (Week 0) and for whom data for at least one follow-up variable was available and who had completed the study.
Arm/Group Title Mircera
Hide Arm/Group Description:
Eligible participants were administered methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks.
Overall Number of Participants Analyzed 114
Mean (Standard Deviation)
Unit of Measure: Weeks
3.15  (1.00)
4.Secondary Outcome
Title Number of Participants With Treatment Emergent Adverse Events, Serious Adverse Events and Deaths
Hide Description Participants with treatment emergent adverse events (TEAEs), serious adverse events (SAEs) and deaths in the overall study were reported. An Adverse Event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Time Frame Up to Week 14
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all enrolled participants who received at least one dose of study drug.
Arm/Group Title Mircera
Hide Arm/Group Description:
Eligible participants were administered methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks.
Overall Number of Participants Analyzed 132
Measure Type: Number
Unit of Measure: Number of participants
TEAEs 27
SAEs 9
Deaths 3
5.Secondary Outcome
Title Mean Change From Baseline in Heart Rate Over Time
Hide Description Mean change from Baseline (Week -1) to end of the treatment (Week 12) in heart rate was reported. Baseline measure was considered as (Week -1) evaluation for this parameter.
Time Frame From Baseline (Week -1) to Weeks 0, 1, 2, 4, 6, 8, 10, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all enrolled participants who received at least one dose of study drug. n = number of participants analyzed at a given time point.
Arm/Group Title Mircera
Hide Arm/Group Description:
Eligible participants were administered methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks.
Overall Number of Participants Analyzed 132
Mean (Standard Deviation)
Unit of Measure: Beats per minute (bpm)
Heart rate, Week -1, (n = 132) 78.79  (7.12)
Heart rate, Week 0, (n = 131) 79.54  (7.27)
Heart rate, Week 1, (n = 129) 78.64  (6.92)
Heart rate, Week 2, (n = 124) 78.98  (7.83)
Heart rate, Week 4, (n = 124) 78.61  (6.92)
Heart rate, Week 6, (n = 121) 79.55  (8.37)
Heart rate, Week 8, (n = 118) 79.83  (7.55)
Heart rate, Week 10, (n = 115) 79.56  (7.54)
Heart rate, Week 12, (n = 115) 79.80  (7.65)
6.Secondary Outcome
Title Mean Change From Baseline in Blood Pressure (Systolic Blood Pressure and Diastolic Blood Pressure) Over Time
Hide Description Mean change from Baseline (Week -2) to end of the treatment (Week 12) in systolic blood pressure (SBP) and diastolic blood pressure (DBP) before and after dialysis was reported. Baseline measure was considered as (Week -2) evaluation for this parameter.
Time Frame From Baseline (Week -2) to Weeks -1, 0, 1, 2, 4, 6, 8, 10, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all enrolled participants who received at least one dose of study drug. n = the number of participants analyzed at a given time point.
Arm/Group Title Mircera
Hide Arm/Group Description:
Eligible participants were administered methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks.
Overall Number of Participants Analyzed 132
Mean (Standard Deviation)
Unit of Measure: mmHg
SBP, Week-2, Before Dialysis (n = 132) 145.04  (15.71)
SBP, Week-2, After Dialysis (n = 131) 145.51  (18.12)
SBP, Week-1, Before Dialysis (n = 132) 146.72  (14.77)
SBP, Week-1, After Dialysis (n =131) 143.26  (18.72)
SBP, Week 0, Before Dialysis (n = 131) 145.05  (16.04)
SBP, Week 0, After Dialysis (n = 130) 143.75  (16.96)
SBP, Week 1, Before Dialysis (n = 129) 147.02  (17.40)
SBP, Week 1, After Dialysis (n = 128) 144.02  (17.68)
SBP, Week 2, Before Dialysis (n = 124) 146.85  (18.08)
SBP, Week 2, After Dialysis (n = 123) 144.92  (18.44)
SBP, Week 4, Before Dialysis (n = 124) 146.68  (16.98)
SBP, Week 4, After Dialysis (n = 124) 143.65  (18.18)
SBP, Week 6, Before Dialysis (n = 121) 145.16  (18.58)
SBP, Week 6, After Dialysis (n = 121) 145.55  (20.64)
SBP, Week 8, Before Dialysis (n = 118) 144.77  (18.84)
SBP, Week 8, After Dialysis (n = 118) 143.42  (17.14)
SBP, Week 10, Before Dialysis (n = 115) 144.14  (17.57)
SBP, Week 10, After Dialysis (n = 115) 143.98  (17.44)
SBP, Week 12, Before Dialysis (n = 115) 144.55  (18.46)
SBP, Week 12, After Dialysis (n = 115) 143.80  (18.22)
DBP, Week -2, Before Dialysis (n = 132) 82.92  (9.32)
DBP, Week -2, After Dialysis (n = 131) 84.05  (9.40)
DBP, Week -1, Before Dialysis (n = 132) 83.90  (9.80)
DBP, Week -1, After Dialysis (n = 131) 83.22  (9.51)
DBP, Week 0, Before Dialysis (n = 131) 84.05  (8.57)
DBP, Week 0, After Dialysis (n = 130) 84.04  (8.94)
DBP, Week 1, Before Dialysis (n = 129) 84.68  (9.34)
DBP, Week 1, After Dialysis (n = 128) 83.27  (8.97)
DBP, Week 2, Before Dialysis (n = 124) 83.77  (8.62)
DBP, Week 2, After Dialysis (n = 123) 83.69  (8.85)
DBP, Week 4, Before Dialysis (n = 124) 84.15  (8.98)
DBP, Week 4, After Dialysis (n = 124) 83.29  (9.27)
DBP, Week 6, Before Dialysis (n = 121) 83.31  (8.98)
DBP, Week 6, After Dialysis (n = 121) 83.97  (9.24)
DBP, Week 8, Before Dialysis (n = 118) 83.28  (9.49)
DBP, Week 8, After Dialysis (n = 118) 84.35  (8.03)
DBP, Week 10, Before Dialysis (n = 115) 83.91  (8.55)
DBP, Week 10, After Dialysis (n = 115) 84.33  (9.24)
DBP, Week 12, Before Dialysis (n = 115) 84.17  (10.47)
DBP, Week 12, After Dialysis (n = 115) 83.23  (9.45)
7.Secondary Outcome
Title Number of Participants With Abnormal Electrocardiogram
Hide Description Participants with abnormal electrocardiogram were reported.
Time Frame At Week -2 and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all enrolled participants who received at least one dose of study drug. n = the number of participants analyzed at a given time point.
Arm/Group Title Mircera
Hide Arm/Group Description:
Eligible participants were administered methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks.
Overall Number of Participants Analyzed 132
Measure Type: Number
Unit of Measure: Number of participants
Week -2 (n=132) 61
Week 12 (n=115) 50
8.Secondary Outcome
Title Mean Values of White Blood Cells and Platelets Over Time
Hide Description Mean values of white blood cells (WBCs), and platelets at Weeks -2, 4, 8, and 12 were reported.
Time Frame At Weeks -2, 4, 8, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all enrolled participants who received at least one dose of study drug. n = number of participants analyzed at a given time point.
Arm/Group Title Mircera
Hide Arm/Group Description:
Eligible participants were administered methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks.
Overall Number of Participants Analyzed 132
Mean (Standard Deviation)
Unit of Measure: Per cubic millimeter
WBCs, Week -2 (n = 132) 7527.50  (2444.43)
WBCs, Week 4 (n = 114) 7369.74  (2470.21)
WBCs, Week 8 (n = 118) 7506.61  (2214.38)
WBCs, Week 12 (n = 115) 7484.35  (2130.22)
Platelets, Week -2 (n = 132) 211772.73  (73360.93)
Platelets, Week 4 (n = 114) 199508.77  (64724.91)
Platelets, Week 8 (n = 118) 208745.76  (67546.15)
Platelets, Week 12 (n = 115) 208566.37  (102269.07)
9.Secondary Outcome
Title Mean Values of Hypochromic Red Blood Cells Over Time
Hide Description Mean values of hypochromic red blood cells (RBCs) at Weeks -2, 4, 8, and 12 were reported.
Time Frame At Weeks -2, 4, 8, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all enrolled participants who received at least one dose of study drug. n = number of participants analyzed at a given time point.
Arm/Group Title Mircera
Hide Arm/Group Description:
Eligible participants were administered methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks.
Overall Number of Participants Analyzed 42
Mean (Standard Deviation)
Unit of Measure: Percentage of RBCs
Hypochromic RBCs, Week -2 (n = 41) 3.58  (0.43)
Hypochromic RBCs, Week 4 (n = 34) 3.73  (0.57)
Hypochromic RBCs, Week 8 (n = 42) 3.88  (0.59)
Hypochromic RBCs, Week 12 (n = 42) 3.97  (0.73)
10.Secondary Outcome
Title Mean Corpuscular Volume Levels Over Time
Hide Description Mean corpuscular volume (MCV) is a measure of the average red blood cell volume. MCV levels at Weeks -2, 4, 8, and 12 were reported.
Time Frame At Weeks -2, 4, 8, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all enrolled participants who received at least one dose of study drug. n = number of participants analyzed at a given time point.
Arm/Group Title Mircera
Hide Arm/Group Description:
Eligible participants were administered methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks.
Overall Number of Participants Analyzed 125
Mean (Standard Deviation)
Unit of Measure: femtoliters
MCV, Week -2 (n = 125) 90.32  (7.32)
MCV, Week 4 (n = 107) 89.99  (7.53)
MCV, Week 8 (n = 112) 89.41  (7.04)
MCV, Week 12 (n = 108) 88.09  (8.79)
11.Secondary Outcome
Title Mean Values of Iron Parameters (Serum Iron and Total Iron Binding Capacity) Over Time
Hide Description Mean values of serum iron and total iron binding capacity (TIBC) were reported.
Time Frame At Weeks -2, 4, 8, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all enrolled participants who received at least one dose of study drug. n = number of participants analyzed at a given time point.
Arm/Group Title Mircera
Hide Arm/Group Description:
Eligible participants were administered methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks.
Overall Number of Participants Analyzed 131
Mean (Standard Deviation)
Unit of Measure: microgram per deciliter
Serum Iron, Week -2 (n = 131) 102.13  (77.47)
Serum Iron, Week 4 (n = 122) 108.56  (59.65)
Serum Iron, Week 8 (n = 118) 116.79  (67.96)
Serum Iron, Week 12 (n = 112) 110.53  (56.31)
TIBC, Week -2 (n = 131) 273.44  (114.36)
TIBC, Week 4 (n = 122) 266.98  (116.69)
TIBC, Week 8 (n = 115) 283.50  (133.49)
TIBC, Week 12 (n = 112) 276.43  (118.54)
12.Secondary Outcome
Title Mean Values of Serum Ferritin Over Time
Hide Description Mean values of serum ferritin were reported.
Time Frame At Weeks -2, 4, 8, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all enrolled participants who received at least one dose of study drug. n = number of participants analyzed at a given time point.
Arm/Group Title Mircera
Hide Arm/Group Description:
Eligible participants were administered methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks.
Overall Number of Participants Analyzed 126
Mean (Standard Deviation)
Unit of Measure: nanogram per mililiter
Serum Ferritin, Week -2 (n = 126) 1806.30  (6418.97)
Serum Ferritin, Week 4 (n = 117) 1422.48  (2550.43)
Serum Ferritin, Week 8 (n = 109) 1109.07  (1050.90)
Serum Ferritin, Week 12 (n = 105) 1109.80  (1016.17)
13.Secondary Outcome
Title Mean Values of Transferrin Over Time
Hide Description Mean values of transferrin were reported.
Time Frame At Weeks -2, 4, 8, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all enrolled participants who received at least one dose of study drug. n = number of participants analyzed at a given time point.
Arm/Group Title Mircera
Hide Arm/Group Description:
Eligible participants were administered methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks.
Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: miligram per mililiter
Transferrin, Week -2 (n = 25) 168.24  (54.07)
Transferrin, Week 4 (n = 16) 160.00  (40.04)
Transferrin, Week 8 (n = 18) 165.72  (40.89)
Transferrin, Week 12 (n = 18) 159.22  (36.04)
14.Secondary Outcome
Title Mean Values of Transferrin Saturation Over Time
Hide Description Mean values of Transferrin Saturation (TSAT) were reported.
Time Frame At Weeks -2, 4, 8, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all enrolled participants who received at least one dose of study drug. n = number of participants analyzed at a given time point.
Arm/Group Title Mircera
Hide Arm/Group Description:
Eligible participants were administered methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks.
Overall Number of Participants Analyzed 125
Mean (Standard Deviation)
Unit of Measure: Percentage
TSAT, Week -2 (n = 125) 45.55  (38.71)
TSAT, Week 4 (n = 116) 48.70  (36.31)
TSAT, Week 8 (n = 109) 46.08  (31.08)
TSAT, Week 12 (n = 106) 45.71  (29.81)
15.Secondary Outcome
Title Mean Values of Serum Albumin and Serum Globulin Over Time
Hide Description Mean values of serum albumin and serum globulin were reported.
Time Frame At Weeks -2, 4, 8, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all enrolled participants who received at least one dose of study drug. n = number of participants analyzed at a given time point.
Arm/Group Title Mircera
Hide Arm/Group Description:
Eligible participants were administered methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks.
Overall Number of Participants Analyzed 132
Mean (Standard Deviation)
Unit of Measure: gram per deciliter
Serum Albumin, Week -2 (n = 132) 3.60  (0.53)
Serum Albumin, Week 4 (n = 123) 3.54  (0.42)
Serum Albumin, Week 8 (n = 118) 3.58  (0.46)
Serum Albumin, Week 12 (n = 115) 3.64  (0.46)
Serum Globulin, Week -2 (n = 131) 3.48  (0.65)
Serum Globulin, Week 4 (n = 123) 3.41  (0.68)
Serum Globulin, Week 8 (n = 117) 3.55  (0.73)
Serum Globulin, Week 12 (n = 113) 3.51  (0.67)
16.Secondary Outcome
Title Mean Values of Aspartate Aminotransferase, Alanine Transaminase and Serum Alkaline Phosphatase Over Time
Hide Description Mean values of aspartate aminotransferase (AST), alanine transaminase (ALT) and serum alkaline phosphatase were reported.
Time Frame At Weeks -2, 4, 8, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all enrolled participants who received at least one dose of study drug. n = number of participants analyzed at a given time point.
Arm/Group Title Mircera
Hide Arm/Group Description:
Eligible participants were administered methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks.
Overall Number of Participants Analyzed 131
Mean (Standard Deviation)
Unit of Measure: units per litre
AST, Week -2 (n = 128) 23.48  (18.45)
AST, Week 4 (n = 123) 23.26  (12.87)
AST, Week 8 (n = 117) 22.86  (15.00)
AST, Week 12 (n = 115) 23.17  (15.69)
ALT, Week -2 (n = 129) 31.34  (27.52)
ALT, Week 4 (n = 121) 30.18  (18.82)
ALT, Week 8 (n = 118) 29.44  (20.26)
ALT, Week 12 (n = 115) 31.07  (20.71)
Serum Alkaline Phosphatase, Week -2 (n = 131) 154.7  (110.6)
Serum Alkaline Phosphatase, Week 4 (n = 123) 163.3  (108.9)
Serum Alkaline Phosphatase, Week 8 (n = 118) 162.1  (123.4)
Serum Alkaline Phosphatase, Week 12 (n = 115) 159.3  (100.1)
17.Secondary Outcome
Title Mean Values of Serum Creatinine, Blood Urea Nitrogen, Serum Phosphate and Serum Bilirubin Over Time
Hide Description Mean values of serum creatinine, blood urea nitrogen (BUN), serum phosphate and serum bilirubin were reported.
Time Frame At Weeks -2, 4, 8, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all enrolled participants who received at least one dose of study drug. n = number of participants analyzed at a given time point.
Arm/Group Title Mircera
Hide Arm/Group Description:
Eligible participants were administered methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks.
Overall Number of Participants Analyzed 132
Mean (Standard Deviation)
Unit of Measure: miligram per deciliter
Serum Creatinine, Week -2 (n = 132) 7.89  (2.96)
Serum Creatinine, Week 4 (n = 123) 8.34  (2.47)
Serum Creatinine, Week 8 (n = 116) 8.03  (2.36)
Serum Creatinine, Week 12 (n = 115) 8.19  (2.72)
BUN, Week -2 (n = 131) 57.72  (29.71)
BUN, Week 4 (n = 122) 60.67  (27.70)
BUN, Week 8 (n = 117) 60.10  (32.04)
BUN, Week 12 (n = 113) 61.79  (35.14)
Serum Phosphate, Week -2 (n = 124) 5.00  (4.70)
Serum Phosphate, Week 4 (n = 114) 5.02  (1.93)
Serum Phosphate, Week 8 (n = 112) 4.81  (1.64)
Serum Phosphate, Week 12 (n = 107) 5.37  (5.22)
Serum Bilirubin, Week -2 (n = 131) 0.52  (0.34)
Serum Bilirubin, Week 4 (n = 123) 0.50  (0.33)
Serum Bilirubin, Week 8 (n = 118) 0.52  (0.43)
Serum Bilirubin, Week 12 (n = 115) 0.51  (0.21)
18.Secondary Outcome
Title Mean Values of Serum Sodium and Serum Potassium Over Time
Hide Description Mean values of serum sodium and serum potassium were reported.
Time Frame At Weeks -2, 4, 8, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all enrolled participants who received at least one dose of study drug. n = number of participants analyzed at a given time point.
Arm/Group Title Mircera
Hide Arm/Group Description:
Eligible participants were administered methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks.
Overall Number of Participants Analyzed 132
Mean (Standard Deviation)
Unit of Measure: millimole per liter
Serum Potassium, Week -2 (n = 132) 5.00  (0.94)
Serum Potassium, Week 4 (n = 123) 6.26  (11.74)
Serum Potassium, Week 8 (n = 118) 5.11  (0.88)
Serum Potassium, Week 12 (n = 115) 5.03  (1.08)
Serum Sodium, Week -2 (n = 132) 137.1  (4.36)
Serum Sodium, Week 4 (n = 122) 136.2  (12.65)
Serum Sodium, Week 8 (n = 118) 137.0  (4.58)
Serum Sodium, Week 12 (n = 115) 136.9  (5.37)
Time Frame Up to Week 14
Adverse Event Reporting Description SAEs and non-serious AEs were reported for the safety population which included all participants who received at least one dose of study medication.
 
Arm/Group Title Mircera
Hide Arm/Group Description Eligible participants with chronic renal anemia were administered methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks.
All-Cause Mortality
Mircera
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Mircera
Affected / at Risk (%)
Total   9/132 (6.82%) 
Cardiac disorders   
Acute myocardial infarction  1  1/132 (0.76%) 
Arrhythmia  1  1/132 (0.76%) 
Gastrointestinal disorders   
Peritonitis  1  1/132 (0.76%) 
General disorders   
Death  1  3/132 (2.27%) 
Pyrexia  1  1/132 (0.76%) 
Musculoskeletal and connective tissue disorders   
Pain in extremity  1  1/132 (0.76%) 
Nervous system disorders   
Coma  1  1/132 (0.76%) 
Convulsion  1  1/132 (0.76%) 
Renal and urinary disorders   
Azotaemia  1  1/132 (0.76%) 
Respiratory, thoracic and mediastinal disorders   
Pulmonary oedema  1  1/132 (0.76%) 
Vascular disorders   
Hypotension  1  1/132 (0.76%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Mircera
Affected / at Risk (%)
Total   36/132 (27.27%) 
Blood and lymphatic system disorders   
Thrombocytopenia  1  2/132 (1.52%) 
Gastrointestinal disorders   
Diarrhoea  1  4/132 (3.03%) 
Vomiting  1  1/132 (0.76%) 
General disorders   
Chills  1  1/132 (0.76%) 
Pyrexia  1  4/132 (3.03%) 
Immune system disorders   
Hypersensitivity  1  1/132 (0.76%) 
Infections and infestations   
Abscess  1  1/132 (0.76%) 
Cellulitis  1  1/132 (0.76%) 
Gastroenteritis  1  1/132 (0.76%) 
Nasopharyngitis  1  1/132 (0.76%) 
Pneumonia  1  1/132 (0.76%) 
Respiratory tract infection  1  1/132 (0.76%) 
Injury, poisoning and procedural complications   
Injury  1  1/132 (0.76%) 
Thermal burn  1  1/132 (0.76%) 
Investigations   
Hepatic enzyme increased  1  1/132 (0.76%) 
Metabolism and nutrition disorders   
Anorexia  1  1/132 (0.76%) 
Fluid overload  1  1/132 (0.76%) 
Hypocalcaemia  1  1/132 (0.76%) 
Musculoskeletal and connective tissue disorders   
Fistula  1  2/132 (1.52%) 
Nervous system disorders   
Headache  1  1/132 (0.76%) 
Renal and urinary disorders   
Renal failure  1  1/132 (0.76%) 
Respiratory, thoracic and mediastinal disorders   
Cough  1  1/132 (0.76%) 
Pulmonary oedema  1  1/132 (0.76%) 
Surgical and medical procedures   
Peritoneal dialysis  1  1/132 (0.76%) 
Vascular disorders   
Hypotension  1  1/132 (0.76%) 
Thrombosis  1  3/132 (2.27%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Roche Trial Information Hotline
Organization: F. Hoffmann-La Roche AG
Phone: +41 616878333
EMail: global.trial_information@roche.com
Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00737464    
Other Study ID Numbers: ML21810
First Submitted: August 18, 2008
First Posted: August 19, 2008
Results First Submitted: February 25, 2016
Results First Posted: April 29, 2016
Last Update Posted: December 7, 2017