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| ID | Type | Description | Link |
|---|---|---|---|
| 2006-006523-40 | EudraCT Number |
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The study was terminated due to the slow recruitment rate.
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This single arm study will assess the efficacy, safety and tolerability of subcutaneous methoxy polyethylene glycol-epoetin beta (C.E.R.A.) for maintenance of hemoglobin levels in pre-dialysis participants with chronic renal anemia. Participants currently receiving maintenance treatment with subcutaneous darbepoetin alfa will receive monthly subcutaneous injections of C.E.R.A. with the starting dose of 120, 200 or 360 micrograms (mcg) derived from the dose of darbepoetin alfa or epoetin alfa in the week preceding study start.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| C.E.R.A. | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methoxy polyethylene glycol-epoetin beta (C.E.R.A.) | Drug | Subcutaneous methoxy polyethylene glycol-epoetin beta (C.E.R.A.) at starting dose of 120, 200, or 360 mcg every 4 weeks for 20 weeks. Further dose adjustments will be performed during the study depending on the participant's blood hemoglobin levels. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Maintaining Mean Hemoglobin Concentration Within Plus or Minus (+/-) 1 Gram Per Deciliter (g/dL) of Their Reference Hemoglobin and Within the Target Range | Percentage of participants maintaining the mean hemoglobin concentration within +/- 1.0 g/dL of their reference hemoglobin value and within the target range of 10.5 to 12.5 g/dL during the efficacy evaluation period (EEP) was reported. The reference hemoglobin value was defined as the mean of the 5 assessments recorded during the stability verification period (SVP) at Weeks -4, -3, -2, -1 and 0. The mean hemoglobin concentration for each individual participant during the EEP (Week 17 to Week 24) was estimated as a time adjusted average. | Week 17 up to Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hemoglobin Concentration Between Reference (SVP) and EEP | The reference hemoglobin value was defined as the mean of the 5 assessments recorded during the SVP at Weeks -4, -3, -2, -1 and 0. The mean change of the time adjusted average of hemoglobin from reference value obtained during the SVP (Week -4 up to Week 0) and the value during EEP (Week 17 up to Week 24) was assessed. | Week 17 up to Week 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 |
|---|---|---|---|---|---|---|
| Danderyd | 18288 | Sweden | ||||
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| ID | Title | Description |
|---|---|---|
| FG000 | C.E.R.A. | Participants received subcutaneous methoxy polyethylene glycol-epoetin beta (C.E.R.A.) at starting dose of 120, 200, or 360 micrograms (mcg) every 4 weeks for 20 weeks. Further dose adjustments were performed during the study depending on the participant's blood hemoglobin levels. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Percentage of Participants Maintaining Hemoglobin Concentration Within the Target Range During EEP | Percentage of participants maintaining hemoglobin concentration within the target range of 10.5 to 12.5 g/dL during EEP (Week 17 to Week 24) was reported. | Week 17 up to Week 24 |
| Mean Time Spent by Participants With Hemoglobin Concentration in the Target Range During the EEP | Mean time spent by participants with hemoglobin concentration within the target range of 10.5 to 12.5 g/dL during the EEP (Week 17 to Week 24) was reported. | Week 17 up to Week 24 |
| Percentage of Participants Requiring Any Dose Adjustment | Percentage of participants requiring any adjustment in the dose of study drug during the dose titration period (DTP: Week 1 to Week 16) and EEP (Week 17 to Week 24) was reported. | Week 1 up to Week 16 and Week 17 up to Week 24 |
| Percentage of Participants With Red Blood Cell Transfusion During the Study | Percentage of participant who required red blood cell transfusion during the study was reported. | Week 0 up to Week 24 |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both serious as well as non-serious AEs. | Week 0 up to Week 24 |
| Eksjö |
| 57581 |
| Sweden |
| Eskilstuna | 63188 | Sweden |
| Gävle | 80187 | Sweden |
| Gothenburg | 41345 | Sweden |
| Gothenburg | S-402 76 | Sweden |
| Huddinge | 14186 | Sweden |
| Jönköping | 55185 | Sweden |
| Kristianstad | 29185 | Sweden |
| Skellefteå | S-931 86 | Sweden |
| Stockholm | 17176 | Sweden |
| Umeå | 90185 | Sweden |
| Värnamo | 33185 | Sweden |
| Västervik | 59381 | Sweden |
| COMPLETED |
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| NOT COMPLETED |
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The safety population included all participants who were treated with at least 1 dose of the study drug and a safety follow-up, whether withdrawn prematurely or not.
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| ID | Title | Description |
|---|---|---|
| BG000 | C.E.R.A. | Participants received subcutaneous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 20 weeks. Further dose adjustments were performed during the study depending on the participant's blood 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 |
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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 Maintaining Mean Hemoglobin Concentration Within Plus or Minus (+/-) 1 Gram Per Deciliter (g/dL) of Their Reference Hemoglobin and Within the Target Range | Percentage of participants maintaining the mean hemoglobin concentration within +/- 1.0 g/dL of their reference hemoglobin value and within the target range of 10.5 to 12.5 g/dL during the efficacy evaluation period (EEP) was reported. The reference hemoglobin value was defined as the mean of the 5 assessments recorded during the stability verification period (SVP) at Weeks -4, -3, -2, -1 and 0. The mean hemoglobin concentration for each individual participant during the EEP (Week 17 to Week 24) was estimated as a time adjusted average. | The Intention-to-treat (ITT) population included all participants who received at least 1 dose of C.E.R.A. (week 0) and for whom data for at least 1 follow-up variable was available. Data missing at the end of the EEP (that is, the last measured hemoglobin value before Week 24) was handled using the last value carried forward method. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 17 up to Week 24 |
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| Secondary | Change in Hemoglobin Concentration Between Reference (SVP) and EEP | The reference hemoglobin value was defined as the mean of the 5 assessments recorded during the SVP at Weeks -4, -3, -2, -1 and 0. The mean change of the time adjusted average of hemoglobin from reference value obtained during the SVP (Week -4 up to Week 0) and the value during EEP (Week 17 up to Week 24) was assessed. | ITT population; data missing at the end of the EEP was handled using the last value carried forward method. | Posted | Mean | Standard Deviation | g/dL | Week 17 up to Week 24 |
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| Secondary | Percentage of Participants Maintaining Hemoglobin Concentration Within the Target Range During EEP | Percentage of participants maintaining hemoglobin concentration within the target range of 10.5 to 12.5 g/dL during EEP (Week 17 to Week 24) was reported. | ITT Population; data missing at the end of the EEP was handled using the last value carried forward method. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 17 up to Week 24 |
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| Secondary | Mean Time Spent by Participants With Hemoglobin Concentration in the Target Range During the EEP | Mean time spent by participants with hemoglobin concentration within the target range of 10.5 to 12.5 g/dL during the EEP (Week 17 to Week 24) was reported. | ITT Population | Posted | Mean | Standard Deviation | days | Week 17 up to Week 24 |
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| Secondary | Percentage of Participants Requiring Any Dose Adjustment | Percentage of participants requiring any adjustment in the dose of study drug during the dose titration period (DTP: Week 1 to Week 16) and EEP (Week 17 to Week 24) was reported. | ITT Population. Here, 'n' signifies the number of participants evaluable for specified category. | Posted | Number | percentage of participants | Week 1 up to Week 16 and Week 17 up to Week 24 |
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| Secondary | Percentage of Participants With Red Blood Cell Transfusion During the Study | Percentage of participant who required red blood cell transfusion during the study was reported. | ITT Population | Posted | Number | percentage of participants | Week 0 up to Week 24 |
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| Secondary | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both serious as well as non-serious AEs. | Safety population | Posted | Number | participants | Week 0 up to Week 24 |
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Week 0 up to Week 24
Only adverse events with an onset date after the start of medication were included.
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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 subcutaneous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 20 weeks. Further dose adjustments were performed during the study depending on the participant's blood hemoglobin levels. | 9 | 29 | 10 | 29 |
| 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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| Atrial fibrillation | Cardiac disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Oedema | General disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Diabetic foot infection | 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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| Wound infection | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
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| Arteriovenous fistula thrombosis | Injury, poisoning and procedural complications | MedDRA (12.0) | Non-systematic Assessment |
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| Renal impairment | Renal and urinary disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Dialysis device insertion | Surgical and medical procedures | MedDRA (12.0) | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Fatigue | General 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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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA (12.0) | Non-systematic Assessment |
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The study was terminated early due to the slow recruitment rate.
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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