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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-004779-39 | EudraCT Number |
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Ascertain the starting dose of Mircera given subcutaneously for the maintenance treatment of anemia in pediatric participants with chronic kidney disease (CKD) on dialysis or not yet on dialysis when switching from stable subcutaneous (SC) maintenance treatment with epoetin alfa, epoetin beta, or darbepoetin alfa.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mircera | Experimental | Mircera will be administered subcutaneously once every 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mircera | Drug | The initial dose of Mircera will be one of nine starting doses corresponding to the prefilled syringe strengths based on the total weekly erythropoiesis-stimulating agent (ESA) dose during the screening period. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hemoglobin (Hb) Concentration Between the Baseline and the Evaluation Period for Each Patient | The Hb change from baseline was calculated on a per-participant basis using an individual's average for both the baseline and evaluation periods and taking the difference. The baseline period was defined as the time between the day of first study dose and the previous 35 days. The evaluation period was defined as the period between Week 17 and Week 21, inclusive. | Baseline up to Week 21 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With an Average Hb Concentration During the Evaluation Period Within ± 1 g/dL of Their Baseline Hb and Above, Within or Below the Range of 10-12 g/dL | Number of participants with an average Hb concentration during the evaluation period within ± 1 g/dL of their baseline Hb is reported as well as the number of participants with an average Hb concentration above, within or below the range of 10-12 g/dL. The evaluation period was defined as the period between Week 17 and Week 21 inclusive. |
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Inclusion Criteria:
Participants with fewer than or more than three HD sessions per week should have a weekly Kt/V≥ 3.6.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham; Pediatric Nephrology | Birmingham | Alabama | 35233 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36587890 | Derived | Warady BA, Meyer Reigner S, Tirodkar C, Drozdz D. Subcutaneous C.E.R.A. for the Maintenance Treatment of Anemia in Pediatric Patients With CKD: A Phase 2, Open-Label, Single-Arm, Multicenter Study. Am J Kidney Dis. 2023 Jun;81(6):684-694.e1. doi: 10.1053/j.ajkd.2022.11.006. Epub 2022 Dec 29. |
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A total of 40 pediatric participants (ages 3 months to 17 years) with a diagnosis of anemia due to chronic kidney disease (CKD) who may or may not have been on dialysis at the time of study start were switched from stable subcutaneous (SC) maintenance treatment with epoetin alfa/beta or darbepoetin to methoxy polyethylene glycol-epoetin beta (Mircera).
The core study was 23 weeks and consisted of three periods: screening (3 weeks), dose titration (16 weeks) and evaluation (4 weeks). Participants completing the 20 weeks of treatment with hemoglobin (Hb) within +/- 1g/dL of their baseline and within the target range of 10-12 g/dL were eligible to enter an optional 24-week safety extension period.
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| ID | Title | Description |
|---|---|---|
| FG000 | Mircera | Mircera was administered subcutaneously once every 4 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Core Period |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 7, 2018 | Jan 18, 2022 |
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|
| Week 17 up to Week 21 |
| Mean Hb Values and Change From Baseline | The mean Hb concentration over time and the mean change in Hb from baseline over time are presented. | Baseline, Weeks 3, 5, 9, 13, 17, 19, 21, 25, 29, 33, 37, 41, 45 |
| Change in Mircera Dose Over Time | A dose change was defined as a change in the administered dose strength compared to the preceding dose. | Week 1 to Week 17 |
| Ratio of Mircera Starting Dose (Week 1) to the Dose at Week 17 | The ratio of Mircera dose was calculated as the median (min-max) ratio of starting dose (Week 1) to the dose at Week 17. Participants who withdrew before Week 17 or who were not administered a Mircera dose at Week 17 visit due to the applicable dose adjustment rules were excluded from the ratio computation. | Week 1, Week 17 |
| Number of Participants With Adverse Events by Severity as Assessed by Highest World Health Organization (WHO) Toxicity Grade | An adverse event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product, any new disease, or exacerbation of existing disease (a worsening in the character, frequency, or severity of a known condition), recurrence of an intermittent medical condition or any deterioration in a laboratory value or other clinical test. | Baseline up to Week 45 |
| Bioavailability (F) of Mircera in Pediatric Participants Based on Population PK Model | Bioavailability (F) is defined as the percentage of the administered drug, that reaches the systemic circulation. A population PK model was developed for Mircera that adequately describes pediatric data: a 1-compartment model with first order absorption and elimination processes. The bioavailability (F) was estimated using all the data points listed under time frame using the population PK model. | Pre-dose at Week 1, 9, 17; Post-dose at Week 3, Week 19 and additional sample taken between 24 hours and 5 days at participant's convenience |
| Loma Linda University health |
| Loma Linda |
| California |
| 92354 |
| United States |
| Emory University School of Med; Pediatrics | Atlanta | Georgia | 30322 | United States |
| Children'S Mercy Hospital; Pediatric Nephrology | Kansas City | Missouri | 64108 | United States |
| RWJBarnabas Health | West Orange | New Jersey | 07052 | United States |
| East Carolina University; Brody School of Medicine | Greenville | North Carolina | 27834 | United States |
| UT Southwestern Medical Center; Pediatrics Dept. | Dallas | Texas | 75390 | United States |
| Hopital Jeanne De Flandre; Pediatrie | Lille | 59037 | France |
| Gh Necker Enfants Malades; Nephrologie | Paris | 75743 | France |
| Höpital Hautepierre; Pediatrie 1 | Strasbourg | 67098 | France |
| Semmelweis University; 1st Department of Pediatrics, Pediatric Nephrology Center | Budapest | 1083 | Hungary |
| Debreceni Egyetem Klinikai Központ; Gyermekklinika | Debrecen | 4032 | Hungary |
| Clinica Pediatrica II De Marchi | Milan | Lombardy | 20122 | Italy |
| Ospedale Infantile Regina Margherita; U.O. Autonoma di Nefrologia, Dialisi e Trapianto | Turin | Piedmont | 10126 | Italy |
| Vilnius University Children's Hospital | Vilnius | LT-08406 | Lithuania |
| Uniwersyteckie Centrum Kliniczne; Klinika Chorob Nerek i Nadciśnienia Dzieci i Mlodziezy | Gdansk | 80-952 | Poland |
| Uniwersytecki Szpital Dziecięcy w Krakowie; Oddz.Nefrologii i Nadciśnienia Tętniczego/Stacja Dializ | Krakow | 30-663 | Poland |
| Instytut "Centrum Zdrowia Matki Polki; Klinika Pediatrii i Immunologii i Nefrologii | Lodz | 93-338 | Poland |
| Szpital Specjalistyczny dla Dzieci i Doroslych; Oddzial Kliniczny Pediatrii i Nefrologii | Torun | 87-100 | Poland |
| Szpital Kliniczny nr 1 im. prof. Szyszko; Oddz. Nefrologii Dzieciecej z Pododdziałem Dializoterapii | Zabrze | 41-800 | Poland |
| Hospital Universitari Vall d'Hebron; Servicio de Nefrologia | Barcelona | 08035 | Spain |
| Hospital Universitario Virgen del Rocio; Servicio de Nefrologia Pediatrica | Seville | 41013 | Spain |
| COMPLETED |
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| NOT COMPLETED |
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| Safety Extension Period |
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Intent to Treat (ITT) population included all participants enrolled in the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Mircera | Mircera was administered subcutaneously once every 4 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| 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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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | 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 | Change in Hemoglobin (Hb) Concentration Between the Baseline and the Evaluation Period for Each Patient | The Hb change from baseline was calculated on a per-participant basis using an individual's average for both the baseline and evaluation periods and taking the difference. The baseline period was defined as the time between the day of first study dose and the previous 35 days. The evaluation period was defined as the period between Week 17 and Week 21, inclusive. | ITT population included all participants enrolled in the study. Number analyzed is the number of participants with Hb concentration assessment at specified time points. | Posted | Mean | Standard Deviation | grams/deciliter (g/dL) | Baseline up to Week 21 |
|
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| ||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With an Average Hb Concentration During the Evaluation Period Within ± 1 g/dL of Their Baseline Hb and Above, Within or Below the Range of 10-12 g/dL | Number of participants with an average Hb concentration during the evaluation period within ± 1 g/dL of their baseline Hb is reported as well as the number of participants with an average Hb concentration above, within or below the range of 10-12 g/dL. The evaluation period was defined as the period between Week 17 and Week 21 inclusive. | ITT population included all participants enrolled in the study. Hb values within 21 days after blood transfusion(s) were excluded from analysis. Number analyzed is the number of participants with Hb concentration assessment at specified time points. | Posted | Number | participants | Week 17 up to Week 21 |
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| ||||||||||||||||||||||||||||||||||
| Secondary | Mean Hb Values and Change From Baseline | The mean Hb concentration over time and the mean change in Hb from baseline over time are presented. | ITT population included all participants enrolled in the study. Number analyzed signifies number of participants evaluable at specified time points. | Posted | Mean | Standard Deviation | g/dL | Baseline, Weeks 3, 5, 9, 13, 17, 19, 21, 25, 29, 33, 37, 41, 45 |
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| Secondary | Change in Mircera Dose Over Time | A dose change was defined as a change in the administered dose strength compared to the preceding dose. | Safety population included all participants who received at least one dose of study drug regardless of whether they withdrew prematurely or not. Number analyzed signifies number of participants evaluable at specified time points. | Posted | Median | Full Range | micrograms (µg) | Week 1 to Week 17 |
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| Secondary | Ratio of Mircera Starting Dose (Week 1) to the Dose at Week 17 | The ratio of Mircera dose was calculated as the median (min-max) ratio of starting dose (Week 1) to the dose at Week 17. Participants who withdrew before Week 17 or who were not administered a Mircera dose at Week 17 visit due to the applicable dose adjustment rules were excluded from the ratio computation. | Participants who received a dose of study drug on Week 1 and Week 17 were included in the analysis. | Posted | Median | Full Range | ratio | Week 1, Week 17 |
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| Secondary | Number of Participants With Adverse Events by Severity as Assessed by Highest World Health Organization (WHO) Toxicity Grade | An adverse event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product, any new disease, or exacerbation of existing disease (a worsening in the character, frequency, or severity of a known condition), recurrence of an intermittent medical condition or any deterioration in a laboratory value or other clinical test. | Safety population included all participants who received at least one dose of study drug regardless of whether they withdrew prematurely or not. | Posted | Number | participants | Baseline up to Week 45 |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Bioavailability (F) of Mircera in Pediatric Participants Based on Population PK Model | Bioavailability (F) is defined as the percentage of the administered drug, that reaches the systemic circulation. A population PK model was developed for Mircera that adequately describes pediatric data: a 1-compartment model with first order absorption and elimination processes. The bioavailability (F) was estimated using all the data points listed under time frame using the population PK model. | PK population included all participants enrolled in the study. | Posted | Number | percentage | Pre-dose at Week 1, 9, 17; Post-dose at Week 3, Week 19 and additional sample taken between 24 hours and 5 days at participant's convenience |
|
|
Up to Week 45
Safety population included all participants who received at least one dose of study drug regardless of whether they withdrew prematurely or not.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mircera | Mircera was administered subcutaneously once every 4 weeks. | 0 | 40 | 13 | 40 | 28 | 40 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hydrocele | Congenital, familial and genetic disorders | MedDRA 24.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Device related thrombosis | General disorders | MedDRA 24.0 | Systematic Assessment |
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| Appendicitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Device related infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Enterovirus infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Peritonitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Pharyngotonsillitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Pyelonephritis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Respiratory syncytial virus bronchiolitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Rhinovirus infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Viral infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Anaemia postoperative | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
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| Device malfunction | Product Issues | MedDRA 24.0 | Systematic Assessment |
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| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Injection site pain | General disorders | MedDRA 24.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 24.0 | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Conjunctivitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Pharyngitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Rhinitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Accidental overdose | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
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| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
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| Hyperphosphataemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
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| Haematuria | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
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The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800 821-8590 | genentech@druginfo.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 4, 2021 | Jan 18, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000740 | Anemia |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| 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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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Title | Denominators | Categories | ||||
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| Baseline |
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| Week 45 |
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