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An observational, longitudinal, multi-center, non-interventional study in participants with chronic kidney disease (CKD) stage 3-4, assessed by Modification of Diet in Renal Disease (MDRD) to collect data regarding safety and efficacy in participants with pre-dialysis situation who are treated with MIRCERA in normal clinical environment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort of CKD Participants | Pre-dialysis participants with CKD treated with MIRCERA according to the current standard of care and in line with the current local summary of product characteristics were observed for maximum of 12 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MIRCERA | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Reaching a Hemoglobin (Hb) Value of Greater Than (>) 100 and Less Than (<) 120 Grams Per Liter (gm/L) at Month 6 Before Inclusion | Pre-baseline (Month -6) | |
| Percentage of Participants Reaching a Hb Value of >100 and < 120 gm/L at Month 3 Before Inclusion | Pre-baseline (Month -3) | |
| Percentage of Participants Reaching a Hb Value of >100 and < 120 gm/L at Baseline | Baseline | |
| Percentage of Participants Reaching a Hb Value of > 100 and < 120 gm/L at Month 3 After Inclusion | Month 3 | |
| Percentage of Participants Reaching a Hb Value of > 100 and < 120 gm/L at Month 6 After Inclusion | Month 6 | |
| Percentage of Participants Reaching a Hb Value of > 100 and < 120 gm/L at Month 9 After Inclusion | Month 9 | |
| Percentage of Participants Reaching a Hb Value of > 100 and < 120 gm/L at Month 12 After Inclusion | Month 12 | |
| Mean Hb Value at Month 6 Before Inclusion | Pre-baseline (Month -6) | |
| Mean Hb Value at Month 3 Before Inclusion | Pre-baseline (Month -3) | |
| Mean Hb Value at Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Change in MIRCERA Treatment | Change in MIRCERA treatment included changes in dose, frequency, and route of administration. | Months 3, 6, 9, and 12 |
| Percentage of Participants With Number of MIRCERA Dose Changes |
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Inclusion Criteria:
Exclusion Criteria:
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Adult participants with CKD Stage 3-4 treated with MIRCERA
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Angeholm | S-262 81 | Sweden | ||||
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| ID | Title | Description |
|---|---|---|
| FG000 | Chronic Kidney Disease (CKD) Participants | Pre-dialysis participants with CKD treated with MIRCERA according to the current standard of care and in line with the current local summary of product characteristics were observed for maximum of 12 months. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All enrolled participants with available data for baseline characteristics.
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| ID | Title | Description |
|---|---|---|
| BG000 | CKD Participants | Pre-dialysis participants with CKD treated with MIRCERA according to the current standard of care and in line with the current local summary of product characteristics were observed for maximum of 12 months. |
| 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 | Percentage of Participants Reaching a Hemoglobin (Hb) Value of Greater Than (>) 100 and Less Than (<) 120 Grams Per Liter (gm/L) at Month 6 Before Inclusion | All enrolled participants. Here, number of participants analyzed= participants with non-missing Hb assessment at specified time frame for this outcome measure. | Posted | Number | percentage of participants | Pre-baseline (Month -6) |
|
|
Pre-baseline (Month -6) to Month 12
All enrolled participants with data recorded for adverse events 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 | CKD Participants | Pre-dialysis participants with CKD treated with MIRCERA according to the current standard of care and in line with the current local summary of product characteristics were observed for maximum of 12 months. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin Reaction | Skin and subcutaneous tissue disorders | Volume 9A of EU CTD | 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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| Baseline |
| Mean Hb Value at Month 3 After Inclusion | Month 3 |
| Mean Hb Value at Month 6 After Inclusion | Month 6 |
| Mean Hb Value at Month 9 After Inclusion | Month 9 |
| Mean Hb Value at Month 12 After Inclusion | Month 12 |
| Percentage of Participants With Hb Fluctuation From Pre-Baseline (Month -6) to Baseline | Hb fluctuation was defined as change in Hb value >15 gm/L between 2 visits. | Pre-baseline (Month -6) to Baseline |
| Percentage of Participants With Hb Fluctuation From Baseline to Month 12 | Hb fluctuation was defined as change in Hb value >15 gm/L between 2 visits. | Baseline to Month 12 |
| Baseline to Month 12 |
| Correlation of Hb Levels With Underlying Disease | Baseline to 12 months |
| Correlation of Hb Levels With Levels of Inflammation | Baseline to 12 months |
| Percentage of Participants With Changes in Iron Supplement | Percentage of participants who had any change in their iron supplement medication at a specified visit were reported. | Pre-baseline (Months -6 and -3), baseline, Months 3, 6, 9 and 12 |
| Percentage of Participants With Changes in Immunosuppressive Treatment | Percentage of participants who had any change in their immunosuppressive medication at a specified visit were reported. | Pre-baseline (Months -6 and -3), baseline, Months 3, 6, 9 and 12 |
| Percentage of Participants With Changes in Antihypertensive Treatment | Percentage of participants who had any change in their antihypertensive medication at a specified visit were reported. | Pre-baseline (Months -6 and -3), baseline, Months 3, 6, 9 and 12 |
| Number of Participants With Different Medication Treatment | Number of participants who were receiving different treatments (antihypertensive, immunosuppressive, iron supplements, and others) before and/or after baseline were reported. Same participant could be reported in more than one category. | Pre-baseline (Month -6) to Month 12 |
| Percentage of Participants Who Required Blood Transfusion | Pre-baseline (Months -6 and -3), baseline, Months 3, 6, 9 and 12 |
| Percentage of Participants Who Required Renal Replacement Therapy | Renal replacement therapy was defined as hemodialysis and peritoneal dialysis. | Months 3, 6, 9, and 12 |
| Bollnäs |
| 821 81 |
| Sweden |
| Eskilstuna | 63188 | Sweden |
| Gävle | 80187 | Sweden |
| Gothenburg | 41345 | Sweden |
| Gothenburg | S-402 76 | Sweden |
| Huddinge | 14186 | Sweden |
| Jönköping | 55185 | Sweden |
| Karlshamn | S-374 80 | Sweden |
| Karlstad | 65185 | Sweden |
| Kristianstad | 29185 | Sweden |
| Linköping | S-581 85 | Sweden |
| Mölndal | S-431 80 | Sweden |
| Norrköping | 60182 | Sweden |
| Skövde | 54185 | Sweden |
| Stockholm | 17176 | Sweden |
| Stockholm | 18288 | Sweden |
| Umeå | 90185 | Sweden |
| Värnamo | 33185 | Sweden |
| Västervik | 59381 | Sweden |
| Adverse Event |
|
| Withdrawal by Subject |
|
| Refused Treatment/ Did not Cooperate |
|
| Moved and Changed Clinic |
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| Started Hemodialysis |
|
| Protocol Violation |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Participants |
|
|
| Primary | Percentage of Participants Reaching a Hb Value of >100 and < 120 gm/L at Month 3 Before Inclusion | All enrolled participants. Here, number of participants analyzed= participants with non-missing Hb assessment at specified time frame for this outcome measure. | Posted | Number | percentage of participants | Pre-baseline (Month -3) |
|
|
|
| Primary | Percentage of Participants Reaching a Hb Value of >100 and < 120 gm/L at Baseline | All enrolled participants. Here, number of participants analyzed= participants with non-missing Hb assessment at specified time frame for this outcome measure. | Posted | Number | percentage of participants | Baseline |
|
|
|
| Primary | Percentage of Participants Reaching a Hb Value of > 100 and < 120 gm/L at Month 3 After Inclusion | All enrolled participants. Here, number of participants analyzed= participants with non-missing Hb assessment at specified time frame for this outcome measure. | Posted | Number | percentage of participants | Month 3 |
|
|
|
| Primary | Percentage of Participants Reaching a Hb Value of > 100 and < 120 gm/L at Month 6 After Inclusion | All enrolled participants. Here, number of participants analyzed= participants with non-missing Hb assessment at specified time frame for this outcome measure. | Posted | Number | percentage of participants | Month 6 |
|
|
|
| Primary | Percentage of Participants Reaching a Hb Value of > 100 and < 120 gm/L at Month 9 After Inclusion | All enrolled participants. Here, number of participants analyzed= participants with non-missing Hb assessment at specified time frame for this outcome measure. | Posted | Number | percentage of participants | Month 9 |
|
|
|
| Primary | Percentage of Participants Reaching a Hb Value of > 100 and < 120 gm/L at Month 12 After Inclusion | All enrolled participants. Here, number of participants analyzed= participants with non-missing Hb assessment at specified time frame for this outcome measure. | Posted | Number | percentage of participants | Month 12 |
|
|
|
| Primary | Mean Hb Value at Month 6 Before Inclusion | All enrolled participants. Here, number of participants analyzed= participants with non-missing Hb assessment at specified time frame for this outcome measure. | Posted | Mean | Standard Deviation | gm/L | Pre-baseline (Month -6) |
|
|
|
| Secondary | Percentage of Participants With Change in MIRCERA Treatment | Change in MIRCERA treatment included changes in dose, frequency, and route of administration. | All enrolled participants. Here, number of participants analyzed= participants evaluable for this outcome measure. n = number of participants evaluable at the specified time frame. | Posted | Number | percentage of participants | Months 3, 6, 9, and 12 |
|
|
|
| Secondary | Percentage of Participants With Number of MIRCERA Dose Changes | All enrolled participants. Here, number of participants analyzed= participants with available data for this outcome measure. | Posted | Number | percentage of participants | Baseline to Month 12 |
|
|
|
| Secondary | Correlation of Hb Levels With Underlying Disease | The units usage at and between study centres did change during the study and therefore no descriptive statistics could be performed on the laboratory variables. | Posted | Baseline to 12 months |
|
|
| Secondary | Correlation of Hb Levels With Levels of Inflammation | The units usage at and between study centres did change during the study and therefore no descriptive statistics could be performed on the laboratory variables. | Posted | Baseline to 12 months |
|
|
| Secondary | Percentage of Participants With Changes in Iron Supplement | Percentage of participants who had any change in their iron supplement medication at a specified visit were reported. | All enrolled participants. Here, number of participants analyzed= participants evaluable for this outcome measure and n= participants evaluable for specified time points. | Posted | Number | percentage of participants | Pre-baseline (Months -6 and -3), baseline, Months 3, 6, 9 and 12 |
|
|
|
| Primary | Mean Hb Value at Month 3 Before Inclusion | All enrolled participants. Here, number of participants analyzed= participants with non-missing Hb assessment at specified time frame for this outcome measure. | Posted | Mean | Standard Deviation | gm/L | Pre-baseline (Month -3) |
|
|
|
| Primary | Mean Hb Value at Baseline | All enrolled participants. Here, number of participants analyzed= participants with non-missing Hb assessment at specified time frame for this outcome measure. | Posted | Mean | Standard Deviation | gm/L | Baseline |
|
|
|
| Primary | Mean Hb Value at Month 3 After Inclusion | All enrolled participants. Here, number of participants analyzed= participants with non-missing Hb assessment at specified time frame for this outcome measure. | Posted | Mean | Standard Deviation | gm/L | Month 3 |
|
|
|
| Primary | Mean Hb Value at Month 6 After Inclusion | All enrolled participants. Here, number of participants analyzed= participants with non-missing Hb assessment at specified time frame for this outcome measure. | Posted | Mean | Standard Deviation | gm/L | Month 6 |
|
|
|
| Primary | Mean Hb Value at Month 9 After Inclusion | All enrolled participants. Here, number of participants analyzed= participants with non-missing Hb assessment at specified time frame for this outcome measure. | Posted | Mean | Standard Deviation | gm/L | Month 9 |
|
|
|
| Primary | Mean Hb Value at Month 12 After Inclusion | All enrolled participants. Here, number of participants analyzed= participants with non-missing Hb assessment at specified time frame for this outcome measure. | Posted | Mean | Standard Deviation | gm/L | Month 12 |
|
|
|
| Primary | Percentage of Participants With Hb Fluctuation From Pre-Baseline (Month -6) to Baseline | Hb fluctuation was defined as change in Hb value >15 gm/L between 2 visits. | All enrolled participants. Here, number of participants analyzed= participants with at least 2 non-missing Hb assessments between pre-baseline (Month -6) and baseline. | Posted | Number | percentage of participants | Pre-baseline (Month -6) to Baseline |
|
|
|
| Primary | Percentage of Participants With Hb Fluctuation From Baseline to Month 12 | Hb fluctuation was defined as change in Hb value >15 gm/L between 2 visits. | All enrolled participants. Here, number of participants analyzed= participants with at least 2 non-missing Hb assessments between baseline and Month 12. | Posted | Number | percentage of participants | Baseline to Month 12 |
|
|
|
| Secondary | Percentage of Participants With Changes in Immunosuppressive Treatment | Percentage of participants who had any change in their immunosuppressive medication at a specified visit were reported. | All enrolled participants. Here, number of participants analyzed = participants evaluable for this outcome measure and n= participants evaluable for specified time points. | Posted | Number | percentage of participants | Pre-baseline (Months -6 and -3), baseline, Months 3, 6, 9 and 12 |
|
|
|
| Secondary | Percentage of Participants With Changes in Antihypertensive Treatment | Percentage of participants who had any change in their antihypertensive medication at a specified visit were reported. | All enrolled participants. Here, number of participants analyzed = participants evaluable for this outcome measure and n= participants evaluable for specified time points. | Posted | Number | percentage of participants | Pre-baseline (Months -6 and -3), baseline, Months 3, 6, 9 and 12 |
|
|
|
| Secondary | Number of Participants With Different Medication Treatment | Number of participants who were receiving different treatments (antihypertensive, immunosuppressive, iron supplements, and others) before and/or after baseline were reported. Same participant could be reported in more than one category. | All enrolled participants. Here, number of participants analyzed= participants evaluable for this outcome measure. | Posted | Number | participants | Pre-baseline (Month -6) to Month 12 |
|
|
|
| Secondary | Percentage of Participants Who Required Blood Transfusion | All enrolled participants. Here, number of participants analyzed= participants evaluable for this outcome measure and n= participants evaluable for specified time points. | Posted | Number | percentage of participants | Pre-baseline (Months -6 and -3), baseline, Months 3, 6, 9 and 12 |
|
|
|
| Secondary | Percentage of Participants Who Required Renal Replacement Therapy | Renal replacement therapy was defined as hemodialysis and peritoneal dialysis. | All enrolled participants. Here, number of participants analyzed= participants evaluable for this outcome measure and n= participants evaluable for specified time points. | Posted | Number | percentage of participants | Months 3, 6, 9, and 12 |
|
|
|
| 0 |
| 141 |
| 1 |
| 141 |
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 the confidential information be deleted and/or the publication to be postponed inorder to present the Sponsor's intellectual property rights.
|
| Month 9 (n= 110) |
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|
| Month 12 (n= 112) |
|
|
| Title |
|---|
| Measurements |
|---|
|
| Three changes |
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| Four changes |
|
|
| Baseline (n= 142) |
|
|
| Month 3 (n= 130) |
|
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| Month 6 (n= 115) |
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| Month 9 (n= 109) |
|
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| Month 12 (n= 112) |
|
|
|
| Baseline (n= 142) |
|
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| Month 3 (n= 129) |
|
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| Month 6 (n= 114) |
|
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| Month 9 (n= 109) |
|
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| Month 12 (n= 111) |
|
|
|
| Baseline (n= 141) |
|
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| Month 3 (n= 130) |
|
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| Month 6 (n= 115) |
|
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| Month 9 (n= 109) |
|
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| Month 12 (n= 111) |
|
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| Title | Measurements |
|---|---|
|
| Other treatment |
|
|
| Baseline (n= 142) |
|
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| Month 3 (n= 131) |
|
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| Month 6 (n= 115) |
|
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| Month 9 (n= 109) |
|
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| Month 12 (n= 110) |
|
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| Hemodialysis done: Month 9 (n= 107) |
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| Hemodialysis done: Month 12 (n= 110) |
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| Peritoneal dialysis done: Month 3 (n= 130) |
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| Peritoneal dialysis done: Month 6 (n= 113) |
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| Peritoneal dialysis done: Month 9 (n= 107) |
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| Peritoneal dialysis done: Month 12 (n= 110) |
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