Trial Outcomes & Findings for An Observational Study of Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) in Stage III-IV Chronic Kidney Disease Patients Not on Dialysis With Renal Anemia (NCT NCT01695746)
NCT ID: NCT01695746
Last Updated: 2016-06-02
Results Overview
The mean body height of the participants was measured and summarized in centimeters (cm). Baseline is defined as Week 0.
COMPLETED
108 participants
At Baseline (Week 0)
2016-06-02
Participant Flow
A total of 108 participants were enrolled in this study conducted from 30 August 2011 to 13 November 2013 at 6 sites in India.
Participant milestones
| Measure |
C.E.R.A.
Participants with chronic renal anemia Stage III-IV, not on dialysis, were administered C.E.R.A. according to routine clinical practice and were followed for the treatment duration of 24 weeks (6 months). Dosing and titration of C.E.R.A. treatment was at the discretion of the investigator in accordance with local clinical practice or prescribing information. Dosing instructions as per the local label were - For correction of anemia: 0.6 mcg/kg of C.E.R.A. once every two weeks, and for Maintenance of Hb levels: Conversion to C.E.R.A. dose (120, 200, or 360 mcg either once monthly; or 60, 100, or 180 mcg once every 2 weeks) depending on the previous weekly epoetin or darbepoetin dose.
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|---|---|
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Overall Study
STARTED
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108
|
|
Overall Study
COMPLETED
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96
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Overall Study
NOT COMPLETED
|
12
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Reasons for withdrawal
| Measure |
C.E.R.A.
Participants with chronic renal anemia Stage III-IV, not on dialysis, were administered C.E.R.A. according to routine clinical practice and were followed for the treatment duration of 24 weeks (6 months). Dosing and titration of C.E.R.A. treatment was at the discretion of the investigator in accordance with local clinical practice or prescribing information. Dosing instructions as per the local label were - For correction of anemia: 0.6 mcg/kg of C.E.R.A. once every two weeks, and for Maintenance of Hb levels: Conversion to C.E.R.A. dose (120, 200, or 360 mcg either once monthly; or 60, 100, or 180 mcg once every 2 weeks) depending on the previous weekly epoetin or darbepoetin dose.
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|---|---|
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Overall Study
Adverse Event
|
1
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Overall Study
Non-compliance by the participant
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3
|
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Overall Study
Protocol Violation
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5
|
|
Overall Study
Participant not willing to participate
|
3
|
Baseline Characteristics
An Observational Study of Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) in Stage III-IV Chronic Kidney Disease Patients Not on Dialysis With Renal Anemia
Baseline characteristics by cohort
| Measure |
C.E.R.A.
n=108 Participants
Participants with chronic renal anemia Stage III-IV, not on dialysis, were administered C.E.R.A. according to routine clinical practice and were followed for the treatment duration of 24 weeks (6 months). Dosing and titration of C.E.R.A. treatment was at the discretion of the investigator in accordance with local clinical practice or prescribing information. Dosing instructions as per the local label were - For correction of anemia: 0.6 mcg/kg of C.E.R.A. once every two weeks, and for Maintenance of Hb levels: Conversion to C.E.R.A. dose (120, 200, or 360 mcg either once monthly; or 60, 100, or 180 mcg once every 2 weeks) depending on the previous weekly epoetin or darbepoetin dose.
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|---|---|
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Age, Continuous
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55.5 years
STANDARD_DEVIATION 7.178 • n=5 Participants
|
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Sex: Female, Male
Female
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36 Participants
n=5 Participants
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Sex: Female, Male
Male
|
72 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At Baseline (Week 0)Population: The safety population included all participants entered into the study.
The mean body height of the participants was measured and summarized in centimeters (cm). Baseline is defined as Week 0.
Outcome measures
| Measure |
C.E.R.A.
n=108 Participants
Participants with chronic renal anemia Stage III-IV, not on dialysis, were administered C.E.R.A. according to routine clinical practice and were followed for the treatment duration of 24 weeks (6 months). Dosing and titration of C.E.R.A. treatment was at the discretion of the investigator in accordance with local clinical practice or prescribing information. Dosing instructions as per the local label were - For correction of anemia: 0.6 mcg/kg of C.E.R.A. once every two weeks, and for Maintenance of Hb levels: Conversion to C.E.R.A. dose (120, 200, or 360 mcg either once monthly; or 60, 100, or 180 mcg once every 2 weeks) depending on the previous weekly epoetin or darbepoetin dose.
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|---|---|
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Mean Height of Participants at Baseline (Week 0)
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163.15 cm
Standard Deviation 7.366
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PRIMARY outcome
Timeframe: At Baseline (Week 0)Population: The safety population included all participants entered into the study.
The mean body weight of the participants was measured and summarized in kg. Baseline is defined as Week 0.
Outcome measures
| Measure |
C.E.R.A.
n=108 Participants
Participants with chronic renal anemia Stage III-IV, not on dialysis, were administered C.E.R.A. according to routine clinical practice and were followed for the treatment duration of 24 weeks (6 months). Dosing and titration of C.E.R.A. treatment was at the discretion of the investigator in accordance with local clinical practice or prescribing information. Dosing instructions as per the local label were - For correction of anemia: 0.6 mcg/kg of C.E.R.A. once every two weeks, and for Maintenance of Hb levels: Conversion to C.E.R.A. dose (120, 200, or 360 mcg either once monthly; or 60, 100, or 180 mcg once every 2 weeks) depending on the previous weekly epoetin or darbepoetin dose.
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|---|---|
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Mean Weight of Participants at Baseline (Week 0)
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60.23 kg
Standard Deviation 9.618
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PRIMARY outcome
Timeframe: At Baseline (Week 0)Population: The safety population included all participants entered into the study.
Co-morbidities were those medical disorders present in the medical history but unresolved at Baseline. The number of participants with different co-morbidities is presented. Baseline is defined as Week 0.
Outcome measures
| Measure |
C.E.R.A.
n=108 Participants
Participants with chronic renal anemia Stage III-IV, not on dialysis, were administered C.E.R.A. according to routine clinical practice and were followed for the treatment duration of 24 weeks (6 months). Dosing and titration of C.E.R.A. treatment was at the discretion of the investigator in accordance with local clinical practice or prescribing information. Dosing instructions as per the local label were - For correction of anemia: 0.6 mcg/kg of C.E.R.A. once every two weeks, and for Maintenance of Hb levels: Conversion to C.E.R.A. dose (120, 200, or 360 mcg either once monthly; or 60, 100, or 180 mcg once every 2 weeks) depending on the previous weekly epoetin or darbepoetin dose.
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|---|---|
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Number of Participants With Co-morbidities at Baseline (Week 0)
Glomerulonephritis
|
2 Participants
|
|
Number of Participants With Co-morbidities at Baseline (Week 0)
Nephrolithiasis
|
2 Participants
|
|
Number of Participants With Co-morbidities at Baseline (Week 0)
Anaemia
|
2 Participants
|
|
Number of Participants With Co-morbidities at Baseline (Week 0)
Myocardial ischaemia
|
4 Participants
|
|
Number of Participants With Co-morbidities at Baseline (Week 0)
Congenital cystic kidney disease
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1 Participants
|
|
Number of Participants With Co-morbidities at Baseline (Week 0)
Renal hypoplasia
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1 Participants
|
|
Number of Participants With Co-morbidities at Baseline (Week 0)
Hypothyroidism
|
4 Participants
|
|
Number of Participants With Co-morbidities at Baseline (Week 0)
Liver disorder
|
1 Participants
|
|
Number of Participants With Co-morbidities at Baseline (Week 0)
Diabetes mellitus
|
18 Participants
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|
Number of Participants With Co-morbidities at Baseline (Week 0)
Dyslipidaemia
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1 Participants
|
|
Number of Participants With Co-morbidities at Baseline (Week 0)
Type 1 diabetes mellitus
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1 Participants
|
|
Number of Participants With Co-morbidities at Baseline (Week 0)
Type 2 diabetes mellitus
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66 Participants
|
|
Number of Participants With Co-morbidities at Baseline (Week 0)
Osteoarthritis
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2 Participants
|
|
Number of Participants With Co-morbidities at Baseline (Week 0)
Osteoporosis
|
1 Participants
|
|
Number of Participants With Co-morbidities at Baseline (Week 0)
Rheumatoid arthritis
|
1 Participants
|
|
Number of Participants With Co-morbidities at Baseline (Week 0)
Systemic lupus erythematosus
|
1 Participants
|
|
Number of Participants With Co-morbidities at Baseline (Week 0)
Nephropathy
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1 Participants
|
|
Number of Participants With Co-morbidities at Baseline (Week 0)
Renal failure chronic
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28 Participants
|
|
Number of Participants With Co-morbidities at Baseline (Week 0)
Tubulointerstitial nephritis
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1 Participants
|
|
Number of Participants With Co-morbidities at Baseline (Week 0)
Asthma
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1 Participants
|
|
Number of Participants With Co-morbidities at Baseline (Week 0)
Chronic obstructive pulmonary disorders
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1 Participants
|
|
Number of Participants With Co-morbidities at Baseline (Week 0)
Coronary angioplasty
|
1 Participants
|
|
Number of Participants With Co-morbidities at Baseline (Week 0)
Renal transplant
|
1 Participants
|
|
Number of Participants With Co-morbidities at Baseline (Week 0)
Hypertension
|
90 Participants
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PRIMARY outcome
Timeframe: Up to Week 24Population: The intent-to-treat (ITT) population included all participants who received at least 1 dose of C.E.R.A. (Week 0), for whom data for at least one follow-up variable was available, and who did not have a major protocol violation. The participants who achieved target Hb range (10-12 g/dL) were included in the analysis.
Correction of anemia was evaluated in participants with Hb \< 10 gram/deciliter (g/dL). Hemoglobin levels were recorded for each participant at enrollment and at different time points during the study up to Week 24. The mean time required to achieve target Hb range (10-12 g/dL) was calculated using the following formula: Time to achieve target range = (Date of Hb evaluation when participant achieves target range at first time - visit date of first dosing) + 1.
Outcome measures
| Measure |
C.E.R.A.
n=83 Participants
Participants with chronic renal anemia Stage III-IV, not on dialysis, were administered C.E.R.A. according to routine clinical practice and were followed for the treatment duration of 24 weeks (6 months). Dosing and titration of C.E.R.A. treatment was at the discretion of the investigator in accordance with local clinical practice or prescribing information. Dosing instructions as per the local label were - For correction of anemia: 0.6 mcg/kg of C.E.R.A. once every two weeks, and for Maintenance of Hb levels: Conversion to C.E.R.A. dose (120, 200, or 360 mcg either once monthly; or 60, 100, or 180 mcg once every 2 weeks) depending on the previous weekly epoetin or darbepoetin dose.
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|---|---|
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Mean Time to Achieve Target Hemoglobin Range (10-12 Gram/Deciliter)
|
9.61 Weeks
Standard Deviation 6.130
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PRIMARY outcome
Timeframe: Up to Week 24Population: The ITT population was the anticipated population for analysis.
Maintenance of Hb levels was to be evaluated for participants on Erythropoiesis stimulating agent (ESA) with Hb levels 10-12 g/dL. None of the participants in the enrolled population had received treatment with other ESAs and had pre-therapy Hb level as 10 g/dL or above. Therefore, the percentage of participants who had received treatment with other ESAs and were maintaining Hb level within 1 g/dL of baseline value during the study could not be evaluated. Baseline is defined as Week 0.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to Week 24Population: The ITT population included all participants who received at least 1 dose of C.E.R.A. (Week 0), for whom data for at least one follow-up variable was available, and who did not have a major protocol violation.
Correction of anemia was evaluated in participants with Hb \< 10 g/dL at enrollment. Hemoglobin levels were recorded for each participant at enrollment and at different time points during the study up to Week 24. The percentage of participants achieving the target Hb range (10-12 g/dL) at least once during the study is presented.
Outcome measures
| Measure |
C.E.R.A.
n=92 Participants
Participants with chronic renal anemia Stage III-IV, not on dialysis, were administered C.E.R.A. according to routine clinical practice and were followed for the treatment duration of 24 weeks (6 months). Dosing and titration of C.E.R.A. treatment was at the discretion of the investigator in accordance with local clinical practice or prescribing information. Dosing instructions as per the local label were - For correction of anemia: 0.6 mcg/kg of C.E.R.A. once every two weeks, and for Maintenance of Hb levels: Conversion to C.E.R.A. dose (120, 200, or 360 mcg either once monthly; or 60, 100, or 180 mcg once every 2 weeks) depending on the previous weekly epoetin or darbepoetin dose.
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|---|---|
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Percentage of Participants Achieving Hemoglobin Target Range (10-12 Gram/Deciliter) at Least Once During the Study
|
90.2 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to Week 24Population: The ITT population included all participants who received at least 1 dose of C.E.R.A. (Week 0), for whom data for at least one follow-up variable was available, and who did not have a major protocol violation. The participants who achieved target Hb range (10-12 g/dL) were included in the analysis.
The Hb concentration was recorded for all the participants at enrollment and different time points throughout the study up to Week 24. The mean time spent (in weeks) by the participants in the target range (10 - 12 g/dL) is presented.
Outcome measures
| Measure |
C.E.R.A.
n=72 Participants
Participants with chronic renal anemia Stage III-IV, not on dialysis, were administered C.E.R.A. according to routine clinical practice and were followed for the treatment duration of 24 weeks (6 months). Dosing and titration of C.E.R.A. treatment was at the discretion of the investigator in accordance with local clinical practice or prescribing information. Dosing instructions as per the local label were - For correction of anemia: 0.6 mcg/kg of C.E.R.A. once every two weeks, and for Maintenance of Hb levels: Conversion to C.E.R.A. dose (120, 200, or 360 mcg either once monthly; or 60, 100, or 180 mcg once every 2 weeks) depending on the previous weekly epoetin or darbepoetin dose.
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|---|---|
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Mean Time Spent in the Hemoglobin Target Range (10 - 12 Gram/Deciliter)
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16.69 Weeks
Standard Deviation 4.124
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SECONDARY outcome
Timeframe: Up to Week 24Population: The safety population included all participants entered into the study.
The mean dose of C.E.R.A. administered during the study is reported. This accounts for the study drug injected through subcutaneous route at a frequency of every 4 weeks or once a month and every 2 weeks or fortnightly.
Outcome measures
| Measure |
C.E.R.A.
n=108 Participants
Participants with chronic renal anemia Stage III-IV, not on dialysis, were administered C.E.R.A. according to routine clinical practice and were followed for the treatment duration of 24 weeks (6 months). Dosing and titration of C.E.R.A. treatment was at the discretion of the investigator in accordance with local clinical practice or prescribing information. Dosing instructions as per the local label were - For correction of anemia: 0.6 mcg/kg of C.E.R.A. once every two weeks, and for Maintenance of Hb levels: Conversion to C.E.R.A. dose (120, 200, or 360 mcg either once monthly; or 60, 100, or 180 mcg once every 2 weeks) depending on the previous weekly epoetin or darbepoetin dose.
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|---|---|
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Mean Dose of C.E.R.A. Administered
|
75.5 mcg per month
Standard Deviation 26.79
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SECONDARY outcome
Timeframe: Up to Week 24Population: The safety population included all participants entered into the study.
The number of doses of C.E.R.A. administered by the intravenous or subcutaneous route is presented. The number of doses for total population is calculated by summation and presented in table below as per routes of administration.
Outcome measures
| Measure |
C.E.R.A.
n=108 Participants
Participants with chronic renal anemia Stage III-IV, not on dialysis, were administered C.E.R.A. according to routine clinical practice and were followed for the treatment duration of 24 weeks (6 months). Dosing and titration of C.E.R.A. treatment was at the discretion of the investigator in accordance with local clinical practice or prescribing information. Dosing instructions as per the local label were - For correction of anemia: 0.6 mcg/kg of C.E.R.A. once every two weeks, and for Maintenance of Hb levels: Conversion to C.E.R.A. dose (120, 200, or 360 mcg either once monthly; or 60, 100, or 180 mcg once every 2 weeks) depending on the previous weekly epoetin or darbepoetin dose.
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|---|---|
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Number of Doses of C.E.R.A. Administered by Different Routes
Intravenous route
|
0 Doses
|
|
Number of Doses of C.E.R.A. Administered by Different Routes
Subcutaneous route
|
572 Doses
|
SECONDARY outcome
Timeframe: Up to Week 24Population: The safety population included all participants entered into the study.
Medications that were used during the study treatment period (from the date of first dose of study medication to the end of the study) were included as concomitant medications. The number of participants taking concomitant medications prescribed for the treatment of anemia (for example iron) is presented.
Outcome measures
| Measure |
C.E.R.A.
n=108 Participants
Participants with chronic renal anemia Stage III-IV, not on dialysis, were administered C.E.R.A. according to routine clinical practice and were followed for the treatment duration of 24 weeks (6 months). Dosing and titration of C.E.R.A. treatment was at the discretion of the investigator in accordance with local clinical practice or prescribing information. Dosing instructions as per the local label were - For correction of anemia: 0.6 mcg/kg of C.E.R.A. once every two weeks, and for Maintenance of Hb levels: Conversion to C.E.R.A. dose (120, 200, or 360 mcg either once monthly; or 60, 100, or 180 mcg once every 2 weeks) depending on the previous weekly epoetin or darbepoetin dose.
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|---|---|
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Number of Participants Who Received Concomitant Treatment for Anemia
Multivitamin
|
17 Participants
|
|
Number of Participants Who Received Concomitant Treatment for Anemia
Iron supplement
|
15 Participants
|
|
Number of Participants Who Received Concomitant Treatment for Anemia
Vitamin B
|
15 Participants
|
|
Number of Participants Who Received Concomitant Treatment for Anemia
Iron + multivitamin
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to Week 24Population: The safety population was defined as all participants entered into the study.
An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Pre-existing conditions which worsened during this study were reported as AEs. A serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.
Outcome measures
| Measure |
C.E.R.A.
n=108 Participants
Participants with chronic renal anemia Stage III-IV, not on dialysis, were administered C.E.R.A. according to routine clinical practice and were followed for the treatment duration of 24 weeks (6 months). Dosing and titration of C.E.R.A. treatment was at the discretion of the investigator in accordance with local clinical practice or prescribing information. Dosing instructions as per the local label were - For correction of anemia: 0.6 mcg/kg of C.E.R.A. once every two weeks, and for Maintenance of Hb levels: Conversion to C.E.R.A. dose (120, 200, or 360 mcg either once monthly; or 60, 100, or 180 mcg once every 2 weeks) depending on the previous weekly epoetin or darbepoetin dose.
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|---|---|
|
Number of Participants With Adverse Events and Serious Adverse Events
Number of participants with any AE
|
4 Participants
|
|
Number of Participants With Adverse Events and Serious Adverse Events
Number of participants with any SAE
|
2 Participants
|
Adverse Events
C.E.R.A.
Serious adverse events
| Measure |
C.E.R.A.
n=108 participants at risk
Participants with chronic renal anemia Stage III-IV, not on dialysis, were administered C.E.R.A. according to routine clinical practice and were followed for the treatment duration of 24 weeks (6 months). Dosing and titration of C.E.R.A. treatment was at the discretion of the investigator in accordance with local clinical practice or prescribing information. Dosing instructions as per the local label were - For correction of anemia: 0.6 mcg/kg of C.E.R.A. once every two weeks, and for Maintenance of Hb levels: Conversion to C.E.R.A. dose (120, 200, or 360 mcg either once monthly; or 60, 100, or 180 mcg once every 2 weeks) depending on the previous weekly epoetin or darbepoetin dose.
|
|---|---|
|
Gastrointestinal disorders
Pancreatitis
|
0.93%
1/108 • Up to Week 24
Adverse event data was reported for the safety population which included all participants entered into the study.
|
|
Infections and infestations
Device related infection
|
0.93%
1/108 • Up to Week 24
Adverse event data was reported for the safety population which included all participants entered into the study.
|
|
Infections and infestations
Urinary tract infection
|
0.93%
1/108 • Up to Week 24
Adverse event data was reported for the safety population which included all participants entered into the study.
|
Other adverse events
| Measure |
C.E.R.A.
n=108 participants at risk
Participants with chronic renal anemia Stage III-IV, not on dialysis, were administered C.E.R.A. according to routine clinical practice and were followed for the treatment duration of 24 weeks (6 months). Dosing and titration of C.E.R.A. treatment was at the discretion of the investigator in accordance with local clinical practice or prescribing information. Dosing instructions as per the local label were - For correction of anemia: 0.6 mcg/kg of C.E.R.A. once every two weeks, and for Maintenance of Hb levels: Conversion to C.E.R.A. dose (120, 200, or 360 mcg either once monthly; or 60, 100, or 180 mcg once every 2 weeks) depending on the previous weekly epoetin or darbepoetin dose.
|
|---|---|
|
Infections and infestations
Nasopharyngitis
|
0.93%
1/108 • Up to Week 24
Adverse event data was reported for the safety population which included all participants entered into the study.
|
|
Investigations
HIV test positive
|
0.93%
1/108 • Up to Week 24
Adverse event data was reported for the safety population which included all participants entered into the study.
|
Additional Information
Roche Trial Information Hotline
F. Hoffmann-La Roche AG
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