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| ID | Type | Description | Link |
|---|---|---|---|
| 2006-006349-15 | EudraCT Number |
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This single-arm study will assess the efficacy and safety of intravenous (IV) Mircera when administered for the maintenance of hemoglobin (Hb) levels in participants with chronic renal anemia. Individuals currently receiving maintenance treatment with epoetin alfa or darbepoetin alfa will receive monthly injections of Mircera, with the starting dose (120, 200, or 360 micrograms [mcg] IV injection) derived from the dose of epoetin alfa or darbepoetin alfa they were receiving in the week preceding study start.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mircera in Renal Anemia | Experimental | Participants with chronic renal anemia who have been previously treated with erythropoiesis-stimulating agent (ESA) therapy will receive IV Mircera every 4 weeks for a total of 24 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg will be determined by the dose of ESA received prior to administration of study treatment. Subsequent doses will be adjusted to maintain Hb concentrations within target of 10.5 and 12.5 grams per deciliter (g/dL). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methoxy polyethylene glycol-epoetin beta | Drug | Participants will receive a starting dose of 120, 200, or 360 mcg via IV injection. Thereafter, the once-monthly dose will be titrated to achieve target Hb concentrations. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Maintained Average Hb Within Plus/Minus (±) 1 g/dL of Reference Hb and Within Target Range During the Efficacy Evaluation Period (EEP) | Reference Hb was determined individually per participant as the average of all Hb values during a pre-treatment stability assessment (Weeks -4 to 0). During the EEP (Weeks 17 to 24), participants provided a total of four blood samples for Hb monitoring while on treatment with Mircera/CERA. The average Hb during the EEP was calculated per participant and assessed against the reference value. The percentage of participants who had average Hb during the EEP in the target range of 10.5 to 12.5 g/dL and within ±1 g/dL of their individual reference Hb was determined as the primary endpoint. The 95 percent (%) confidence interval (CI) was calculated using the Pearson-Clopper method for exact confidence bounds. | Weeks -4, -3, -2, -1,and 0; pre-dose (0 hours) during Weeks 18, 20, 22, and 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Time-Adjusted Hb From Baseline to EEP | Reference Hb was determined individually per participant as the average of all Hb values during a pre-treatment stability assessment (Weeks -4 to 0). During the EEP (Weeks 17 to 24), participants provided a total of four blood samples for Hb monitoring while on treatment with Mircera/CERA. The average Hb during the EEP was calculated per participant and assessed against the reference value. The mean change in Hb value between reference (i.e., "Baseline") Hb and the EEP average Hb was calculated and expressed in g/dL. |
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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 |
|---|---|---|---|---|---|---|
| Aigáleo | 12244 | Greece | ||||
| 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 | Mircera in Renal Anemia | Participants with chronic renal anemia who were previously treated with erythropoiesis-stimulating agent (ESA) therapy received intravenous methoxy polyethylene glycol-epoetin beta (Mircera), also known as continuous erythropoietin receptor activator (CERA), every 4 weeks for a total of 24 weeks in this single-arm study. The first dose of 120, 200, or 360 micrograms (mcg) was based upon the dose of ESA received prior to administration of study treatment, while subsequent doses were adjusted to maintain hemoglobin (Hb) concentrations within target of 10.5 and 12.5 grams per deciliter (g/dL). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| At Weeks -4, -3, -2, -1, and 0; pre-dose (0 hours) during Weeks 18, 20, 22, and 24 |
| Percentage of Participants Whose Hb Remained Within Target Range Throughout the EEP | During the EEP (Weeks 17 to 24), participants provided a total of four blood samples for Hb monitoring while on treatment with CERA/Mircera. The percentage of participants who maintained each single Hb measurement in the target range of 10.5 to 12.5 g/dL was determined. The 95% CI was calculated using the Pearson-Clopper method for exact confidence bounds. | Pre-dose (0 hours) during Weeks 18, 20, 22, and 24 |
| Mean Time Spent in the Target Range for Hb During the EEP | During the EEP (Weeks 17 to 24), participants provided a total of four blood samples for Hb monitoring while on treatment with Mircera/CERA. Time spent in the target range of 10.5 to 12.5 g/dL was defined as time from first on-target Hb to time of last known on-target Hb, as collected during the EEP. Time spent in the target range was averaged among all participants and expressed in days. | Pre-dose (0 hours) during Weeks 18, 20, 22, and 24 |
| Percentage of Participants Who Required Any Dose Adjustment of Mircera/CERA During the Dose Titration Period (DTP) and EEP | Study drug administration occurred monthly during the DTP (Weeks 0 to 16), which began with a pre-specified dose of Mircera/CERA according to the dose of ESA administered during Week -1. Subsequent doses could be adjusted throughout the study including during the EEP (Weeks 17 to 24) on the basis of Hb levels or other modification criteria. The percentage of participants who required a dose adjustment for any reason was calculated during the DTP and EEP. | Weeks 0, 4, 8, 12, 16, 20, and 24 |
| Number of Participants Prematurely Withdrawn From the Study to Receive Blood Transfusion | The number of participants who were prematurely withdrawn from the study to receive a blood transfusion during treatment, including the DTP (Weeks 0 and 16) and/or EEP (Weeks 17 to 24), was reported. | Continuously and at every visit from Week 0 (every week until Week 2, thereafter every 2 weeks) through Week 24 |
| Athens |
| 11362 |
| Greece |
| Athens | 11526 | Greece |
| Athens | 11527 | Greece |
| Athens | 11528 | Greece |
| Athens | 12462 | Greece |
| Athens | 18454 | Greece |
| Athens | 18536 | Greece |
| Corinthos | 20100 | Greece |
| Daphni-athens | 17237 | Greece |
| Ioannina | 455 00 | Greece |
| Kalamata | 24100 | Greece |
| Kyparissía | 24500 | Greece |
| Lamia | 35100 | Greece |
| Larissa | 41 110 | Greece |
| Larissa | 41221 | Greece |
| Livadeia | 32100 | Greece |
| Mytilene | 81100 | Greece |
| Pátrai | 26225 | Greece |
| Rhodes | 85100 | Greece |
| Thessaloniki | 546 42 | Greece |
| Thessaloniki | 54629 | Greece |
| Thessaloniki | 57001 | Greece |
| Thessaloniki | 57010 | Greece |
| COMPLETED |
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| NOT COMPLETED |
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Safety Population: All participants who received at least one dose of Mircera/CERA and had at least one safety follow-up assessment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Mircera in Renal Anemia | Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 24 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received prior to administration of study treatment, while subsequent doses were adjusted to maintain Hb concentrations within target of 10.5 and 12.5 g/dL. |
| Units | Counts |
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| 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 | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Who Maintained Average Hb Within Plus/Minus (±) 1 g/dL of Reference Hb and Within Target Range During the Efficacy Evaluation Period (EEP) | Reference Hb was determined individually per participant as the average of all Hb values during a pre-treatment stability assessment (Weeks -4 to 0). During the EEP (Weeks 17 to 24), participants provided a total of four blood samples for Hb monitoring while on treatment with Mircera/CERA. The average Hb during the EEP was calculated per participant and assessed against the reference value. The percentage of participants who had average Hb during the EEP in the target range of 10.5 to 12.5 g/dL and within ±1 g/dL of their individual reference Hb was determined as the primary endpoint. The 95 percent (%) confidence interval (CI) was calculated using the Pearson-Clopper method for exact confidence bounds. | Per Protocol (PP) Population: All participants who received at least one dose of Mircera/CERA and provided data for at least one follow-up assessment, and who fulfilled inclusion/exclusion criteria per study protocol. | Posted | Number | 95% Confidence Interval | percentage of participants | Weeks -4, -3, -2, -1,and 0; pre-dose (0 hours) during Weeks 18, 20, 22, and 24 |
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| Secondary | Mean Change in Time-Adjusted Hb From Baseline to EEP | Reference Hb was determined individually per participant as the average of all Hb values during a pre-treatment stability assessment (Weeks -4 to 0). During the EEP (Weeks 17 to 24), participants provided a total of four blood samples for Hb monitoring while on treatment with Mircera/CERA. The average Hb during the EEP was calculated per participant and assessed against the reference value. The mean change in Hb value between reference (i.e., "Baseline") Hb and the EEP average Hb was calculated and expressed in g/dL. | Intent-to-Treat (ITT) Population: All participants who received at least one dose of Mircera/CERA and provided data for at least one follow-up assessment. | Posted | Mean | Standard Deviation | g/dL | At Weeks -4, -3, -2, -1, and 0; pre-dose (0 hours) during Weeks 18, 20, 22, and 24 |
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| Secondary | Percentage of Participants Whose Hb Remained Within Target Range Throughout the EEP | During the EEP (Weeks 17 to 24), participants provided a total of four blood samples for Hb monitoring while on treatment with CERA/Mircera. The percentage of participants who maintained each single Hb measurement in the target range of 10.5 to 12.5 g/dL was determined. The 95% CI was calculated using the Pearson-Clopper method for exact confidence bounds. | ITT Population | Posted | Number | 95% Confidence Interval | percentage of participants | Pre-dose (0 hours) during Weeks 18, 20, 22, and 24 |
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| Secondary | Mean Time Spent in the Target Range for Hb During the EEP | During the EEP (Weeks 17 to 24), participants provided a total of four blood samples for Hb monitoring while on treatment with Mircera/CERA. Time spent in the target range of 10.5 to 12.5 g/dL was defined as time from first on-target Hb to time of last known on-target Hb, as collected during the EEP. Time spent in the target range was averaged among all participants and expressed in days. | ITT Population | Posted | Mean | Standard Deviation | days | Pre-dose (0 hours) during Weeks 18, 20, 22, and 24 |
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| Secondary | Percentage of Participants Who Required Any Dose Adjustment of Mircera/CERA During the Dose Titration Period (DTP) and EEP | Study drug administration occurred monthly during the DTP (Weeks 0 to 16), which began with a pre-specified dose of Mircera/CERA according to the dose of ESA administered during Week -1. Subsequent doses could be adjusted throughout the study including during the EEP (Weeks 17 to 24) on the basis of Hb levels or other modification criteria. The percentage of participants who required a dose adjustment for any reason was calculated during the DTP and EEP. | ITT Population; number (n) of participants who entered each treatment period was reported. | Posted | Number | percentage of participants | Weeks 0, 4, 8, 12, 16, 20, and 24 |
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| Secondary | Number of Participants Prematurely Withdrawn From the Study to Receive Blood Transfusion | The number of participants who were prematurely withdrawn from the study to receive a blood transfusion during treatment, including the DTP (Weeks 0 and 16) and/or EEP (Weeks 17 to 24), was reported. | All Enrolled Population: Includes all participants enrolled into the study regardless of treatment received. | Posted | Number | participants | Continuously and at every visit from Week 0 (every week until Week 2, thereafter every 2 weeks) through Week 24 |
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Continuously and at every visit from Week -4 (every week until Week 2, every 2 weeks until Week 24) through Week 28
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 | Mircera in Renal Anemia | Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 24 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received prior to administration of study treatment, while subsequent doses were adjusted to maintain Hb concentrations within target of 10.5 and 12.5 g/dL. | 34 | 188 | 10 | 188 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| 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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| Atrial fibrillation | 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 valve disease | Cardiac disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Myocardial ischaemia | Cardiac disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Gastroduodenal haemorrhage | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Gastrointestinal haemorrhage | Gastrointestinal 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 | Hepatobiliary 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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| Cholelithiasis | Hepatobiliary disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Arteriovenous graft site infection | 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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| Diabetic gangrene | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
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| Diverticulitis | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
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| Gangrene | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
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| Gastroenteritis | 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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| Septic shock | 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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| Arteriovenous fistula site complication | Injury, poisoning and procedural complications | MedDRA (12.0) | Non-systematic Assessment |
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| Arteriovenous fistula site haematoma | Injury, poisoning and procedural complications | MedDRA (12.0) | Non-systematic Assessment |
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| Arteriovenous graft thrombosis | Injury, poisoning and procedural complications | MedDRA (12.0) | Non-systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA (12.0) | Non-systematic Assessment |
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| Dactylitis | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Hydrocephalus | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Tremor | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Haematuria | Renal and urinary disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Nephrolithiasis | Renal and urinary disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Obstructive uropathy | Renal and urinary disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Amputation | Surgical and medical procedures | MedDRA (12.0) | Non-systematic Assessment |
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| Nephrectomy | Surgical and medical procedures | MedDRA (12.0) | Non-systematic Assessment |
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| Thrombophlebitis superficial | Vascular disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Thrombosis | Vascular disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| 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 |
|---|---|
| C508420 | continuous erythropoietin receptor activator |
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