Trial Outcomes & Findings for A Study of Intravenous Mircera (C.E.R.A or Methoxy Polyethylene Glycol-epoetin Beta) for the Maintenance Treatment of Hemodialysis Participants With Chronic Renal Anemia (NCT NCT00605293)
NCT ID: NCT00605293
Last Updated: 2016-05-13
Results Overview
Participants who maintained average Hb concentration within +/-1 g/dL of their reference Hb and between 10 to 12 g/dL during EEP are reported. The reference Hb value was defined on the basis of all assessments at Weeks -4, -3, -2, -1 and 0.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
101 participants
Primary outcome timeframe
EEP (Week 16 to 23)
Results posted on
2016-05-13
Participant Flow
Participant milestones
| Measure |
C.E.R.A
Participants received starting dose of 120, 200 or 360 micrograms (mcg) of C.E.R.A intravenously (IV) once monthly for 6 months. The starting dose was based on the dose of epoetin alfa administered in Week -1.
|
Epoetin Alfa
Participants received IV injection of 6000 International Units (IU) of epoetin alfa every 3 weeks (q3wk) during the Stability Verification Period (SVP; Week -4 to -1), 7443 IU of epoetin alfa q3wk during Dose Titration Period (DTP; Week 0 to 15), and 7363 IU of epoetin alfa q3wk during Efficacy Evaluation Period (EEP; Week 16 to 23) up to 23 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
65
|
36
|
|
Overall Study
COMPLETED
|
48
|
31
|
|
Overall Study
NOT COMPLETED
|
17
|
5
|
Reasons for withdrawal
| Measure |
C.E.R.A
Participants received starting dose of 120, 200 or 360 micrograms (mcg) of C.E.R.A intravenously (IV) once monthly for 6 months. The starting dose was based on the dose of epoetin alfa administered in Week -1.
|
Epoetin Alfa
Participants received IV injection of 6000 International Units (IU) of epoetin alfa every 3 weeks (q3wk) during the Stability Verification Period (SVP; Week -4 to -1), 7443 IU of epoetin alfa q3wk during Dose Titration Period (DTP; Week 0 to 15), and 7363 IU of epoetin alfa q3wk during Efficacy Evaluation Period (EEP; Week 16 to 23) up to 23 weeks.
|
|---|---|---|
|
Overall Study
Death
|
2
|
1
|
|
Overall Study
Insufficient Therapeutic Response
|
2
|
0
|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Holidays Dialysis Out
|
1
|
0
|
|
Overall Study
Blood Transfusion
|
7
|
1
|
|
Overall Study
Renal Transplantation
|
3
|
1
|
|
Overall Study
Incorrect Epoetin Beta Administration
|
1
|
0
|
|
Overall Study
Dialysis Out of Centre for 3 Months
|
0
|
1
|
|
Overall Study
Principal Investigator Decision
|
0
|
1
|
Baseline Characteristics
A Study of Intravenous Mircera (C.E.R.A or Methoxy Polyethylene Glycol-epoetin Beta) for the Maintenance Treatment of Hemodialysis Participants With Chronic Renal Anemia
Baseline characteristics by cohort
| Measure |
C.E.R.A
n=65 Participants
Participants received starting dose of 120, 200 or 360 mcg of C.E.R.A IV once monthly for 6 months. The starting dose was based on the dose of epoetin alfa administered in Week -1.
|
Epoetin Alfa
n=36 Participants
Participants received IV injection of 6000 IU of epoetin alfa q3wk during the SVP (Week -4 to -1), 7443 IU of epoetin alfa q3wk during DTP (Week 0 to 15), and 7363 IU of epoetin alfa q3wk during EEP (Week 16 to 23) up to 23 weeks.
|
Total
n=101 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.2 years
STANDARD_DEVIATION 14.93 • n=5 Participants
|
64.5 years
STANDARD_DEVIATION 16.62 • n=7 Participants
|
64.9 years
STANDARD_DEVIATION 15.47 • n=5 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: EEP (Week 16 to 23)Population: Per Protocol (PP) population was as a subset of the ITT population who completed the study without any major protocol deviations.
Participants who maintained average Hb concentration within +/-1 g/dL of their reference Hb and between 10 to 12 g/dL during EEP are reported. The reference Hb value was defined on the basis of all assessments at Weeks -4, -3, -2, -1 and 0.
Outcome measures
| Measure |
C.E.R.A
n=44 Participants
Participants received starting dose of 120, 200 or 360 mcg of C.E.R.A IV once monthly for 6 months. The starting dose was based on the dose of epoetin alfa administered in Week -1.
|
Epoetin Alfa
n=29 Participants
Participants received IV injection of 6000 IU of epoetin alfa q3wk during the SVP (Week -4 to -1), 7443 IU of epoetin alfa q3wk during DTP (Week 0 to 15), and 7363 IU of epoetin alfa q3wk during EEP (Week 16 to 23) up to 23 weeks.
|
|---|---|---|
|
Percentage of Participants Who Maintained Average Hemoglobin (Hb) Concentration Within Plus Minus (+/-) 1 Grams Per Deciliter (g/dL) of Their Reference Hb and Between 10 and 12 g/dL During the EEP
|
45.45 percentage of participants
Interval 30.39 to 61.15
|
55.17 percentage of participants
Interval 35.69 to 73.55
|
SECONDARY outcome
Timeframe: SVP (Week -4 to -1), EEP (Week 16 to 23)Population: ITT population.
Change in Hb concentration between baseline SVP and the EEP was evaluated by subtracting the mean of Hb concentration during the SVP (Weeks -4 to -1) with the mean of Hb concentration during the EEP (Weeks 16 to 23).
Outcome measures
| Measure |
C.E.R.A
n=65 Participants
Participants received starting dose of 120, 200 or 360 mcg of C.E.R.A IV once monthly for 6 months. The starting dose was based on the dose of epoetin alfa administered in Week -1.
|
Epoetin Alfa
n=36 Participants
Participants received IV injection of 6000 IU of epoetin alfa q3wk during the SVP (Week -4 to -1), 7443 IU of epoetin alfa q3wk during DTP (Week 0 to 15), and 7363 IU of epoetin alfa q3wk during EEP (Week 16 to 23) up to 23 weeks.
|
|---|---|---|
|
Change in Hb Concentrations Between Baseline SVP and the EEP
|
-0.35 g/dL
Standard Deviation 1.32
|
0.32 g/dL
Standard Deviation 1.06
|
SECONDARY outcome
Timeframe: EEP (Week 16 to 23)Population: ITT population
Participants who maintained Hb concentration between 10 to 12 g/dL throughout the EEP are reported.
Outcome measures
| Measure |
C.E.R.A
n=65 Participants
Participants received starting dose of 120, 200 or 360 mcg of C.E.R.A IV once monthly for 6 months. The starting dose was based on the dose of epoetin alfa administered in Week -1.
|
Epoetin Alfa
n=36 Participants
Participants received IV injection of 6000 IU of epoetin alfa q3wk during the SVP (Week -4 to -1), 7443 IU of epoetin alfa q3wk during DTP (Week 0 to 15), and 7363 IU of epoetin alfa q3wk during EEP (Week 16 to 23) up to 23 weeks.
|
|---|---|---|
|
Percentage of Participants Who Maintained Hb Concentration Between 10 and 12 g/dL Throughout the EEP
|
32.7 percentage of participants
|
40.6 percentage of participants
|
SECONDARY outcome
Timeframe: SVP (Week -4 to -1), DTP (Week 0 to 15), and EEP (Week 16 to 23)Population: ITT population. Here, n = participants who were evaluable for each category, for respective arm groups.
Outcome measures
| Measure |
C.E.R.A
n=65 Participants
Participants received starting dose of 120, 200 or 360 mcg of C.E.R.A IV once monthly for 6 months. The starting dose was based on the dose of epoetin alfa administered in Week -1.
|
Epoetin Alfa
n=36 Participants
Participants received IV injection of 6000 IU of epoetin alfa q3wk during the SVP (Week -4 to -1), 7443 IU of epoetin alfa q3wk during DTP (Week 0 to 15), and 7363 IU of epoetin alfa q3wk during EEP (Week 16 to 23) up to 23 weeks.
|
|---|---|---|
|
Mean Time Spent in Hb Range 10-12 g/dL
SVP (Week -4 to -1) (n=65, 36)
|
26.7 days
Standard Deviation 4.46
|
27.1 days
Standard Deviation 4.74
|
|
Mean Time Spent in Hb Range 10-12 g/dL
DTP (Week 0 to 15) (n=65, 36)
|
67.5 days
Standard Deviation 33.92
|
72.9 days
Standard Deviation 37.03
|
|
Mean Time Spent in Hb Range 10-12 g/dL
EEP (Week 16 to 23) (n=55, 32)
|
32.2 days
Standard Deviation 18.25
|
28.9 days
Standard Deviation 21.53
|
SECONDARY outcome
Timeframe: DTP (Week 0 to 15) and EEP (Week 16 to 23)Population: Safety population included all those participants who were treated with at least one dose of the trial medication and had a safety follow-up, whether withdrawn prematurely or not. Here, "n" = participants who were evaluable for each category, for respective arm groups.
Outcome measures
| Measure |
C.E.R.A
n=65 Participants
Participants received starting dose of 120, 200 or 360 mcg of C.E.R.A IV once monthly for 6 months. The starting dose was based on the dose of epoetin alfa administered in Week -1.
|
Epoetin Alfa
n=36 Participants
Participants received IV injection of 6000 IU of epoetin alfa q3wk during the SVP (Week -4 to -1), 7443 IU of epoetin alfa q3wk during DTP (Week 0 to 15), and 7363 IU of epoetin alfa q3wk during EEP (Week 16 to 23) up to 23 weeks.
|
|---|---|---|
|
Percentage of Participants Who Required Dose Adjustments During the DTP and EEP
DTP:Only one dose changed (n=65,36)
|
1.5 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants Who Required Dose Adjustments During the DTP and EEP
DTP: No dose change (n=65, 36)
|
30.8 percentage of participants
|
44.4 percentage of participants
|
|
Percentage of Participants Who Required Dose Adjustments During the DTP and EEP
DTP: Any dose change (n=65, 36)
|
67.7 percentage of participants
|
55.6 percentage of participants
|
|
Percentage of Participants Who Required Dose Adjustments During the DTP and EEP
DTP: Dose increased (n=65, 36)
|
18.5 percentage of participants
|
19.4 percentage of participants
|
|
Percentage of Participants Who Required Dose Adjustments During the DTP and EEP
DTP: Dose decreased (n=65, 36)
|
24.6 percentage of participants
|
25.0 percentage of participants
|
|
Percentage of Participants Who Required Dose Adjustments During the DTP and EEP
DTP: Dose decreased and increased (n=65, 36)
|
24.6 percentage of participants
|
11.1 percentage of participants
|
|
Percentage of Participants Who Required Dose Adjustments During the DTP and EEP
EEP: No dose change (n=55, 32)
|
60.0 percentage of participants
|
65.6 percentage of participants
|
|
Percentage of Participants Who Required Dose Adjustments During the DTP and EEP
EEP: Any dose change (n=55, 32)
|
30.9 percentage of participants
|
34.4 percentage of participants
|
|
Percentage of Participants Who Required Dose Adjustments During the DTP and EEP
EEP: Dose increased (n=55, 32)
|
20.0 percentage of participants
|
12.5 percentage of participants
|
|
Percentage of Participants Who Required Dose Adjustments During the DTP and EEP
EEP: Dose decreased (n=55, 32)
|
10.9 percentage of participants
|
18.8 percentage of participants
|
|
Percentage of Participants Who Required Dose Adjustments During the DTP and EEP
EEP: Dose decreased and increased (n=55, 32)
|
0.0 percentage of participants
|
3.1 percentage of participants
|
|
Percentage of Participants Who Required Dose Adjustments During the DTP and EEP
EEP: Only one dose changed (n=55, 32)
|
9.1 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: DTP (Week 0 to 15) up to EEP (Week 16 to 23)Population: ITT population
RBC transfusions could be given during the study in case of medical need, i.e., in severely anemic participants with recognized symptoms or signs of anemia (e.g., in participants with acute blood loss, with severe angina, or whose hemoglobin decreased to critical levels).
Outcome measures
| Measure |
C.E.R.A
n=65 Participants
Participants received starting dose of 120, 200 or 360 mcg of C.E.R.A IV once monthly for 6 months. The starting dose was based on the dose of epoetin alfa administered in Week -1.
|
Epoetin Alfa
n=36 Participants
Participants received IV injection of 6000 IU of epoetin alfa q3wk during the SVP (Week -4 to -1), 7443 IU of epoetin alfa q3wk during DTP (Week 0 to 15), and 7363 IU of epoetin alfa q3wk during EEP (Week 16 to 23) up to 23 weeks.
|
|---|---|---|
|
Percentage of Participants Who Received Red Blood Cell (RBC) Transfusions During DTP and EEP
|
12.3 percentage of participants
|
2.8 percentage of participants
|
Adverse Events
C.E.R.A
Serious events: 16 serious events
Other events: 11 other events
Deaths: 0 deaths
Epoetin Alfa
Serious events: 4 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
C.E.R.A
n=65 participants at risk
Participants received starting dose of 120, 200 or 360 mcg of C.E.R.A IV once monthly for 6 months. The starting dose was based on the dose of epoetin alfa administered in Week -1.
|
Epoetin Alfa
n=36 participants at risk
Participants received IV injection of 6000 IU of epoetin alfa q3wk during the SVP (Week -4 to -1), 7443 IU of epoetin alfa q3wk during DTP (Week 0 to 15), and 7363 IU of epoetin alfa q3wk during EEP (Week 16 to 23) up to 23 weeks.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.5%
1/65 • Week 0 to Week 28
|
0.00%
0/36 • Week 0 to Week 28
|
|
Cardiac disorders
Acute myocardial infarction
|
1.5%
1/65 • Week 0 to Week 28
|
0.00%
0/36 • Week 0 to Week 28
|
|
Cardiac disorders
Angina pectoris
|
1.5%
1/65 • Week 0 to Week 28
|
0.00%
0/36 • Week 0 to Week 28
|
|
Cardiac disorders
Cardiac arrest
|
1.5%
1/65 • Week 0 to Week 28
|
0.00%
0/36 • Week 0 to Week 28
|
|
Cardiac disorders
Cardiac failure congestive
|
1.5%
1/65 • Week 0 to Week 28
|
0.00%
0/36 • Week 0 to Week 28
|
|
Cardiac disorders
Myocardial infarction
|
1.5%
1/65 • Week 0 to Week 28
|
0.00%
0/36 • Week 0 to Week 28
|
|
Gastrointestinal disorders
Intestinal obstruction
|
1.5%
1/65 • Week 0 to Week 28
|
0.00%
0/36 • Week 0 to Week 28
|
|
General disorders
Death
|
0.00%
0/65 • Week 0 to Week 28
|
2.8%
1/36 • Week 0 to Week 28
|
|
General disorders
Pyrexia
|
1.5%
1/65 • Week 0 to Week 28
|
0.00%
0/36 • Week 0 to Week 28
|
|
Hepatobiliary disorders
Cholecystitis acute
|
1.5%
1/65 • Week 0 to Week 28
|
0.00%
0/36 • Week 0 to Week 28
|
|
Infections and infestations
Bronchiectasis
|
1.5%
1/65 • Week 0 to Week 28
|
0.00%
0/36 • Week 0 to Week 28
|
|
Infections and infestations
Cellulitis
|
1.5%
1/65 • Week 0 to Week 28
|
0.00%
0/36 • Week 0 to Week 28
|
|
Infections and infestations
Lung infection pseudomonal
|
1.5%
1/65 • Week 0 to Week 28
|
0.00%
0/36 • Week 0 to Week 28
|
|
Infections and infestations
Pneumonia
|
3.1%
2/65 • Week 0 to Week 28
|
0.00%
0/36 • Week 0 to Week 28
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/65 • Week 0 to Week 28
|
2.8%
1/36 • Week 0 to Week 28
|
|
Infections and infestations
Respiratory tract infection
|
1.5%
1/65 • Week 0 to Week 28
|
2.8%
1/36 • Week 0 to Week 28
|
|
Infections and infestations
Sepsis
|
1.5%
1/65 • Week 0 to Week 28
|
0.00%
0/36 • Week 0 to Week 28
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/65 • Week 0 to Week 28
|
2.8%
1/36 • Week 0 to Week 28
|
|
Injury, poisoning and procedural complications
Hip fracture
|
1.5%
1/65 • Week 0 to Week 28
|
0.00%
0/36 • Week 0 to Week 28
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.5%
1/65 • Week 0 to Week 28
|
0.00%
0/36 • Week 0 to Week 28
|
|
Nervous system disorders
Ischaemic neuropathy
|
1.5%
1/65 • Week 0 to Week 28
|
0.00%
0/36 • Week 0 to Week 28
|
|
Psychiatric disorders
Confusional state
|
1.5%
1/65 • Week 0 to Week 28
|
0.00%
0/36 • Week 0 to Week 28
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
1.5%
1/65 • Week 0 to Week 28
|
0.00%
0/36 • Week 0 to Week 28
|
|
Vascular disorders
Peripheral ischaemia
|
1.5%
1/65 • Week 0 to Week 28
|
0.00%
0/36 • Week 0 to Week 28
|
|
Vascular disorders
Shock
|
1.5%
1/65 • Week 0 to Week 28
|
0.00%
0/36 • Week 0 to Week 28
|
Other adverse events
| Measure |
C.E.R.A
n=65 participants at risk
Participants received starting dose of 120, 200 or 360 mcg of C.E.R.A IV once monthly for 6 months. The starting dose was based on the dose of epoetin alfa administered in Week -1.
|
Epoetin Alfa
n=36 participants at risk
Participants received IV injection of 6000 IU of epoetin alfa q3wk during the SVP (Week -4 to -1), 7443 IU of epoetin alfa q3wk during DTP (Week 0 to 15), and 7363 IU of epoetin alfa q3wk during EEP (Week 16 to 23) up to 23 weeks.
|
|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
7.7%
5/65 • Week 0 to Week 28
|
0.00%
0/36 • Week 0 to Week 28
|
|
Infections and infestations
Nasopharyngitis
|
1.5%
1/65 • Week 0 to Week 28
|
5.6%
2/36 • Week 0 to Week 28
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/65 • Week 0 to Week 28
|
5.6%
2/36 • Week 0 to Week 28
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
0.00%
0/65 • Week 0 to Week 28
|
5.6%
2/36 • Week 0 to Week 28
|
|
Vascular disorders
Hypertension
|
9.2%
6/65 • Week 0 to Week 28
|
11.1%
4/36 • Week 0 to Week 28
|
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