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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-001747-18 | EudraCT Number |
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This single-arm study will assess the efficacy and safety of monthly administration of SC Mircera for the maintenance of hemoglobin levels in participants with chronic kidney disease on peritoneal dialysis. Participants currently receiving maintenance treatment with SC erythropoietin stimulating agents (ESAs) will receive monthly SC injections of Mircera, with the starting dose derived from the last weekly ESA they had been receiving.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mircera in Renal Anemia | Experimental | Participants will receive SC methoxy polyethylene glycol-epoetin beta (Mircera) every 4 weeks for a total of 48 weeks in this single-arm study. The first dose of 120 or 200 micrograms (mcg) will be determined by the dose of ESA received prior to administration of study treatment, while subsequent doses will be adjusted to maintain hemoglobin within the target range. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methoxy polyethylene glycol-epoetin beta | Drug | Mircera will be administered SC every 4 weeks for a total of 48 weeks. The first dose of 120 or 200 mcg will be determined by the dose of ESA received prior to administration of study treatment, while subsequent doses will be adjusted to maintain hemoglobin within the target range. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Maintained Average Hb Value Within Target Range During the EEP | Participants provided pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA. The average Hb during the EEP (Weeks 16 to 24) was calculated per participant and assessed against the target range. The percentage of participants who had average Hb during the EEP in the target range (10 to 12 g/dL) was determined as the primary endpoint. The 95 percent (%) confidence interval (CI) was calculated using the Pearson-Clopper method for exact confidence bounds. | Weeks 16 to 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Hb Values Within Target Range During the EEP | During the EEP (Weeks 16 to 24), participants provided a total of three pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA. The percentage of participants who had at least one, two, or all three Hb values during the EEP in the target range (10 to 12 g/dL) was determined. | Weeks 16 to 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 |
|---|---|---|---|---|---|---|
| Ch Notre Dame Misericorde; Hemodialyse | Ajaccio | 20303 | France | |||
| Centre Hospitalier; Hemodialyse |
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| ID | Title | Description |
|---|---|---|
| FG000 | Mircera in Chronic Kidney Disease (CKD)-Related Anemia | Participants with CKD-related anemia undergoing peritoneal dialysis and who were previously treated with erythropoiesis-stimulating agent (ESA) therapy received subcutaneous (SC) methoxy polyethylene glycol-epoetin beta (Mircera), also known as continuous erythropoietin receptor activator (CERA), every 4 weeks in this single-arm study. The first dose of 120 or 200 micrograms (mcg) during Week 0 was based upon the dose of ESA received during the initial 4-week screening period, while subsequent doses were adjusted from Weeks 4 to 12 during the dose adaptation period (DAP) to maintain target hemoglobin (Hb) concentrations within 10 to 12 grams per deciliter (g/dL). Treatment continued during a designated efficacy evaluation period (EEP) from Weeks 16 to 24 and an additional follow-up period from Weeks 28 to 48. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Change in Hb Value From Baseline to the EEP | Reference Hb was determined individually per participant as the average of all Hb values during a pre-treatment screening period (Weeks -4 to 0). Participants provided pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA. The average Hb during the EEP (Weeks 16 to 24) 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. | Baseline and Weeks 16 to 24 |
| Time Spent in the Target Range for Hb During the EEP and the Overall Treatment Period | Participants provided pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA. Time spent in the target range (10 to 12 g/dL) was defined as time from first on-target Hb measurement to time of last known on-target Hb measurement, as collected during the EEP (Weeks 16 to 24) and the overall treatment period (Weeks 0 to 48). Time spent in the target range was averaged among all participants and expressed in weeks. | Weeks 16 to 24 and Weeks 0 to 48 |
| Percentage of Participants With Hb Value Within Plus/Minus (±) 1 g/dL of Reference Hb and Within the Target Range by Study Visit | Reference Hb was determined individually per participant as the average of all Hb values during a pre-treatment screening period (Weeks -4 to 0). Participants provided pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA. The percentage of participants who had average Hb during the EEP (Weeks 16 to 24) and follow-up (Weeks 28 to 48) in the target range (10 to 12 g/dL) and within ±1 g/dL of their individual reference Hb was determined by study visit. | Baseline and Weeks 16, 20, 24, 28, 32, 36, 40, 44, 48 |
| Percentage of Participants With Cycles or Excursions | Participants provided pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA. Cycles were defined as a change in Hb greater than (>) 1.5 g/dL lasting longer than 8 weeks. Excursions were defined as half of one full cycle, or an increase ("up" excursions) or decrease ("down" excursions) >1.5 g/dL lasting longer than 4 weeks according to Hb measurements collected during the study. The percentage of participants with at least one cycle or excursion during Weeks 4 to 44 was calculated. | Weeks 4 to 44 |
| Percentage of Participants With Up Excursions | Participants provided pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA during the DAP, EEP, and follow-up. Excursions were defined as half of one full cycle, or an increase ("up" excursions) or decrease ("down" excursions) in Hb >1.5 g/dL lasting longer than 4 weeks. The percentage of participants with at least one up excursion was calculated for Weeks 4 to 16, Weeks 16 to 24, and Weeks 24 to 44. | Weeks 4 to 16, Weeks 16 to 24, Weeks 24 to 44 |
| Percentage of Participants With Down Excursions | Participants provided pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA during the DAP, EEP, and follow-up. Excursions were defined as half of one full cycle, or an increase ("up" excursions) or decrease ("down" excursions) in Hb >1.5 g/dL lasting longer than 4 weeks. The percentage of participants with at least one down excursion was calculated for Weeks 4 to 16, Weeks 16 to 24, and Weeks 24 to 44. | Weeks 4 to 16, Weeks 16 to 24, Weeks 24 to 44 |
| Percentage of Participants Who Required Any Dose Adjustment of Mircera/CERA | Study drug administration occurred monthly during treatment (Weeks 0 to 48), which began with a pre-specified dose of Mircera/CERA according to the dose of ESA administered during the initial 4-week screening period. Subsequent doses could be adjusted on the basis of Hb levels or other modification criteria. The percentage of participants who required any dose adjustment (including decreased dose, increased dose, and dose not performed) was calculated for Weeks 4 to 20, Weeks 24 to 48, and Weeks 4 to 48. | Weeks 4 to 20, Weeks 24 to 48, Weeks 4 to 48 |
| Number of Dose Adjustments of Mircera/CERA | Study drug administration occurred monthly during treatment (Weeks 0 to 48), which began with a pre-specified dose of Mircera/CERA according to the dose of ESA administered during the initial 4-week screening period. Subsequent doses could be adjusted on the basis of Hb levels or other modification criteria. The number of dose adjustments performed for each participant was averaged among all participants for Weeks 4 to 20, Weeks 24 to 48, and Weeks 4 to 48. | Weeks 4 to 20, Weeks 24 to 48, Weeks 4 to 48 |
| Absolute Change in Dose of Mircera/CERA by Study Week | Study drug administration occurred monthly during treatment (Weeks 0 to 48), which began with a pre-specified dose of Mircera/CERA according to the dose of ESA administered during the initial 4-week screening period. Subsequent doses could be adjusted on the basis of Hb levels or other modification criteria. The absolute difference in dose from the previous week was calculated at each visit and averaged among all participants. | Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 |
| Percent Change in Dose of Mircera/CERA by Study Week | Study drug administration occurred monthly during treatment (Weeks 0 to 48), which began with a pre-specified dose of Mircera/CERA according to the dose of ESA administered during the initial 4-week screening period. Subsequent doses could be adjusted on the basis of Hb levels or other modification criteria. The percent difference in dose from the previous week was calculated at each visit as [(current dose minus previous week dose) divided by previous week dose] multiplied by 100, and averaged among all participants. | Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 |
| Percentage of Participants Requiring Blood Transfusions | The percentage of participants who received at least one red blood cell transfusion during the overall treatment period (Weeks 0 to 48) was calculated. | Weeks 0 to 48 |
| Annonay |
| 07103 |
| France |
| Ch D Arras; Nephrologie | Arras | 62022 | France |
| Ch D Auxerre; Nephrologie Hemodialyse | Auxerre | 89011 | France |
| CHU Saint Jacques; Centre De Dialyse | Besançon | 25030 | France |
| Ch Germon Et Gauthier; Hemodialyse | Beuvry | 62660 | France |
| Polyclin Bordeaux Nord Aquitaine; Nephrologie - Hemodialyse | Bordeaux | 33077 | France |
| Centre D Hemodialyse Saint Roch | Cabestany | 66330 | France |
| Hopital Clemenceau; Nephrologie Hemodialyse | Caen | 14033 | France |
| Hôpital Des Brousailles; Service de Néphrologie | Cannes | 06401 | France |
| CH William Morey; Nephrologie | Chalon-sur-Saône | 71100 | France |
| Ch De Chambery; Nephrologie | Chambéry | 73011 | France |
| Hopital Manchester; Nephrologie Hemodialyse | Charleville-Mézières | 08011 | France |
| Ch Hotel Dieu; Nephrologie | Chartres | 28018 | France |
| Ch Du Cotentin Site De Cherbourg; Nephrologie | Cherbourg Octeville | 50102 | France |
| Hopital Louis Pasteur; Nephrologie - Hemodialyse | Colmar | 68024 | France |
| Ch Laennec; Nephrologie Hemodialyse | Creil | 60109 | France |
| Hopital Du Bocage; Nephrologie | Dijon | 21079 | France |
| Ch De Dunkerque; Nephrologie | Dunkirk | 59385 | France |
| Chi Eure Seine D Evreux; Nephrologie | Évreux | 27023 | France |
| Agduc Muller | La Tronche | 38701 | France |
| Anider; Pharmacie | Le Petit-Quevilly | 76143 | France |
| Hopital Calmette; Medecine General & Nephrologie Serv. | Lille | 59037 | France |
| Ch Robert Bisson; Nephrologie | Lisieux | 14107 | France |
| Aural | Lyon | 69008 | France |
| Hopital Marc Jacquet; Nephrologie Hemodialyse | Melun | 77011 | France |
| Hopital Saint Andre; Nephrologie | Metz | 57003 | France |
| Echo Nantes Confluent; Uad Montfort | Nantes | 44202 | France |
| Ch Georges Renon; Nephrologie Hemodialyse | Niort | 79021 | France |
| Hopital de La Source; Service de Nephrologie & Hemodialyse | Orléans | 45100 | France |
| Unite Autodialyse Paris 14; Dialyse A Domicile | Paris | 75014 | France |
| Ch Pitie Salpetriere; Nephrologie Hemodialyse | Paris | 75651 | France |
| Hopital Bichat Claude Bernard; Nephrologie | Paris | 75877 | France |
| Hopital Tenon; Nephrologie Dialyse | Paris | 75970 | France |
| Chu La Miletrie;Nephrologie Transplantation | Poitiers | 86021 | France |
| Ch Rene Dubos; Dialyse Peritoneale | Pontoise | 95300 | France |
| Chi De Cornouaille; Nephrologie | Quimper | 29107 | France |
| Hopital De La Maison Blanche; Nephrologie Hemodialyse | Reims | 51092 | France |
| Ch De Bourran; Nephrologie Hemodialyse | Rodez | 12027 | France |
| Aurar; Aurar St Denis | Saint-Denis | 97400 | France |
| Memorial France Etats Unis; Nephrologie | Saint-Lô | 50009 | France |
| Hopital National; Nephrologie Hemodialyse | Saint-Maurice | 94415 | France |
| Aurar | Saint-Pierre | 97410 | France |
| HOPITAL NORD; NEPH Transplantation Reanimation | Saint-Priest-en-Jarez | 42277 | France |
| CH de Saintonge; Unite 1 Med Interne Nephrologie | Saintes | 17108 | France |
| Ch De Soissons; Medecine 5 | Soissons | 02209 | France |
| Hopital Civil; Nephrologie Clinique Medicale B | Strasbourg | 67091 | France |
| Arauco; Arauco Tours Bretonneau | Tours | 37044 | France |
| Ch De Valence; Departement Medecine | Valence | 26953 | France |
| ALTIR | Vandœuvre-lès-Nancy | 54511 | France |
| CH Bretagne Atlantique de Vannes; Hemodialyse | Vannes | 56017 | France |
| Ch De Vittel; Nephrologie Hemodialyse | Vittel | 88804 | France |
| COMPLETED |
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| NOT COMPLETED |
|
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Intent-to-Treat (ITT) Population: All participants who received at least one dose of Mircera and provided at least one Hb evaluation between Weeks 0 to 24, and for whom any follow-up information was available.
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| ID | Title | Description |
|---|---|---|
| BG000 | Mircera in CKD-Related Anemia | Participants with CKD-related anemia undergoing peritoneal dialysis and who were previously treated with ESA therapy received SC Mircera/CERA every 4 weeks in this single-arm study. The first dose of 120 or 200 mcg during Week 0 was based upon the dose of ESA received during the initial 4-week screening period, while subsequent doses were adjusted from Weeks 4 to 12 during the DAP to maintain target Hb concentrations within 10 to 12 g/dL. Treatment continued during a designated EEP from Weeks 16 to 24 and an additional follow-up period from Weeks 28 to 48. |
| 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 | Percentage of Participants Who Maintained Average Hb Value Within Target Range During the EEP | Participants provided pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA. The average Hb during the EEP (Weeks 16 to 24) was calculated per participant and assessed against the target range. The percentage of participants who had average Hb during the EEP in the target range (10 to 12 g/dL) was determined as the primary endpoint. The 95 percent (%) confidence interval (CI) was calculated using the Pearson-Clopper method for exact confidence bounds. | ITT Population. The "Number of Participants Analyzed" reflects the total number of participants who provided sufficient data. | Posted | Number | 95% Confidence Interval | percentage of participants | Weeks 16 to 24 |
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| Secondary | Percentage of Participants With Hb Values Within Target Range During the EEP | During the EEP (Weeks 16 to 24), participants provided a total of three pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA. The percentage of participants who had at least one, two, or all three Hb values during the EEP in the target range (10 to 12 g/dL) was determined. | ITT Population. The "Number of Participants Analyzed" reflects the total number of participants who provided sufficient data for at least one Hb value. The number of participants who provided sufficient data for each analysis (n) is shown in the table. | Posted | Number | percentage of participants | Weeks 16 to 24 |
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| Secondary | Change in Hb Value From Baseline to the EEP | Reference Hb was determined individually per participant as the average of all Hb values during a pre-treatment screening period (Weeks -4 to 0). Participants provided pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA. The average Hb during the EEP (Weeks 16 to 24) 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. | ITT Population. The "Number of Participants Analyzed" reflects the total number of participants who provided sufficient data. | Posted | Mean | Standard Deviation | g/dL | Baseline and Weeks 16 to 24 |
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| Secondary | Time Spent in the Target Range for Hb During the EEP and the Overall Treatment Period | Participants provided pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA. Time spent in the target range (10 to 12 g/dL) was defined as time from first on-target Hb measurement to time of last known on-target Hb measurement, as collected during the EEP (Weeks 16 to 24) and the overall treatment period (Weeks 0 to 48). Time spent in the target range was averaged among all participants and expressed in weeks. | ITT Population. The "Number of Participants Analyzed" reflects the total number of participants who provided sufficient data. The number of participants who provided sufficient data within each timeframe (n) is shown in the table. | Posted | Mean | Standard Deviation | weeks | Weeks 16 to 24 and Weeks 0 to 48 |
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| Secondary | Percentage of Participants With Hb Value Within Plus/Minus (±) 1 g/dL of Reference Hb and Within the Target Range by Study Visit | Reference Hb was determined individually per participant as the average of all Hb values during a pre-treatment screening period (Weeks -4 to 0). Participants provided pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA. The percentage of participants who had average Hb during the EEP (Weeks 16 to 24) and follow-up (Weeks 28 to 48) in the target range (10 to 12 g/dL) and within ±1 g/dL of their individual reference Hb was determined by study visit. | ITT Population. The "Number of Participants Analyzed" reflects the total number of participants who provided sufficient data. The number of participants who provided sufficient data at each timepoint (n) is shown in the table. | Posted | Number | percentage of participants | Baseline and Weeks 16, 20, 24, 28, 32, 36, 40, 44, 48 |
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| Secondary | Percentage of Participants With Cycles or Excursions | Participants provided pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA. Cycles were defined as a change in Hb greater than (>) 1.5 g/dL lasting longer than 8 weeks. Excursions were defined as half of one full cycle, or an increase ("up" excursions) or decrease ("down" excursions) >1.5 g/dL lasting longer than 4 weeks according to Hb measurements collected during the study. The percentage of participants with at least one cycle or excursion during Weeks 4 to 44 was calculated. | ITT Population. The "Number of Participants Analyzed" reflects the total number of participants who provided sufficient data. | Posted | Number | percentage of participants | Weeks 4 to 44 |
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| Secondary | Percentage of Participants With Up Excursions | Participants provided pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA during the DAP, EEP, and follow-up. Excursions were defined as half of one full cycle, or an increase ("up" excursions) or decrease ("down" excursions) in Hb >1.5 g/dL lasting longer than 4 weeks. The percentage of participants with at least one up excursion was calculated for Weeks 4 to 16, Weeks 16 to 24, and Weeks 24 to 44. | ITT Population. The "Number of Participants Analyzed" reflects the total number of participants with at least one up excursion. | Posted | Number | percentage of participants | Weeks 4 to 16, Weeks 16 to 24, Weeks 24 to 44 |
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| Secondary | Percentage of Participants With Down Excursions | Participants provided pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA during the DAP, EEP, and follow-up. Excursions were defined as half of one full cycle, or an increase ("up" excursions) or decrease ("down" excursions) in Hb >1.5 g/dL lasting longer than 4 weeks. The percentage of participants with at least one down excursion was calculated for Weeks 4 to 16, Weeks 16 to 24, and Weeks 24 to 44. | ITT Population. The "Number of Participants Analyzed" reflects the total number of participants with at least one down excursion. | Posted | Number | percentage of participants | Weeks 4 to 16, Weeks 16 to 24, Weeks 24 to 44 |
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| Secondary | Percentage of Participants Who Required Any Dose Adjustment of Mircera/CERA | Study drug administration occurred monthly during treatment (Weeks 0 to 48), which began with a pre-specified dose of Mircera/CERA according to the dose of ESA administered during the initial 4-week screening period. Subsequent doses could be adjusted on the basis of Hb levels or other modification criteria. The percentage of participants who required any dose adjustment (including decreased dose, increased dose, and dose not performed) was calculated for Weeks 4 to 20, Weeks 24 to 48, and Weeks 4 to 48. | ITT Population. The "Number of Participants Analyzed" reflects the total number of participants who provided sufficient data. The number of participants who provided sufficient data for each analysis within each timeframe (n) is shown in the table. | Posted | Number | percentage of participants | Weeks 4 to 20, Weeks 24 to 48, Weeks 4 to 48 |
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| Secondary | Number of Dose Adjustments of Mircera/CERA | Study drug administration occurred monthly during treatment (Weeks 0 to 48), which began with a pre-specified dose of Mircera/CERA according to the dose of ESA administered during the initial 4-week screening period. Subsequent doses could be adjusted on the basis of Hb levels or other modification criteria. The number of dose adjustments performed for each participant was averaged among all participants for Weeks 4 to 20, Weeks 24 to 48, and Weeks 4 to 48. | ITT Population. The "Number of Participants Analyzed" reflects the total number of participants who provided sufficient data. The number of participants who provided sufficient data within each timeframe (n) is shown in the table. | Posted | Mean | Standard Deviation | dose adjustments | Weeks 4 to 20, Weeks 24 to 48, Weeks 4 to 48 |
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| Secondary | Absolute Change in Dose of Mircera/CERA by Study Week | Study drug administration occurred monthly during treatment (Weeks 0 to 48), which began with a pre-specified dose of Mircera/CERA according to the dose of ESA administered during the initial 4-week screening period. Subsequent doses could be adjusted on the basis of Hb levels or other modification criteria. The absolute difference in dose from the previous week was calculated at each visit and averaged among all participants. | ITT Population. The "Number of Participants Analyzed" reflects the total number of participants who provided sufficient data. The number of participants who provided sufficient data for each analysis at each timepoint (n) is shown in the table. | Posted | Mean | Standard Deviation | mcg | Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 |
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| Secondary | Percent Change in Dose of Mircera/CERA by Study Week | Study drug administration occurred monthly during treatment (Weeks 0 to 48), which began with a pre-specified dose of Mircera/CERA according to the dose of ESA administered during the initial 4-week screening period. Subsequent doses could be adjusted on the basis of Hb levels or other modification criteria. The percent difference in dose from the previous week was calculated at each visit as [(current dose minus previous week dose) divided by previous week dose] multiplied by 100, and averaged among all participants. | ITT Population. The "Number of Participants Analyzed" reflects the total number of participants who provided sufficient data. The number of participants who provided sufficient data for each analysis at each timepoint (n) is shown in the table. | Posted | Mean | Standard Deviation | percent change in dose | Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 |
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| Secondary | Percentage of Participants Requiring Blood Transfusions | The percentage of participants who received at least one red blood cell transfusion during the overall treatment period (Weeks 0 to 48) was calculated. | ITT Population. The "Number of Participants Analyzed" reflects the total number of participants who provided sufficient data. | Posted | Number | percentage of participants | Weeks 0 to 48 |
|
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Continuously from Weeks -4 to 48 and/or 30 days after last dose (up to approximately 1 year overall)
Safety Population: All participants who received at least one dose of Mircera and for whom any follow-up information was available.
Not provided
| 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 CKD-Related Anemia | Participants with CKD-related anemia undergoing peritoneal dialysis and who were previously treated with ESA therapy received SC Mircera/CERA every 4 weeks in this single-arm study. The first dose of 120 or 200 mcg during Week 0 was based upon the dose of ESA received during the initial 4-week screening period, while subsequent doses were adjusted from Weeks 4 to 12 during the DAP to maintain target Hb concentrations within 10 to 12 g/dL. Treatment continued during a designated EEP from Weeks 16 to 24 and an additional follow-up period from Weeks 28 to 48. | 48 | 96 | 25 | 96 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Abdominal strangulated hernia | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Intestinal polyp | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Oesophagitis haemorrhagic | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Oesophagitis ulcerative | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Peritoneal haemorrhage | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Peritonitis | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Pneumoperitoneum | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Subileus | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Umbilical hernia | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Atrioventricular block | Cardiac disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Laryngitis | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Peritoneal candidiasis | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Peritoneal infection | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Hyperthermia | General disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Oedema | General disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Product contamination microbial | General disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Fluid overload | Metabolism and nutrition disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Coma | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Mental impairment | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Arterial disorder | Vascular disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Extremity necrosis | Vascular disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Non-systematic Assessment |
| |
| Hepatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Non-systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Non-systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Clavicle fracture | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Femoral neck fracture | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Spinal compression fracture | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Macular oedema | Eye disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Post procedural complication | Injury, poisoning and procedural complications | MedDRA (12.0) | Non-systematic Assessment |
| |
| Blood glucose fluctuation | Investigations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Removal of ambulatory peritoneal catheter | Surgical and medical procedures | MedDRA (12.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Bronchitis | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (12.0) | Non-systematic Assessment |
|
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 |
Not provided
Not provided
| ID | Term |
|---|---|
| C508420 | continuous erythropoietin receptor activator |
Not provided
Not provided
Not provided
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