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This single arm, open label, multicenter study will evaluate the safety and change in hemoglobin levels of Mircera (C.E.R.A.; methoxy polyethylene glycol-epoetin beta) in patients with chronic renal anemia who are not on dialysis. Patients will receive as a recommended starting dose 1.2 micrograms of Mircera subcutaneously every 4 weeks. The starting dose is dependent on the patient's weight. Dose adjustment may be required due to inadequate or excessive treatment response. The anticipated time on study treatment is 28 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| methoxy polyethylene glycol-epoetin beta [Mircera] | Drug | Recommended starting dose 1.2 micrograms/kg subcutaneously every 4 weeks (depending on patient's weight). Dose adjustment may be required in the event of inadequate or excessive treatment response. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Mean Hb Concentration at Week 20 | Per Protocol (PP) Population: All participants in the safety population (all enrolled participants) except participants with less than 3 recorded Hb values in Weeks 20 to 28; who missed methoxy polyethylene glycol-epoetin beta dose in Weeks 20 to 28; who withdrew before efficacy evaluation period (Weeks 20 to 28); and participants with inadequate iron status (defined as mean serum ferritin less than or equal to [≤] 100 nanogram per milliliter [ng/mL] or mean transferrin saturation [TSAT] ≤20% or mean hypochromic red blood cells [RBCs] greater than or equal to [≥] 10% during efficacy evaluation period [Weeks 20 to 28]). | Baseline (Week 0), Week 20 |
| Change From Baseline in Mean Hb Concentration at Week 24 | PP Population: All participants in the safety population (all enrolled participants) except participants with less than 3 recorded Hb values in Weeks 20 to 28; who missed methoxy polyethylene glycol-epoetin beta dose in Weeks 20 to 28; who withdrew before efficacy evaluation period (Weeks 20 to 28); and participants with inadequate iron status (defined as mean serum ferritin ≤ 100 ng/mL or TSAT ≤20% or mean hypochromic RBCs ≥ 10% during efficacy evaluation period [Weeks 20 to 28]). | Baseline (Week 0), Week 24 |
| Change From Baseline in Mean Hb Concentration at Week 28 | PP Population: All participants in the safety population (all enrolled participants) except participants with less than 3 recorded Hb values in Weeks 20 to 28; who missed methoxy polyethylene glycol-epoetin beta dose in Weeks 20 to 28; who withdrew before efficacy evaluation period (Weeks 20 to 28); and participants with inadequate iron status (defined as mean serum ferritin ≤ 100 ng/mL or TSAT ≤20% or mean hypochromic RBCs ≥ 10% during efficacy evaluation period [Weeks 20 to 28]). | Baseline (Week 0), Week 28 |
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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 |
|---|---|---|---|---|---|---|
| Mansoura Kidney Center; Nephrology | Al Mansurah | 0 | Egypt | |||
| Alexandria University; Endocrinology Department |
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| ID | Title | Description |
|---|---|---|
| FG000 | Methoxy Polyethylene Glycol-Epoetin Beta | Participants received methoxy polyethylene glycol-epoetin beta (Mircera, Continuous Erythropoietin Receptor Activator [C.E.R.A]) at a starting dose of 1.2 micrograms per kilogram (mcg/kg) administered via subcutaneous (SC) injection every 4 weeks for 28 weeks. Doses were adjusted according to individual's hemoglobin (Hb) level. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Intent-to-Treat (ITT) Population: All participants who received at least 1 dose of methoxy polyethylene glycol-epoetin beta treatment and for whom at least 1 follow-up data was available.
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| ID | Title | Description |
|---|---|---|
| BG000 | Methoxy Polyethylene Glycol-Epoetin Beta | Participants received methoxy polyethylene glycol-epoetin beta at a starting dose of 1.2 mcg/kg administered via SC injection every 4 weeks for 28 weeks. Doses were adjusted according to individual's Hb level. |
| 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 | Change From Baseline in Mean Hb Concentration at Week 20 | Per Protocol (PP) Population: All participants in the safety population (all enrolled participants) except participants with less than 3 recorded Hb values in Weeks 20 to 28; who missed methoxy polyethylene glycol-epoetin beta dose in Weeks 20 to 28; who withdrew before efficacy evaluation period (Weeks 20 to 28); and participants with inadequate iron status (defined as mean serum ferritin less than or equal to [≤] 100 nanogram per milliliter [ng/mL] or mean transferrin saturation [TSAT] ≤20% or mean hypochromic red blood cells [RBCs] greater than or equal to [≥] 10% during efficacy evaluation period [Weeks 20 to 28]). | PP Population. Here, number of participants analyzed (N) signifies those participants who were evaluable for this outcome and n signifies those participants who were evaluable for specified time-point. | Posted | Mean | Standard Deviation | Grams per deciliter (gm/dL) | Baseline (Week 0), Week 20 |
|
From screening up to 32 Weeks
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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 | Participants received methoxy polyethylene glycol-epoetin beta at a starting dose of 1.2 mcg/kg administered via SC injection every 4 weeks for 28 weeks. Doses were adjusted according to individual's Hb level. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Renal failure chronic | Renal and urinary disorders | MedDRA (14.1) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary tract infection | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-LaRoche | 800-821-8590 | genentech@druginfo.com |
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| 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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| Alexandria |
| Egypt |
| El Qahira Al Fatemeya Hospital | Cairo | Egypt |
| Kasr El Ainy University Hospital; Endocrinology Department | Cairo | Egypt |
| Nasser Institute | Cairo | Egypt |
| Other |
|
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Methoxy Polyethylene Glycol-Epoetin Beta |
Participants received methoxy polyethylene glycol-epoetin beta at a starting dose of 1.2 mcg/kg administered via SC injection every 4 weeks for 28 weeks. Doses were adjusted according to individual's Hb level. |
|
|
|
| Primary | Change From Baseline in Mean Hb Concentration at Week 24 | PP Population: All participants in the safety population (all enrolled participants) except participants with less than 3 recorded Hb values in Weeks 20 to 28; who missed methoxy polyethylene glycol-epoetin beta dose in Weeks 20 to 28; who withdrew before efficacy evaluation period (Weeks 20 to 28); and participants with inadequate iron status (defined as mean serum ferritin ≤ 100 ng/mL or TSAT ≤20% or mean hypochromic RBCs ≥ 10% during efficacy evaluation period [Weeks 20 to 28]). | PP Population. Here, number of participants analyzed (N) signifies those participants who were evaluable for this outcome. | Posted | Mean | Standard Deviation | gm/dL | Baseline (Week 0), Week 24 |
|
|
|
|
| Primary | Change From Baseline in Mean Hb Concentration at Week 28 | PP Population: All participants in the safety population (all enrolled participants) except participants with less than 3 recorded Hb values in Weeks 20 to 28; who missed methoxy polyethylene glycol-epoetin beta dose in Weeks 20 to 28; who withdrew before efficacy evaluation period (Weeks 20 to 28); and participants with inadequate iron status (defined as mean serum ferritin ≤ 100 ng/mL or TSAT ≤20% or mean hypochromic RBCs ≥ 10% during efficacy evaluation period [Weeks 20 to 28]). | PP Population. Here, number of participants analyzed (N) signifies those participants who were evaluable for this outcome | Posted | Mean | Standard Deviation | gm/dL | Baseline (Week 0), Week 28 |
|
|
|
|
| 7 |
| 70 |
| 7 |
| 70 |
| Peripheral ischemia | Vascular disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Pneumonia cytomegaloviral | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
|
| Hemoglobin decreased | Investigations | MedDRA (14.1) | Non-systematic Assessment |
|
| Complications of transplanted kidney | Injury, poisoning and procedural complications | MedDRA (14.1) | Non-systematic Assessment |
|
| Hypocalcemia | Metabolism and nutrition disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Non-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.