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This observational, multi-center, open-label, prospective study will evaluate the relationship between serum interleukin-6 (IL-6) and C-reactive protein (CRP) levels and methoxy polyethylene glycol-epoetin beta dosage in participants with chronic kidney disease (CKD) on dialysis. Participants will be recruited who are on stable methoxy polyethylene glycol-epoetin beta maintenance therapy or will initiate therapy with methoxy polyethylene glycol-epoetin beta.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Methoxy Polyethylene Glycol-Epoetin Beta | Participants with anemia and CKD who are on dialysis therapy, and who initiate erythropoiesis-stimulating agent (ESA) treatment with methoxy polyethylene glycol-epoetin beta or who are on stable methoxy polyethylene glycol-epoetin beta maintenance therapy, will be treated according to the usual standard of care and current best practice guidelines, and will be observed during the study period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methoxy Polyethylene Glycol-Epoetin Beta | Drug | Methoxy polyethylene glycol-epoetin beta will be administered according to the usual standard of care and current best practice guidelines and will be observed during the study period. |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation Coefficient (r) Between Serum C-Reactive Protein (CRP) Level and Methoxy Polyethylene Glycol-Epoetin Beta Dose | Regression analysis and Pearson correlation were used to calculate the correlation coefficient (r). | Day 1 |
| Correlation Coefficient (r) Between Serum Interleukin-6 (IL-6) Level and Methoxy Polyethylene Glycol-Epoetin Beta Dose | Regression analysis and Pearson correlation were used to calculate the correlation coefficient (r). | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Change in Methoxy Polyethylene Glycol-Epoetin Beta Dose at Month 6 | Percentage of participants with change in methoxy polyethylene glycol-epoetin beta dose compared to baseline were reported as per the following categories: (a) No change, (b) Dose increase (1 to greater than [>] 200 micrograms per kilogram [mcg/kg]), and (c) Dose decrease (1 to >200 mcg/kg). | Month 6 |
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Inclusion Criteria:
Exclusion Criteria:
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Adult participants with CKD on dialysis therapy, either initiating ESA treatment with methoxy polyethylene glycol-epoetin beta or on stable methoxy polyethylene glycol-epoetin beta maintenance therapy. The study is to be conducted in Israel.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Haemek Hospital; Nephrology | Afula | 18101 | Israel | |||
| Barzilai Medical Centre ; Nephrology and Hypertension |
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| ID | Title | Description |
|---|---|---|
| FG000 | Methoxy Polyethylene Glycol-Epoetin Beta | Participants with anemia and chronic kidney disease (CKD) who were on dialysis therapy, and who initiated erythropoiesis-stimulating agent (ESA) treatment with methoxy polyethylene glycol-epoetin beta (Mircera) or who were on stable methoxy polyethylene glycol-epoetin beta maintenance therapy, were treated according to the usual standard of care and current best practice guidelines. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Change From Baseline in Methoxy Polyethylene Glycol-Epoetin Beta Dose at Month 6 | Baseline, Month 6 |
| Serum CRP Level | Baseline, Month 6 |
| Serum IL-6 Level | Baseline, Month 6 |
| Correlation Coefficient (r) Between Serum CRP Level and Methoxy Polyethylene Glycol-Epoetin Beta Dose at Month 6 | Regression analysis and Pearson correlation were used to calculate the correlation coefficient (r). | Month 6 |
| Correlation Coefficient (r) Between Serum IL-6 Level and Methoxy Polyethylene Glycol-Epoetin Beta Dose at Month 6 | Regression analysis and Pearson correlation were used to calculate the correlation coefficient (r). | Month 6 |
| Predictive Baseline Serum CRP Level for Participants Initiating Treatment With Methoxy Polyethylene Glycol-Epoetin Beta Dose | Day 1 |
| Predictive Baseline Serum IL-6 Level for Participants Initiating Treatment With Methoxy Polyethylene Glycol-Epoetin Beta Dose | Day 1 |
| Serum Hemoglobin Level | Baseline, Month 6 |
| Ashkelon |
| 78306 |
| Israel |
| Soroka Medical Center; Nephrology | Beersheba | 84101 | Israel |
| Bnai Zion MC; Nephrology | Haifa | 31048 | Israel |
| Carmel Medical Center; Nephrology | Haifa | 34362 | Israel |
| Wolfson MC; Nephrology | Holon | 58100 | Israel |
| Shaare Zedek Medical Center; Nrphrology Dept. | Jerusalem | 91031 | Israel |
| Hadassah Medical Orgainastion; Nephrology | Jerusalem | 91120 | Israel |
| Meir Medical Center; Nephrology Dept. | Kfar Saba | 44281 | Israel |
| Western Galilee Hospital; Nrphrology Dept. | Nahariya | 22100 | Israel |
| EMMS Nazareth; Nephrology | Nazareth | 16100 | Israel |
| Holy Family Hospital; Nephrology | Nazareth | 16100 | Israel |
| Beilinson Medical Center; Nephrology | Petah Tikva | 49100 | Israel |
| Sheba MC; Nephrology | Ramat Gan | 52621 | Israel |
| Rebecca Sief Hospital; Nephrology | Safed | 13100 | Israel |
| Sourasky MC; Dept. of Nephrology | Tel Aviv | 6423906 | Israel |
| Poria Hospital; Nephrology | Tiberias | Israel |
| Assaf-Harofeh MC; Nephrology | Zrifin | 70300 | Israel |
| COMPLETED |
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| NOT COMPLETED |
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Intention-to-Treat (ITT) population included all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta after enrollment in the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Methoxy Polyethylene Glycol-Epoetin Beta | Participants with anemia and CKD who were on dialysis therapy, and who initiated ESA treatment with methoxy polyethylene glycol-epoetin beta or who were on stable methoxy polyethylene glycol-epoetin beta maintenance therapy, were treated according to the usual standard of care and current best practice guidelines. |
| 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 |
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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 | Correlation Coefficient (r) Between Serum C-Reactive Protein (CRP) Level and Methoxy Polyethylene Glycol-Epoetin Beta Dose | Regression analysis and Pearson correlation were used to calculate the correlation coefficient (r). | ITT population. Participants with stable maintenance treatment were included in this analysis. 'Number of participants analyzed' (N) included participants evaluable for this outcome measure. | Posted | Number | correlation coefficient | Day 1 |
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| ||||||||||||||||||||||||||
| Primary | Correlation Coefficient (r) Between Serum Interleukin-6 (IL-6) Level and Methoxy Polyethylene Glycol-Epoetin Beta Dose | Regression analysis and Pearson correlation were used to calculate the correlation coefficient (r). | ITT population. Participants with stable maintenance treatment were included in this analysis. 'Number of participants analyzed' (N) included participants evaluable for this outcome measure. | Posted | Number | correlation coefficient | Day 1 |
|
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Change in Methoxy Polyethylene Glycol-Epoetin Beta Dose at Month 6 | Percentage of participants with change in methoxy polyethylene glycol-epoetin beta dose compared to baseline were reported as per the following categories: (a) No change, (b) Dose increase (1 to greater than [>] 200 micrograms per kilogram [mcg/kg]), and (c) Dose decrease (1 to >200 mcg/kg). | ITT population. Participants with stable maintenance treatment were included in this analysis. | Posted | Number | percentage of participants | Month 6 |
|
| |||||||||||||||||||||||||||
| Secondary | Change From Baseline in Methoxy Polyethylene Glycol-Epoetin Beta Dose at Month 6 | ITT population. Participants with stable maintenance treatment were included in this analysis. 'Number of participants analyzed' (N) included participants evaluable for this outcome measure. 'Number analyzed' included participants evaluable for individual categories. | Posted | Mean | Standard Deviation | mcg/kg | Baseline, Month 6 |
|
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| Secondary | Serum CRP Level | ITT population. Participants with stable maintenance treatment were included in this analysis. 'Number analyzed' included participants evaluable for individual categories. | Posted | Mean | Standard Deviation | milligrams per liter (mg/L) | Baseline, Month 6 |
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| |||||||||||||||||||||||||||
| Secondary | Serum IL-6 Level | ITT population. Participants with stable maintenance treatment were included in this analysis. 'Number analyzed' included participants evaluable for individual categories. | Posted | Mean | Standard Deviation | picograms per milliliter (pg/mL) | Baseline, Month 6 |
|
| |||||||||||||||||||||||||||
| Secondary | Correlation Coefficient (r) Between Serum CRP Level and Methoxy Polyethylene Glycol-Epoetin Beta Dose at Month 6 | Regression analysis and Pearson correlation were used to calculate the correlation coefficient (r). | ITT population. Participants with stable maintenance treatment were included in this analysis. 'Number of participants analyzed' (N) included participants evaluable for this outcome measure. | Posted | Number | correlation coefficient | Month 6 |
|
| |||||||||||||||||||||||||||
| Secondary | Correlation Coefficient (r) Between Serum IL-6 Level and Methoxy Polyethylene Glycol-Epoetin Beta Dose at Month 6 | Regression analysis and Pearson correlation were used to calculate the correlation coefficient (r). | ITT population. Participants with stable maintenance treatment were included in this analysis. 'Number of participants analyzed' (N) included participants evaluable for this outcome measure. | Posted | Number | correlation coefficient | Month 6 |
|
| |||||||||||||||||||||||||||
| Secondary | Predictive Baseline Serum CRP Level for Participants Initiating Treatment With Methoxy Polyethylene Glycol-Epoetin Beta Dose | As per change in planned analysis, this outcome was removed due to small sample size and no data was collected for this outcome. | Posted | Day 1 |
|
| ||||||||||||||||||||||||||||||
| Secondary | Predictive Baseline Serum IL-6 Level for Participants Initiating Treatment With Methoxy Polyethylene Glycol-Epoetin Beta Dose | As per change in planned analysis, this outcome was removed due to small sample size and no data was collected for this outcome. | Posted | Day 1 |
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| Secondary | Serum Hemoglobin Level | ITT population. 'Number analyzed' included participants evaluable for individual categories. | Posted | Mean | Standard Deviation | grams per deciliter (g/dL) | Baseline, Month 6 |
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Baseline up to 6 months
Safety population included all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta after enrollment in the study.
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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 with anemia and CKD who were on dialysis therapy, and who initiated ESA treatment with methoxy polyethylene glycol-epoetin beta or who were on stable methoxy polyethylene glycol-epoetin beta maintenance therapy, were treated according to the usual standard of care and current best practice guidelines. | 48 | 197 | 15 | 197 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute coronary syndrome | Cardiac disorders | MedDRA Version 19.1 | Non-systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA Version 19.1 | Non-systematic Assessment |
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| Cardio-respiratory arrest | Cardiac disorders | MedDRA Version 19.1 | Non-systematic Assessment |
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| Cardiogenic shock | Cardiac disorders | MedDRA Version 19.1 | Non-systematic Assessment |
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| Myocardial infarction | Cardiac disorders | MedDRA Version 19.1 | Non-systematic Assessment |
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| Pericardial effusion | Cardiac disorders | MedDRA Version 19.1 | Non-systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA Version 19.1 | Non-systematic Assessment |
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| Gastrointestinal hemorrhage | Gastrointestinal disorders | MedDRA Version 19.1 | Non-systematic Assessment |
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| Peritonitis | Gastrointestinal disorders | MedDRA Version 19.1 | Non-systematic Assessment |
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| Chest pain | General disorders | MedDRA Version 19.1 | Non-systematic Assessment |
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| Chills | General disorders | MedDRA Version 19.1 | Non-systematic Assessment |
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| Death | General disorders | MedDRA Version 19.1 | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA Version 19.1 | Non-systematic Assessment |
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| Autoimmune hepatitis | Hepatobiliary disorders | MedDRA Version 19.1 | Non-systematic Assessment |
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| Arteriovenous graft site infection | Infections and infestations | MedDRA Version 19.1 | Non-systematic Assessment |
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| Bacteremia | Infections and infestations | MedDRA Version 19.1 | Non-systematic Assessment |
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| Bacterial sepsis | Infections and infestations | MedDRA Version 19.1 | Non-systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA Version 19.1 | Non-systematic Assessment |
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| Device related sepsis | Infections and infestations | MedDRA Version 19.1 | Non-systematic Assessment |
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| Gangrene | Infections and infestations | MedDRA Version 19.1 | Non-systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA Version 19.1 | Non-systematic Assessment |
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| Localized infection | Infections and infestations | MedDRA Version 19.1 | Non-systematic Assessment |
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| Paronychia | Infections and infestations | MedDRA Version 19.1 | Non-systematic Assessment |
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| Peritonitis bacterial | Infections and infestations | MedDRA Version 19.1 | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA Version 19.1 | Non-systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA Version 19.1 | Non-systematic Assessment |
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| Septic shock | Infections and infestations | MedDRA Version 19.1 | Non-systematic Assessment |
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| Urosepsis | Infections and infestations | MedDRA Version 19.1 | Non-systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA Version 19.1 | Non-systematic Assessment |
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| Laryngeal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 19.1 | Non-systematic Assessment |
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| Hyperkalemia | Metabolism and nutrition disorders | MedDRA Version 19.1 | Non-systematic Assessment |
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| Hypoglycemia | Metabolism and nutrition disorders | MedDRA Version 19.1 | Non-systematic Assessment |
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| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA Version 19.1 | Non-systematic Assessment |
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| Cerebrovascular accident | Nervous system disorders | MedDRA Version 19.1 | Non-systematic Assessment |
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| Hemiplegia | Nervous system disorders | MedDRA Version 19.1 | Non-systematic Assessment |
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| Hepatic encephalopathy | Nervous system disorders | MedDRA Version 19.1 | Non-systematic Assessment |
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| Ischemic stroke | Nervous system disorders | MedDRA Version 19.1 | Non-systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA Version 19.1 | Non-systematic Assessment |
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| Transient ischemic attack | Nervous system disorders | MedDRA Version 19.1 | Non-systematic Assessment |
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| Urinary tract obstruction | Renal and urinary disorders | MedDRA Version 19.1 | Non-systematic Assessment |
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| Acute bronchitis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 19.1 | Non-systematic Assessment |
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| Bronchitis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 19.1 | Non-systematic Assessment |
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| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA Version 19.1 | Non-systematic Assessment |
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| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA Version 19.1 | Non-systematic Assessment |
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| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA Version 19.1 | Non-systematic Assessment |
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| Leg amputation | Surgical and medical procedures | MedDRA Version 19.1 | Non-systematic Assessment |
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| Aortic stenosis | Vascular disorders | MedDRA Version 19.1 | Non-systematic Assessment |
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| Femoral artery occlusion | Vascular disorders | MedDRA Version 19.1 | Non-systematic Assessment |
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| Microscopic polyangiitis | Vascular disorders | MedDRA Version 19.1 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA Version 19.1 | Non-systematic Assessment |
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| Extrasystoles | Cardiac disorders | MedDRA Version 19.1 | Non-systematic Assessment |
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| Supraventricular tachycardia | Cardiac disorders | MedDRA Version 19.1 | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA Version 19.1 | Non-systematic Assessment |
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| Asthenia | General disorders | MedDRA Version 19.1 | Non-systematic Assessment |
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| Breast cellulitis | Infections and infestations | MedDRA Version 19.1 | Non-systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA Version 19.1 | Non-systematic Assessment |
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| Infection | Infections and infestations | MedDRA Version 19.1 | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA Version 19.1 | Non-systematic Assessment |
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| Venous pressure increased | Investigations | MedDRA Version 19.1 | Non-systematic Assessment |
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| Food intolerance | Metabolism and nutrition disorders | MedDRA Version 19.1 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA Version 19.1 | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 19.1 | Non-systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 19.1 | Non-systematic Assessment |
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| Diabetic foot | Skin and subcutaneous tissue disorders | MedDRA Version 19.1 | Non-systematic Assessment |
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| Arteriovenous fistula operation | Surgical and medical procedures | MedDRA Version 19.1 | Non-systematic Assessment |
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| Leg amputation | Surgical and medical procedures | MedDRA Version 19.1 | Non-systematic Assessment |
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| Toe amputation | Surgical and medical procedures | MedDRA Version 19.1 | Non-systematic Assessment |
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| Arteriovenous fistula | Vascular disorders | MedDRA Version 19.1 | Non-systematic Assessment |
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| Deep vein thrombosis | Vascular disorders | MedDRA Version 19.1 | Non-systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA Version 19.1 | Non-systematic Assessment |
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The study was completed as defined in the protocol. Only 197 participants (out of planned 400) were enrolled due to slow recruitment during the study period.
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 |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C508420 | continuous erythropoietin receptor activator |
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