Anemia
Conditions
Brief summary
This observational study will evaluate the use in clinical practice and efficacy of Mircera (methoxy polyethylene glycol-epoetin beta) in chronic kidney disease patients on dialysis receiving Mircera for the treatment of chronic renal anemia. Eligible patients will be followed for 24 weeks.
Interventions
None listed
Sponsors
Hoffmann-La Roche
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Adult patients, 18 to 65 years of age, inclusive * Patients with chronic kidney disease on dialysis * ESA naïve with Hb \< 10 g/dL, or on treatment with ESAs other than Mircera and Hb within the target range of 10-12 g/dL * Adequate irons status as judged by the treating physician
Exclusion criteria
* Hypersensitivity to recombinant human erythropoietin, polyethylene glycol or to any constituent of the study medication * Clinically significant concomitant disease or disorder as defined by protocol * Clinical suspicion of pure red cell aplasia (PRCA) * Planned elective surgery during the study period , except for cataract surgery or vascular access surgery * Transfusion of red blood cells in the previous 2 months * Pregnant women * Contraindications for Mircera according to local prescribing information or as judged by the investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Had Received Treatment With Other Erythropoiesis-Stimulating Agents Maintaining Hb Level Within 1 Gram/Deciliter of Baseline Value During Study Period in Participants. | Up to Week 24 | Percentage of participants maintaining Hb level within 1 g/dL of baseline value during study period who had received treatment with other Erythropoiesis-Stimulating Agents (ESAs) were reported. |
| Mean Age of Participants Treated With C.E.R.A | Baseline (Week 0) | Age was calculated on screening/Baseline visit day by using formula: Age = (Screening visit date - Date of birth)/365.25 |
| Mean Weight of Participants Treated With C.E.R.A | Baseline (Week 0) | Weight of the participants was measured at the Baseline and summarized with descriptive statistics. |
| Number of Participants With Co-morbidity Treated With C.E.R.A | Up to Week 24 | Co-morbidity is the presence of one or more additional disorders (or diseases) co-occurring with a primary disease or disorder; or the effect of such additional disorders or diseases. Co-morbid participants with renal and urinary disorders, vascular disorders, metabolism and nutrition disorders were reported. |
| Mean Time Required to Achieve Target Hemoglobin Range | Up to Week 24 | The target range of hemoglobin (Hb) was 10-12 gram/deciliter (g/dL). Time to achieve target range = (Date of Hb evaluation when participant achieved target Hb range at first time - visit date of first dosing) + 1 |
| Percentage of Participants Achieved Target Range of Hemoglobin | Up to Week 24 | The target range of Hb was 10-12 gram/deciliter (g/dL). Time to achieve target range = (Date of Hb evaluation when participant achieved target Hb range at first time - visit date of first dosing) + 1. The percentage of participants with Hb \< 10 g/dL at enrollment, achieving the target range of hemoglobin 10-12 g/dL was reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Time Spent by Participants in the Hb Target Range | Up to Week 24 | Maintenance of target Hb was evaluated by assessing the mean time spent by participants in target Hb range. The target Hb range in the study was 10-12 g/dL. |
| Evaluation of Route of Administration for C.E.R.A | Up to Week 24 | C.E.R.A. was administered by Intravenous (IV) and Subcutaneous (SC) route of administration. The frequency (number of injections) for both of these routes of administration used in the study was reported. |
| Evaluation of Dose Per Injection of C.E.R.A | Up to Week 24 | The dosing and titration of C.E.R.A treatment were at the discretion of the investigator in accordance with local clinical practice or approved prescribing information. Mean dose per injection of C.E.R.A received by participants was reported. |
| Number of Participants Received Concomitant Medications | Up to Week 24 | Medications that were used during the study treatment period (from the first dose date of study medication to the end of the study) were included as concomitant medications. The prescribed concomitant medications (in greater than or equal to 10% of participants) in the study were prazosin, torasemide, vitamin and nutritional supplements, omeprazole, amlodipine, calcium supplements, calcitriol, and clonidine. Participants treated with the each of these concomitant medications were reported. |
| Number of Participants Achieving Hb Target Range (10-12 Hb g/dL) at Least Once During the Study | Up to Week 24 | For correction of anemia, number of participants achieving Hb target range (10-12 g/dL) at least once during the study were reported. |
Countries
India
Participant flow
Recruitment details
A total of 127 participants were enrolled from 7 centers in India. This study was conducted between 14 April 2011 and 23 September 2013.
Pre-assignment details
Out of 127 participants enrolled in the study, 1 participant was enrolled wrongly and data for 2 participants were not available at the study Centre. Therefore, 124 participants were evaluated in this study.
Participants by arm
| Arm | Count |
|---|---|
| C.E.R.A. Participants with chronic renal anemia received C.E.R.A according to routine clinical practice treatment in line with approved prescribing information for a duration of 6 months/24 weeks. | 124 |
| Total | 124 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Death | 4 |
| Overall Study | Non-compliance by the participants | 3 |
| Overall Study | Protocol Violation | 4 |
| Overall Study | Withdrawal by Subject | 10 |
Baseline characteristics
| Characteristic | C.E.R.A. |
|---|---|
| Age, Continuous | 48.1 Years STANDARD_DEVIATION 12.26 |
| Height | 157.83 Centimeters STANDARD_DEVIATION 10.056 |
| Sex: Female, Male Female | 41 Participants |
| Sex: Female, Male Male | 83 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 21 / 124 |
| serious Total, serious adverse events | 6 / 124 |
Outcome results
Primary
Mean Age of Participants Treated With C.E.R.A
Age was calculated on screening/Baseline visit day by using formula: Age = (Screening visit date - Date of birth)/365.25
Time frame: Baseline (Week 0)
Population: The safety population included all participants enrolled into the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| C.E.R.A. | Mean Age of Participants Treated With C.E.R.A | 48.1 Years | Standard Deviation 12.26 |
Primary
Mean Time Required to Achieve Target Hemoglobin Range
The target range of hemoglobin (Hb) was 10-12 gram/deciliter (g/dL). Time to achieve target range = (Date of Hb evaluation when participant achieved target Hb range at first time - visit date of first dosing) + 1
Time frame: Up to Week 24
Population: ITT population included all the participants who received at least 1 dose of C.E.R.A (Week 0) and for whom data for at least one follow-up variable was available. The analysis population reflects those participants whose Hb value was less than (\<) 10 g/dL at enrollment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| C.E.R.A. | Mean Time Required to Achieve Target Hemoglobin Range | 11.66 Week | Standard Deviation 5.652 |
Primary
Mean Weight of Participants Treated With C.E.R.A
Weight of the participants was measured at the Baseline and summarized with descriptive statistics.
Time frame: Baseline (Week 0)
Population: The safety population included all participants enrolled into the study. The analysis population reflects those participants whose weights were assessed at baseline.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| C.E.R.A. | Mean Weight of Participants Treated With C.E.R.A | 57.44 Kilograms | Standard Deviation 13.269 |
Primary
Number of Participants With Co-morbidity Treated With C.E.R.A
Co-morbidity is the presence of one or more additional disorders (or diseases) co-occurring with a primary disease or disorder; or the effect of such additional disorders or diseases. Co-morbid participants with renal and urinary disorders, vascular disorders, metabolism and nutrition disorders were reported.
Time frame: Up to Week 24
Population: The safety population included all participants enrolled into the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| C.E.R.A. | Number of Participants With Co-morbidity Treated With C.E.R.A | Total comorbid participants | 107 Number of participants |
| C.E.R.A. | Number of Participants With Co-morbidity Treated With C.E.R.A | Comorbidity, renal and urinary disorders | 63 Number of participants |
| C.E.R.A. | Number of Participants With Co-morbidity Treated With C.E.R.A | Comorbidity, vascular disorders | 61 Number of participants |
| C.E.R.A. | Number of Participants With Co-morbidity Treated With C.E.R.A | Comorbidity, metabolism and nutrition disorders | 46 Number of participants |
Primary
Percentage of Participants Achieved Target Range of Hemoglobin
The target range of Hb was 10-12 gram/deciliter (g/dL). Time to achieve target range = (Date of Hb evaluation when participant achieved target Hb range at first time - visit date of first dosing) + 1. The percentage of participants with Hb \< 10 g/dL at enrollment, achieving the target range of hemoglobin 10-12 g/dL was reported.
Time frame: Up to Week 24
Population: ITT population included all the participants who received at least 1 dose of C.E.R.A (Week 0) and for whom data for at least one follow-up variable was available. The analysis population reflects those participants whose Hb value was less than (\<) 10 g/dL at enrollment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| C.E.R.A. | Percentage of Participants Achieved Target Range of Hemoglobin | 74.7 Percentage of participants |
Primary
Percentage of Participants Who Had Received Treatment With Other Erythropoiesis-Stimulating Agents Maintaining Hb Level Within 1 Gram/Deciliter of Baseline Value During Study Period in Participants.
Percentage of participants maintaining Hb level within 1 g/dL of baseline value during study period who had received treatment with other Erythropoiesis-Stimulating Agents (ESAs) were reported.
Time frame: Up to Week 24
Population: ITT population included all the participants who received at least 1 dose of C.E.R.A (Week 0) and for whom data for at least one follow-up variable was available. The analysis population reflects those participants who had been on other ESAs and had Hb greater than or equal to (≥)10 g/dL at baseline.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| C.E.R.A. | Percentage of Participants Who Had Received Treatment With Other Erythropoiesis-Stimulating Agents Maintaining Hb Level Within 1 Gram/Deciliter of Baseline Value During Study Period in Participants. | 20 Percentage of participants |
Secondary
Evaluation of Dose Per Injection of C.E.R.A
The dosing and titration of C.E.R.A treatment were at the discretion of the investigator in accordance with local clinical practice or approved prescribing information. Mean dose per injection of C.E.R.A received by participants was reported.
Time frame: Up to Week 24
Population: The safety population included all participants enrolled into the study
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| C.E.R.A. | Evaluation of Dose Per Injection of C.E.R.A | 64.0 Microgram | Standard Deviation 21.3 |
Secondary
Evaluation of Route of Administration for C.E.R.A
C.E.R.A. was administered by Intravenous (IV) and Subcutaneous (SC) route of administration. The frequency (number of injections) for both of these routes of administration used in the study was reported.
Time frame: Up to Week 24
Population: The safety population included all participants enrolled into the study
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| C.E.R.A. | Evaluation of Route of Administration for C.E.R.A | Intravenous administration | 11 Number of injections |
| C.E.R.A. | Evaluation of Route of Administration for C.E.R.A | Subcutaneous administration | 647 Number of injections |
Secondary
Mean Time Spent by Participants in the Hb Target Range
Maintenance of target Hb was evaluated by assessing the mean time spent by participants in target Hb range. The target Hb range in the study was 10-12 g/dL.
Time frame: Up to Week 24
Population: ITT population included the participants who received at least 1 dose of C.E.R.A (Week 0) and for whom data for at least one follow-up variable was available.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| C.E.R.A. | Mean Time Spent by Participants in the Hb Target Range | 13.54 Week | Standard Deviation 6.143 |
Secondary
Number of Participants Achieving Hb Target Range (10-12 Hb g/dL) at Least Once During the Study
For correction of anemia, number of participants achieving Hb target range (10-12 g/dL) at least once during the study were reported.
Time frame: Up to Week 24
Population: ITT population included all the participants who received at least 1 dose of C.E.R.A (Week 0) and for whom data for at least one follow-up variable was available.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| C.E.R.A. | Number of Participants Achieving Hb Target Range (10-12 Hb g/dL) at Least Once During the Study | 83 Number of participants |
Secondary
Number of Participants Received Concomitant Medications
Medications that were used during the study treatment period (from the first dose date of study medication to the end of the study) were included as concomitant medications. The prescribed concomitant medications (in greater than or equal to 10% of participants) in the study were prazosin, torasemide, vitamin and nutritional supplements, omeprazole, amlodipine, calcium supplements, calcitriol, and clonidine. Participants treated with the each of these concomitant medications were reported.
Time frame: Up to Week 24
Population: The safety population included all participants enrolled into the study
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| C.E.R.A. | Number of Participants Received Concomitant Medications | 122 Number of participants |