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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline (Week 0) |
| Mean Weight of Participants Treated With C.E.R.A | Weight of the participants was measured at the Baseline and summarized with descriptive statistics. | Baseline (Week 0) |
| 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. | Up to Week 24 |
| 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 | Up to Week 24 |
| 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. | Up to Week 24 |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to Week 24 |
| Mean Time Spent by Participants in the Hb Target Range |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with chronic kidney disease on dialysis receiving treatment with Mircera for chronic renal anemia
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sir Gangaram Hospital | New Delhi | National Capital Territory of Delhi | 110060 | India | ||
| Ahmedabad Dialysis Centre |
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.
A total of 127 participants were enrolled from 7 centers in India. This study was conducted between 14 April 2011 and 23 September 2013.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Intention-to-Treat (ITT) population included all the participants who received at least 1 dose of C.E.R.A and for whom data for at least one follow-up variable was available
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | The safety population included all participants enrolled into the study. | Posted | Mean | Standard Deviation | Years | Baseline (Week 0) |
|
|
Up to Week 24
An Adverse Event is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Peritonitis | Gastrointestinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Peritonitis | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Roche Trial Information Hotline | F. Hoffmann-La Roche AG | +41 616878333 | global.trial_information@roche.com |
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| ID | Term |
|---|---|
| D000740 | Anemia |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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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. |
| 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. |
| Up to Week 24 |
| 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. | Up to Week 24 |
| 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. | Up to Week 24 |
| 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. | Up to Week 24 |
| Ahmedabad |
| 380005 |
| India |
| Excel Center | Guwahati | 781007 | India |
| ESIS Hospital; Department of Nephrology | Kolkata | 600054 | India |
| Vertex Hospital | Mumbai | 400083 | India |
| Apollo Indraprastha Hospitals; Nephrology | New Delhi | 110076 | India |
| Aditya Birla Memorial Hospital | Pune | 411033 | India |
| Withdrawal by Subject |
|
| Non-compliance by the participants |
|
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Height | For mean height of participants n = 112 as height of some participants was not captured. | Mean | Standard Deviation | Centimeters |
|
|
|
| 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. | The safety population included all participants enrolled into the study. The analysis population reflects those participants whose weights were assessed at baseline. | Posted | Mean | Standard Deviation | Kilograms | Baseline (Week 0) |
|
|
|
| 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. | The safety population included all participants enrolled into the study. | Posted | Number | Number of participants | Up to Week 24 |
|
|
|
| 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 | 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. | Posted | Mean | Standard Deviation | Week | Up to Week 24 |
|
|
|
| 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. | 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. | Posted | Number | Percentage of participants | Up to Week 24 |
|
|
|
| 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. | 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. | Posted | Number | Number of participants | Up to Week 24 |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | Week | Up to Week 24 |
|
|
|
| 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. | The safety population included all participants enrolled into the study | Posted | Number | Number of injections | Up to Week 24 |
|
|
|
| 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. | The safety population included all participants enrolled into the study | Posted | Mean | Standard Deviation | Microgram | Up to Week 24 |
|
|
|
| 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. | The safety population included all participants enrolled into the study | Posted | Number | Number of participants | Up to Week 24 |
|
|
|
| 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. | 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. | Posted | Number | Percentage of participants | Up to Week 24 |
|
|
|
| 6 |
| 124 |
| 21 |
| 124 |
| Asthenia | General disorders | Systematic Assessment | General Disorders And Administrations |
|
| Death | General disorders | Systematic Assessment | General Disorders And Administrations |
|
| Pneumonia | Infections and infestations | Systematic Assessment |
|
| Chronic renal failure | Renal and urinary disorders | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Chills | General disorders | Systematic Assessment | General Disorders And Administrations |
|
| Pyrexia | General disorders | Systematic Assessment | General Disorders And Administrations |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
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.
| Title | Measurements |
|---|---|
|
| Comorbidity, metabolism and nutrition disorders |
|