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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-002065-12 | EudraCT Number |
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This 2 arm study will compare the efficacy and safety of monthly administration of intravenous (IV) Mircera versus epoetin alfa for the maintenance of hemoglobin levels in hemodialysis patients with chronic renal anemia. Participants currently receiving maintenance treatment with epoetin alfa will be randomized either to receive monthly injections of 120, 200 or 360 micrograms Mircera, with the starting dose derived from the dose of epoetin alfa they were receiving in the week preceding study start, or to continue on epoetin alfa treatment. The anticipated duration of study is 32 weeks, and the target sample size is 146 participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| C.E.R.A | Experimental | Participants received starting dose of 120, 200 or 360 mcg of C.E.R.A IV once monthly for 6 months. The starting dose was based on the dose of epoetin alfa administered in Week -1. |
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| Epoetin Alfa | Active Comparator | Participants received IV injection of 6000 International Units (IU) of epoetin alfa every 3 weeks (q3wk) during the Stability Verification Period (SVP; Week -4 to -1), and 7443 IU of epoetin alfa q3wk during Dose Titration Period (DTP; Week 0 to 15), 7363 IU of epoetin alfa q3wk during Efficacy Evaluation Period (EEP; Week 16 to 23) up to 23 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| methoxy polyethylene glycol-epoetin beta | Drug | 120, 200 or 360 micrograms iv/month (starting dose) |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Maintained Average Hemoglobin (Hb) Concentration Within Plus Minus (+/-) 1 Grams Per Deciliter (g/dL) of Their Reference Hb and Between 10 and 12 g/dL During the EEP | Participants who maintained average Hb concentration within +/-1 g/dL of their reference Hb and between 10 to 12 g/dL during EEP are reported. The reference Hb value was defined on the basis of all assessments at Weeks -4, -3, -2, -1 and 0. | EEP (Week 16 to 23) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hb Concentrations Between Baseline SVP and the EEP | Change in Hb concentration between baseline SVP and the EEP was evaluated by subtracting the mean of Hb concentration during the SVP (Weeks -4 to -1) with the mean of Hb concentration during the EEP (Weeks 16 to 23). | SVP (Week -4 to -1), EEP (Week 16 to 23) |
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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 |
|---|---|---|---|---|---|---|
| Badajoz | Badajoz | 06300 | Spain | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26965694 | Derived | Locatelli F, Choukroun G, Truman M, Wiggenhauser A, Fliser D. Once-Monthly Continuous Erythropoietin Receptor Activator (C.E.R.A.) in Patients with Hemodialysis-Dependent Chronic Kidney Disease: Pooled Data from Phase III Trials. Adv Ther. 2016 Apr;33(4):610-25. doi: 10.1007/s12325-016-0309-6. Epub 2016 Mar 10. |
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| ID | Title | Description |
|---|---|---|
| FG000 | C.E.R.A | Participants received starting dose of 120, 200 or 360 micrograms (mcg) of C.E.R.A intravenously (IV) once monthly for 6 months. The starting dose was based on the dose of epoetin alfa administered in Week -1. |
| FG001 | Epoetin Alfa |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Epoetin alfa | Drug | As prescribed |
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| Percentage of Participants Who Maintained Hb Concentration Between 10 and 12 g/dL Throughout the EEP |
Participants who maintained Hb concentration between 10 to 12 g/dL throughout the EEP are reported. |
| EEP (Week 16 to 23) |
| Mean Time Spent in Hb Range 10-12 g/dL | SVP (Week -4 to -1), DTP (Week 0 to 15), and EEP (Week 16 to 23) |
| Percentage of Participants Who Required Dose Adjustments During the DTP and EEP | DTP (Week 0 to 15) and EEP (Week 16 to 23) |
| Percentage of Participants Who Received Red Blood Cell (RBC) Transfusions During DTP and EEP | RBC transfusions could be given during the study in case of medical need, i.e., in severely anemic participants with recognized symptoms or signs of anemia (e.g., in participants with acute blood loss, with severe angina, or whose hemoglobin decreased to critical levels). | DTP (Week 0 to 15) up to EEP (Week 16 to 23) |
| Barcelona |
| Barcelona |
| 08035 |
| Spain |
| Cáceres | Caceres | 10310 | Spain |
| Cádizv | Cadiz | 11008 | Spain |
| Castellon | Castellon | 12004 | Spain |
| Ciudad Real | Ciudad Real | 13005 | Spain |
| Huelva | Huelva | 21005 | Spain |
| Madrid | Madrid | 28034 | Spain |
| Madrid | Madrid | 28041 | Spain |
| Madrid | Madrid | 28905 | Spain |
| Marbella | Malaga | 29603 | Spain |
| Tudela | Navarre | 46010 | Spain |
| Pontevedra | Pontevedra | 36071 | Spain |
| Salamanca | Salamanca | 37008 | Spain |
| Teruel | Teruel | 44003 | Spain |
| Valencia | Valencia | 46009 | Spain |
| Valencia | Valencia | 46010 | Spain |
| Zamora | Zamora | 49022 | Spain |
| Zaragoza | Zaragoza | 50009 | Spain |
Participants received IV injection of 6000 International Units (IU) of epoetin alfa every 3 weeks (q3wk) during the Stability Verification Period (SVP; Week -4 to -1), 7443 IU of epoetin alfa q3wk during Dose Titration Period (DTP; Week 0 to 15), and 7363 IU of epoetin alfa q3wk during Efficacy Evaluation Period (EEP; Week 16 to 23) up to 23 weeks. |
| COMPLETED |
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| NOT COMPLETED |
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Intent-to-treat (ITT) population included all participants who received at least one dose of C.E.R.A. or epoetin alfa after Week 0, 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 received starting dose of 120, 200 or 360 mcg of C.E.R.A IV once monthly for 6 months. The starting dose was based on the dose of epoetin alfa administered in Week -1. |
| BG001 | Epoetin Alfa | Participants received IV injection of 6000 IU of epoetin alfa q3wk during the SVP (Week -4 to -1), 7443 IU of epoetin alfa q3wk during DTP (Week 0 to 15), and 7363 IU of epoetin alfa q3wk during EEP (Week 16 to 23) up to 23 weeks. |
| BG002 | Total | Total of all reporting groups |
| 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 |
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| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Percentage of Participants Who Maintained Average Hemoglobin (Hb) Concentration Within Plus Minus (+/-) 1 Grams Per Deciliter (g/dL) of Their Reference Hb and Between 10 and 12 g/dL During the EEP | Participants who maintained average Hb concentration within +/-1 g/dL of their reference Hb and between 10 to 12 g/dL during EEP are reported. The reference Hb value was defined on the basis of all assessments at Weeks -4, -3, -2, -1 and 0. | Per Protocol (PP) population was as a subset of the ITT population who completed the study without any major protocol deviations. | Posted | Number | 95% Confidence Interval | percentage of participants | EEP (Week 16 to 23) |
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| Secondary | Change in Hb Concentrations Between Baseline SVP and the EEP | Change in Hb concentration between baseline SVP and the EEP was evaluated by subtracting the mean of Hb concentration during the SVP (Weeks -4 to -1) with the mean of Hb concentration during the EEP (Weeks 16 to 23). | ITT population. | Posted | Mean | Standard Deviation | g/dL | SVP (Week -4 to -1), EEP (Week 16 to 23) |
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| Secondary | Percentage of Participants Who Maintained Hb Concentration Between 10 and 12 g/dL Throughout the EEP | Participants who maintained Hb concentration between 10 to 12 g/dL throughout the EEP are reported. | ITT population | Posted | Number | percentage of participants | EEP (Week 16 to 23) |
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| Secondary | Mean Time Spent in Hb Range 10-12 g/dL | ITT population. Here, n = participants who were evaluable for each category, for respective arm groups. | Posted | Mean | Standard Deviation | days | SVP (Week -4 to -1), DTP (Week 0 to 15), and EEP (Week 16 to 23) |
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| Secondary | Percentage of Participants Who Required Dose Adjustments During the DTP and EEP | Safety population included all those participants who were treated with at least one dose of the trial medication and had a safety follow-up, whether withdrawn prematurely or not. Here, "n" = participants who were evaluable for each category, for respective arm groups. | Posted | Number | percentage of participants | DTP (Week 0 to 15) and EEP (Week 16 to 23) |
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| Secondary | Percentage of Participants Who Received Red Blood Cell (RBC) Transfusions During DTP and EEP | RBC transfusions could be given during the study in case of medical need, i.e., in severely anemic participants with recognized symptoms or signs of anemia (e.g., in participants with acute blood loss, with severe angina, or whose hemoglobin decreased to critical levels). | ITT population | Posted | Number | percentage of participants | DTP (Week 0 to 15) up to EEP (Week 16 to 23) |
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Week 0 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 | C.E.R.A | Participants received starting dose of 120, 200 or 360 mcg of C.E.R.A IV once monthly for 6 months. The starting dose was based on the dose of epoetin alfa administered in Week -1. | 16 | 65 | 11 | 65 | ||
| EG001 | Epoetin Alfa | Participants received IV injection of 6000 IU of epoetin alfa q3wk during the SVP (Week -4 to -1), 7443 IU of epoetin alfa q3wk during DTP (Week 0 to 15), and 7363 IU of epoetin alfa q3wk during EEP (Week 16 to 23) up to 23 weeks. | 4 | 36 | 9 | 36 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Acute myocardial infarction | Cardiac disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Angina pectoris | Cardiac disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Cardiac arrest | Cardiac disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Cardiac failure congestive | Cardiac disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Myocardial infarction | Cardiac disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Intestinal obstruction | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Death | General disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Cholecystitis acute | Hepatobiliary disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Bronchiectasis | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
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| Lung infection pseudomonal | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
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| Pyelonephritis | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
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| Respiratory tract infection | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
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| Hip fracture | Injury, poisoning and procedural complications | MedDRA (12.0) | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Ischaemic neuropathy | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Confusional state | Psychiatric disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Peripheral ischaemia | Vascular disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Shock | Vascular disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
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| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Hyperphosphataemia | Metabolism and nutrition disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA (12.0) | 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 |
| D000068817 | Epoetin Alfa |
| ID | Term |
|---|---|
| D004921 | Erythropoietin |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
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| Male |
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