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Strategic decision unrelated to safety or efficacy
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This single arm study will assess the efficacy and safety of subcutaneous Mircera for correction of anemia in participants with chronic kidney disease who are not on dialysis and are not treated with erythropoiesis-stimulating agents (ESA). Eligible participants will receive Mircera by monthly subcutaneous injections, dependent on body weight (with a starting dose of 1.2 micrograms/kilogram [mcg/kg]). The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Methoxy Polyethylene Glycol-epoetin Beta | Experimental | Methoxy polyethylene glycol-epoetin beta will be administered subcutaneously every 4 weeks (at Weeks 4, 8, 12, 16, 20, 24, 28 and 32). The starting dose will be 1.2 micrograms per kilogram (mcg/kg) body weight. Thereafter, throughout the duration of study the dose adjustments will be performed depending on the hemoglobin value. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methoxy Polyethylene Glycol-epoetin Beta | Drug | Methoxy polyethylene glycol-epoetin beta will be administered subcutaneously every 4 weeks (at Weeks 4, 8, 12, 16, 20, 24, 28 and 32). The starting dose will be 1.2 mcg/kg body weight. Thereafter, throughout the duration of study the dose adjustments will be performed depending on the hemoglobin value. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Hemoglobin Concentration Between Baseline and the Efficacy Evaluation Period (EEP) | The baseline hemoglobin was defined as the mean of the assessments recorded during the screening period (Weeks -2 and 0). EEP was the first 8 weeks (Weeks 29 to 36) following the 28 weeks dose titration period. EEP hemoglobin was defined as the mean of the assessments recorded during the EEP. | Baseline (Week -2 to 0) and EEP (Weeks 29 to 36) |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Achievement of Response | Time to achievement of response was the time (number of days) required to achieve hemoglobin levels within the range of 11.0 to 13.0 g/dL. | Baseline to Week 40 |
| Percentage of Participants Maintaining Hemoglobin Concentration Within Hemoglobin Range 11.0 to 13.0 g/dL Throughout the EEP |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tallinn | 10617 | Estonia | ||||
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| ID | Title | Description |
|---|---|---|
| FG000 | Methoxy Polyethylene Glycol-epoetin Beta | Methoxy polyethylene glycol-epoetin beta was administered subcutaneously every 4 weeks (at Weeks 4, 8, 12, 16, 20, 24, 28 and 32). The starting dose was 1.2 micrograms per kilogram (mcg/kg) body weight. Thereafter, throughout the duration of study the dose adjustments were performed depending on the hemoglobin value. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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EEP was the first 8 weeks (Weeks 29 to 36) following the 28 weeks dose titration period. The percentage of participants whose hemoglobin concentrations remained within the range of 11.0-13.0 g/dL at all assessments throughout the EEP is presented. |
| EEP (Weeks 29 to 36) |
| Percentage of Participants Maintaining Average Hemoglobin Concentration Within Hemoglobin Range 11.0 to 13.0 g/dL During the EEP | EEP was the first 8 weeks (Weeks 29 to 36) following the 28 weeks dose titration period. The percentage of participants whose average hemoglobin concentration was within the range of 11.0-13.0 g/dL during the EEP is presented. | EEP (Weeks 29 to 36) |
| Time Spent in Hemoglobin Range of 11.0 to 13.0 g/dL During the EEP | EEP was the first 8 weeks (Weeks 29 to 36) following the 28 weeks dose titration period. | EEP (Weeks 29 to 36) |
| Tallinn |
| 13419 |
| Estonia |
| Tartu | 51014 | Estonia |
| HUS | 00029 | Finland |
| Joensuu | 80210 | Finland |
| Jyväskylä | 40620 | Finland |
| Kajaani | 87140 | Finland |
| Kotka | 48210 | Finland |
| Porvoo | 06151 | Finland |
| Tampere | 33521 | Finland |
| Turku | 20521 | Finland |
| Jūrmala | LV2015 | Latvia |
| Liepāja | 3402 | Latvia |
| Riga | 1002 | Latvia |
| Riga | LV1038 | Latvia |
| Valmiera | 4201 | Latvia |
| Ventspils | LV 3601 | Latvia |
| Hønefoss | 3504 | Norway |
| Lillehammer | 2629 | Norway |
| Oslo | 0407 | Norway |
| Stavanger | 4011 | Norway |
| Trondheim | 7006 | Norway |
| COMPLETED |
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| NOT COMPLETED |
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Safety population: included all participants who were treated with at least one dose of the study medication.
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| ID | Title | Description |
|---|---|---|
| BG000 | Methoxy Polyethylene Glycol-epoetin Beta | Methoxy polyethylene glycol-epoetin beta was administered subcutaneously every 4 weeks (at Weeks 4, 8, 12, 16, 20, 24, 28 and 32). The starting dose was 1.2 mcg/kg body weight. Thereafter, throughout the duration of study the dose adjustments were performed depending on the hemoglobin value. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| 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 Change in Hemoglobin Concentration Between Baseline and the Efficacy Evaluation Period (EEP) | The baseline hemoglobin was defined as the mean of the assessments recorded during the screening period (Weeks -2 and 0). EEP was the first 8 weeks (Weeks 29 to 36) following the 28 weeks dose titration period. EEP hemoglobin was defined as the mean of the assessments recorded during the EEP. | Intent to treat (ITT) population: included all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta and for whom data for at least one study variable was available. | Posted | Mean | Standard Deviation | grams per deciliter (g/dL) | Baseline (Week -2 to 0) and EEP (Weeks 29 to 36) |
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|
| |||||||||||||||||||||||||
| Secondary | Time to Achievement of Response | Time to achievement of response was the time (number of days) required to achieve hemoglobin levels within the range of 11.0 to 13.0 g/dL. | ITT population | Posted | Mean | Standard Deviation | days | Baseline to Week 40 |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants Maintaining Hemoglobin Concentration Within Hemoglobin Range 11.0 to 13.0 g/dL Throughout the EEP | EEP was the first 8 weeks (Weeks 29 to 36) following the 28 weeks dose titration period. The percentage of participants whose hemoglobin concentrations remained within the range of 11.0-13.0 g/dL at all assessments throughout the EEP is presented. | ITT population | Posted | Number | percentage of participants | EEP (Weeks 29 to 36) |
|
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants Maintaining Average Hemoglobin Concentration Within Hemoglobin Range 11.0 to 13.0 g/dL During the EEP | EEP was the first 8 weeks (Weeks 29 to 36) following the 28 weeks dose titration period. The percentage of participants whose average hemoglobin concentration was within the range of 11.0-13.0 g/dL during the EEP is presented. | ITT population | Posted | Number | percentage of participants | EEP (Weeks 29 to 36) |
|
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| Secondary | Time Spent in Hemoglobin Range of 11.0 to 13.0 g/dL During the EEP | EEP was the first 8 weeks (Weeks 29 to 36) following the 28 weeks dose titration period. | ITT population | Posted | Mean | Standard Deviation | days | EEP (Weeks 29 to 36) |
|
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Baseline up to Week 40
Safety population
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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 | Methoxy Polyethylene Glycol-epoetin Beta | Methoxy polyethylene glycol-epoetin beta was administered subcutaneously every 4 weeks (at Weeks 4, 8, 12, 16, 20, 24, 28 and 32). The starting dose was 1.2 mcg/kg body weight. Thereafter, throughout the duration of study the dose adjustments were performed depending on the hemoglobin value. | 11 | 39 | 11 | 39 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA 15.1 | Non-systematic Assessment |
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| Arteriosclerosis coronary artery | Cardiac disorders | MedDRA 15.1 | Non-systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA 15.1 | Non-systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
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| Otitis media chronic | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
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| Postoperative wound infection | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
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| Iron deficiency | Metabolism and nutrition disorders | MedDRA 15.1 | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
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| Intra-uterine death | Pregnancy, puerperium and perinatal conditions | MedDRA 15.1 | Non-systematic Assessment |
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| Azotaemia | Renal and urinary disorders | MedDRA 15.1 | Non-systematic Assessment |
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| Postmenopausal haemorrhage | Reproductive system and breast disorders | MedDRA 15.1 | Non-systematic Assessment |
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| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
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| Foot amputation | Surgical and medical procedures | MedDRA 15.1 | Non-systematic Assessment |
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| Peripheral ischaemia | Vascular disorders | MedDRA 15.1 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary tract infection | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 15.1 | Non-systematic Assessment |
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| Urine odour abnormal | Renal and urinary disorders | MedDRA 15.1 | Non-systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 15.1 | Non-systematic Assessment |
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This study was terminated early due to strategic decision unrelated to safety or efficacy.
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 | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800-821-8590 | genentech@druginfo.com |
| ID | Term |
|---|---|
| D000740 | Anemia |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C508420 | continuous erythropoietin receptor activator |
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