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This single arm study will assess the efficacy, safety and tolerability of once monthly administration of subcutaneous Mircera for the maintenance of hemoglobin levels in patients with chronic renal anemia not on dialysis.Patients will receive sc Mircera at a starting dose of 100, 120, 200 or 360 micrograms every 4 weeks, calculated from the last weekly dose of ESA previously administered. Subsequent doses will be adjusted to maintain hemoglobin levels within the target range. 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 |
|---|---|---|---|
| 1 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| methoxy polyethylene glycol-epoetin beta [Mircera] | Drug | sc every month (starting dose of 100, 120, 150 or 200 micrograms based on previous ESA therapy) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Maintaining Average Hemoglobin Concentration Within the Target Range During the Efficacy Evaluable Period (EEP) | The target hemoglobin was defined as the mean of the three assessments recorded at Weeks -4, -2, and 0 (Stability Verification Period [SVP]). EEP was an 8 week period from Weeks 17 to 24. The 95 percent (%) confidence interval (CI) was estimated using Clopper-Pearson. | EEP (Weeks 17 to 24) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hemoglobin Concentration Between SVP and the EEP | Baseline hemoglobin was defined as the mean of the three assessments recorded at Weeks -4, -2, and 0 (SVP). EEP hemoglobin was defined as the mean of the hemoglobin assessments during EEP. EEP was an 8 week period from Weeks 17 to 24. | SVP (Baseline), and EEP (Weeks 17 to 24) |
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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 |
|---|---|---|---|---|---|---|
| Inje University Busan Paik Hospital; Nephrology | Busan | 633-165 | South Korea | |||
| Kyungpook National Uni Hospital; Internal Medicine |
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| ID | Title | Description |
|---|---|---|
| FG000 | Mircera | Participants received Mircera (methoxy polyethylene glycol epoetin beta) at a starting dose of 120, 200 or 360 micrograms [mcg] (based on previous erythropoiesis stimulating agent therapy) administered via subcutaneous (SC) injection once monthly for 24 weeks. Doses were titrated based on hemoglobin levels. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Percentage of Participants Maintaining Hemoglobin Concentration Within Hemoglobin Range 10.0 to 12.0 g/dL Throughout the EEP |
EEP was an 8 week period from Weeks 17 to 24. The 95% CI was estimated using Clopper-Pearson. |
| EEP (Weeks 17 to 24) |
| Percentage of Participants Who Required Dose Adjustments During Dose Titration Period (DTP) and EEP | DTP was a 16- week period from Week 1 to Week 16, EEP was an 8-week period from Weeks 17 to 24. Dose adjustment was assessed during entire Week 1 to 24. | Weeks 1 to 24 |
| Time Spent in Hemoglobin Range of 10.0 to 12.0 g/dL During DTP and EEP | DTP was a 16- week period from Week 1 to Week 16, EEP was an 8-week period from Weeks 17 to 24. Dose adjustment was assessed during entire Week 1 to 24. | Weeks 1 to 24 |
| Average Dose of Mircera Per Month | Weeks 0-4, 4-8, 8-12, 12-16, 16-20, and 20-24 |
| Daegu |
| 700-721 |
| South Korea |
| Chungnam National Uni Hospital; Nephrology | Daejeon | 301-721 | South Korea |
| Chonnam National University Hospital | Gwangju | 61469 | South Korea |
| NHIC Ilsan Hospital | Kyonggi-do | 411-719 | South Korea |
| Seoul National Uni Hospital; Internal Medicine | Seoul | 03080 | South Korea |
| Seoul St Mary's Hospital | Seoul | 06591 | South Korea |
| Severance Hospital; Division of Nephrology | Seoul | 120-752 | South Korea |
| East-West Neo Medical Center; Division Of Nephology | Seoul | 134-837 | South Korea |
| Samsung Medical Centre; Department of Hematology & Oncology | Seoul | 135-710 | South Korea |
| COMPLETED |
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| NOT COMPLETED |
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Safety population defined as all participants who participated in the trial.
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| ID | Title | Description |
|---|---|---|
| BG000 | Mircera | Participants received Mircera (methoxy polyethylene glycol epoetin beta) at a starting dose of 120, 200 or 360 mcg (based on previous erythropoiesis stimulating agent therapy) administered via SC injection once monthly for 24 weeks. Doses were titrated based on hemoglobin levels. |
| 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 |
|
| 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 | Percentage of Participants Maintaining Average Hemoglobin Concentration Within the Target Range During the Efficacy Evaluable Period (EEP) | The target hemoglobin was defined as the mean of the three assessments recorded at Weeks -4, -2, and 0 (Stability Verification Period [SVP]). EEP was an 8 week period from Weeks 17 to 24. The 95 percent (%) confidence interval (CI) was estimated using Clopper-Pearson. | Intention-to-Treat (ITT) population included all participants who received one more dose of Mircera. | Posted | Number | 95% Confidence Interval | percentage of participants | EEP (Weeks 17 to 24) |
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| Secondary | Change in Hemoglobin Concentration Between SVP and the EEP | Baseline hemoglobin was defined as the mean of the three assessments recorded at Weeks -4, -2, and 0 (SVP). EEP hemoglobin was defined as the mean of the hemoglobin assessments during EEP. EEP was an 8 week period from Weeks 17 to 24. | ITT population. | Posted | Mean | Standard Deviation | grams per deciliter (g/dL) | SVP (Baseline), and EEP (Weeks 17 to 24) |
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| Secondary | Percentage of Participants Maintaining Hemoglobin Concentration Within Hemoglobin Range 10.0 to 12.0 g/dL Throughout the EEP | EEP was an 8 week period from Weeks 17 to 24. The 95% CI was estimated using Clopper-Pearson. | ITT population. | Posted | Number | 95% Confidence Interval | percentage of participants | EEP (Weeks 17 to 24) |
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| Secondary | Percentage of Participants Who Required Dose Adjustments During Dose Titration Period (DTP) and EEP | DTP was a 16- week period from Week 1 to Week 16, EEP was an 8-week period from Weeks 17 to 24. Dose adjustment was assessed during entire Week 1 to 24. | ITT population. | Posted | Number | percentage of participants | Weeks 1 to 24 |
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| Secondary | Time Spent in Hemoglobin Range of 10.0 to 12.0 g/dL During DTP and EEP | DTP was a 16- week period from Week 1 to Week 16, EEP was an 8-week period from Weeks 17 to 24. Dose adjustment was assessed during entire Week 1 to 24. | ITT population. Here number of participants analyzed = participants who were analyzed for the outcome measure. | Posted | Mean | Standard Deviation | days | Weeks 1 to 24 |
|
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| Secondary | Average Dose of Mircera Per Month | ITT population. Here number of participants analyzed = participants who were analyzed for the outcome measure. | Posted | Mean | Standard Deviation | microgram (mcg) | Weeks 0-4, 4-8, 8-12, 12-16, 16-20, and 20-24 |
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up to Week 28
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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 | Mircera | Participants received Mircera (methoxy polyethylene glycol epoetin beta) at a starting dose of 120, 200 or 360 mcg (based on previous erythropoiesis stimulating agent therapy) administered via SC injection once monthly for 24 weeks. Doses were titrated based on hemoglobin levels. | 31 | 191 | 90 | 191 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ischaemic cardiomyopathy | Cardiac disorders | MedDRA | Non-systematic Assessment |
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| Ventricular extrasystoles | Cardiac disorders | MedDRA | Non-systematic Assessment |
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| Glaucoma | Eye disorders | MedDRA | Non-systematic Assessment |
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| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
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| Asthenia | General disorders | MedDRA | Non-systematic Assessment |
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| Fatigue | General disorders | MedDRA | Non-systematic Assessment |
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| Generalised oedema | General disorders | MedDRA | Non-systematic Assessment |
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| Cholecystitis acute | Hepatobiliary disorders | MedDRA | Non-systematic Assessment |
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| Cholelithiasis | Hepatobiliary disorders | MedDRA | Non-systematic Assessment |
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| Appendicitis | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Herpes zoster | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Wound infection | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
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| Gout | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
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| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
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| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA | Non-systematic Assessment |
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| Azotaemia | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
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| Calculus ureteric | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
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| Diabetic nephropathy | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
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| Renal failure chronic | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Oedema | General disorders | MedDRA | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA | Non-systematic Assessment |
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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-LaRoche | 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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