Not provided
Not provided
Not provided
Not provided
Not provided
Strategic decision unrelated to safety or efficacy
Not provided
Not provided
Not provided
Not provided
Not provided
This study will assess the efficacy and safety of methoxy polyethylene glycol-epoetin beta (Mircera) in the maintenance of hemoglobin levels in patients who have previously received treatment with epoetin alfa or darbepoetin alfa, and who are transitioning from chronic kidney disease stage 4 through dialysis. Patients will be randomized either to receive Mircera or to remain on their existing therapy; the initial monthly dose of subcutaneous (sc) Mircera (120-360 micrograms) will be based on the average weekly dose of epoetin alfa or darbepoetin alfa administered in the week preceding the switch to Mircera. At the initiation of dialysis, patients in the Mircera group will receive monthly intravenous (iv) Mircera at a starting dose based on their previous (sc) dose, and those in the control group will receive weekly (iv) epoetin alfa. The anticipated time on study treatment is 1-2 years, and the target sample size is 500+ individuals.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| methoxy polyethylene glycol-epoetin beta | Experimental | 120-360 micrograms methoxy polyethylene glycol-epoetin beta subcutaneous (sc) monthly starting dose, for a minimum of 5 months to a maximum of 18 months. Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL. |
|
| Epoetin alfa | Active Comparator | Patients randomized to the reference arm continued to receive their standard of care dose and regimen of epoetin alfa subcutaneous once per week for a minimum of 5 months to a maximum of 18 months. Subcutaneous injections were to be administered in the same part of the body (ie, thigh, abdomen or arm) throughout the study. Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL. |
|
| Darbepoetin alfa | Active Comparator | Patients randomized to the reference arm continued to receive their standard of care dose and regimen of darbepoetin subcutaneous once every two weeks for a minimum of 5 months and a maximum of 18 months. Subcutaneous injections were to be administered in the same part of the body (ie, thigh, abdomen or arm) throughout the study. Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| methoxy polyethylene glycol-epoetin beta | Drug | Methoxy polyethylene glycol-epoetin beta was provided as a sterile single-use injectable solution in a 1-mL prefilled syringe containing 0.3 mL or 0.6 mL solution. The methoxy polyethylene glycol-epoetin beta injectable solution was formulated in sodium phosphate, sodium sulfate, mannitol, methionine and poloxamer 188, pH 6.2 and did not contain any preservative. Participants received methoxy polyethylene glycol-epoetin beta subcutaneous once a month. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients Able to Maintain Hemoglobin (Hb) Within 10-12 g/dL | Efficacy analyses were not performed. | 6-7 months post initiation of dialysis |
| Measure | Description | Time Frame |
|---|---|---|
| Dose Adjustments | Efficacy analyses were not performed. | 5 months post-randomization through onset of dialysis, and post-dialysis initiation through study end. |
| Number of Participants Assessed for AEs and SAEs |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | United States | ||||
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Methoxy Polyethylene Glycol-epoetin Beta | 120-360 micrograms methoxy polyethylene glycol-epoetin beta subcutaneous (sc) monthly starting dose, for a minimum of 5 months to a maximum of 18 months. Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| epoetin alfa | Drug | Standard of care as prescribed, per individual participant, subcutaneous once per week. Subcutaneous injections were to be administered in the same part of the body (ie, thigh, abdomen or arm) throughout the study. |
|
| darbepoetin alfa | Drug | Standard of care as prescribed, per individual participant, darbepoetin alfa subcutaneous once every two weeks. Subcutaneous injections were to be administered in the same part of the body (ie, thigh,abdomen or arm) throughout the study. |
|
The adverse events are captured in the adverse event and serious adverse event section of this database.
| First dose of medication through 15 days post last dose (up to 8 months) |
| Mobile |
| Alabama |
| United States |
| Phoenix | Arizona | United States |
| El Dorado | Arkansas | United States |
| Hot Springs | Arkansas | United States |
| Bakersfield | California | United States |
| Glendale | California | United States |
| Granada Hills | California | 91344 | United States |
| Los Angeles | California | United States |
| Orange | California | United States |
| Palm Springs | California | United States |
| Riverside | California | United States |
| San Diego | California | United States |
| Yuba City | California | United States |
| Colorado Springs | Colorado | United States |
| Lakewood | Colorado | United States |
| Stamford | Connecticut | United States |
| Miami | Florida | United States |
| Ocala | Florida | United States |
| Orlando | Florida | United States |
| Palm Beach Gardens | Florida | United States |
| Pembroke Pines | Florida | United States |
| Tampa | Florida | United States |
| Atlanta | Georgia | United States |
| Augusta | Georgia | United States |
| Macon | Georgia | United States |
| Meridan | Idaho | 83642 | United States |
| Evergreen Park | Illinois | United States |
| Fort Wayne | Indiana | United States |
| Wichita | Kansas | United States |
| Baton Rouge | Louisiana | United States |
| Shreveport | Louisiana | United States |
| Germantown | Maryland | United States |
| Boston | Massachusetts | United States |
| Springfield | Massachusetts | United States |
| Detroit | Michigan | United States |
| Milwaukee | Michigan | United States |
| Royal Oak | Michigan | United States |
| Columbus | Mississippi | United States |
| St Louis | Missouri | United States |
| Omaha | Nebraska | United States |
| Voorhees Township | New Jersey | United States |
| West Orange | New Jersey | 07052 | United States |
| Brooklyn | New York | United States |
| Buffalo | New York | United States |
| Flushing | New York | United States |
| Great Neck | New York | United States |
| Mineola | New York | United States |
| Springfield Gardens | New York | United States |
| Syracuse | New York | United States |
| The Bronx | New York | United States |
| Durham | North Carolina | United States |
| Greenville | North Carolina | United States |
| Raleigh | North Carolina | United States |
| Winston-Salem | North Carolina | United States |
| Maimisburg | Ohio | United States |
| Toledo | Ohio | United States |
| Portland | Oregon | United States |
| Erie | Pennsylvania | United States |
| Lewistown | Pennsylvania | United States |
| Philadelphia | Pennsylvania | United States |
| Pittsburgh | Pennsylvania | United States |
| Providence | Rhode Island | United States |
| Columbia | South Carolina | United States |
| Greenville | South Carolina | United States |
| Orangeburg | South Carolina | United States |
| Chattanooga | Tennessee | United States |
| Dyersburg | Tennessee | United States |
| Houston | Texas | 77024 | United States |
| San Antonio | Texas | United States |
| Temple | Texas | United States |
| Alexandria | Virginia | United States |
| Fairfax | Virginia | United States |
| Richmond | Virginia | United States |
| Salem | Virginia | United States |
| Bluefield | West Virginia | United States |
| Morgantown | West Virginia | United States |
| Appleton | Wisconsin | United States |
| Epoetin Alfa |
Patients randomized to the reference arm continued to receive their standard of care dose and regimen of epoetin alfa subcutaneous once per week for a minimum of 5 months to a maximum of 18 months. Subcutaneous injections were to be administered in the same part of the body (ie, thigh, abdomen or arm) throughout the study. Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL. |
| FG002 | Darbepoetin Alfa | Patients randomized to the reference arm continued to receive their standard of care dose and regimen of darbepoetin subcutaneous once every two weeks for a minimum of 5 months and a maximum of 18 months. Subcutaneous injections were to be administered in the same part of the body (ie, thigh, abdomen or arm) throughout the study. Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Methoxy Polyethylene Glycol-epoetin Beta | 120-360 micrograms methoxy polyethylene glycol-epoetin beta subcutaneous (sc) monthly starting dose, for a minimum of 5 months to a maximum of 18 months. Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL. |
| BG001 | Epoetin Alfa | Patients randomized to the reference arm continued to receive their standard of care dose and regimen of epoetin alfa subcutaneous once per week for a minimum of 5 months to a maximum of 18 months. Subcutaneous injections were to be administered in the same part of the body (ie, thigh, abdomen or arm) throughout the study. Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL. |
| BG002 | Darbepoetin Alfa | Patients randomized to the reference arm continued to receive their standard of care dose and regimen of darbepoetin subcutaneous once every two weeks for a minimum of 5 months and a maximum of 18 months. Subcutaneous injections were to be administered in the same part of the body (ie, thigh, abdomen or arm) throughout the study. Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | There were four (4) patients who did not receive at least one dose of study medication in the methoxy polyethylene glycol-epoetin beta group and three (3) in the Epoetin Alfa group. | Mean | Standard Deviation | years |
| ||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 Patients Able to Maintain Hemoglobin (Hb) Within 10-12 g/dL | Efficacy analyses were not performed. | Posted | Number | percentage of participants | 6-7 months post initiation of dialysis |
|
| ||||||||||||||||||||||||
| Secondary | Dose Adjustments | Efficacy analyses were not performed. | Posted | Number | participants | 5 months post-randomization through onset of dialysis, and post-dialysis initiation through study end. |
| |||||||||||||||||||||||||
| Secondary | Number of Participants Assessed for AEs and SAEs | The adverse events are captured in the adverse event and serious adverse event section of this database. | Safety Population | Posted | Number | participants | First dose of medication through 15 days post last dose (up to 8 months) |
|
First dose of medication through 15 days post last dose (up to 8 months)
The safety population is the population that received at least one dose of drug. Four patients in the methoxy polyethylene glycol-epoetin beta group and 3 patients in the Epoetin Alfa group did not receive at least one dose of drug.
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 | Methoxy Polyethylene Glycol-epoetin Beta | 120-360 micrograms methoxy polyethylene glycol-epoetin beta subcutaneous (sc) monthly starting dose, for a minimum of 5 months to a maximum of 18 months. Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL. | 7 | 69 | 13 | 69 | ||
| EG001 | Epoetin Alfa | Patients randomized to the reference arm continued to receive their standard of care dose and regimen of epoetin alfa subcutaneous once per week for a minimum of 5 months to a maximum of 18 months. Subcutaneous injections were to be administered in the same part of the body (ie, thigh, abdomen or arm) throughout the study. Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL. | 4 | 26 | 7 | 26 | ||
| EG002 | Darbepoetin Alfa | Patients randomized to the reference arm continued to receive their standard of care dose and regimen of darbepoetin subcutaneous once every two weeks for a minimum of 5 months and a maximum of 18 months. Subcutaneous injections were to be administered in the same part of the body (ie, thigh, abdomen or arm) throughout the study. Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL. | 1 | 9 | 3 | 9 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| atrial flutter | Cardiac disorders | MedDRA (10.1) | Systematic Assessment |
| |
| cardiac failure congestive | Cardiac disorders | MEDRA 10.1 | Systematic Assessment |
| |
| diabetic gastroparesis | Gastrointestinal disorders | MEDRA 10.1 | Systematic Assessment |
| |
| peptic ulcer perforation | Gastrointestinal disorders | MEDRA 10.1 | Systematic Assessment |
| |
| hip fracture | Injury, poisoning and procedural complications | MEDRA 10.1 | Systematic Assessment |
| |
| sternal fracture | Injury, poisoning and procedural complications | MEDRA 10.1 | Systematic Assessment |
| |
| cholecystitis acute | Hepatobiliary disorders | MEDRA 10.1 | Systematic Assessment |
| |
| catheter related infection | Infections and infestations | MEDRA 10.1 | Systematic Assessment |
| |
| cellulitis | Infections and infestations | MEDRA 10.1 | Systematic Assessment |
| |
| anticoagulation drug level above therapeutic | Investigations | MEDRA 10.1 | Systematic Assessment |
| |
| hypoglycaemia | Metabolism and nutrition disorders | MEDRA 10.1 | Systematic Assessment |
| |
| musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MEDRA 10.1 | Systematic Assessment |
| |
| mental status changes | Psychiatric disorders | MEDRA 10.1 | Systematic Assessment |
| |
| renal impairment | Renal and urinary disorders | MEDRA 10.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| urinary tract infection | Renal and urinary disorders | MEDRA 10.1 | Systematic Assessment |
| |
| diarrhoea | Gastrointestinal disorders | MEDRA 10.1 | Systematic Assessment |
| |
| oedema peripheral | General disorders | MEDRA 10.1 | Systematic Assessment |
| |
| fatigue | General disorders | MEDRA 10.1 | Systematic Assessment |
| |
| hyperkalaemia | Metabolism and nutrition disorders | MEDRA 10.1 | Systematic Assessment |
| |
| nausea | Gastrointestinal disorders | MEDRA 10.1 | Systematic Assessment |
| |
| skin laceration | Skin and subcutaneous tissue disorders | MEDRA 10.1 | Systematic Assessment |
| |
| dizziness | Nervous system disorders | MEDRA 10.1 | Systematic Assessment |
| |
| dyspnoea | Respiratory, thoracic and mediastinal disorders | MEDRA 10.1 | Systematic Assessment |
| |
| ascites | General disorders | MEDRA 10.1 | Systematic Assessment |
| |
| bradycardia | Cardiac disorders | MEDRA 10.1 | Systematic Assessment |
| |
| depression | Psychiatric disorders | MEDRA 10.1 | Systematic Assessment |
| |
| diverticulum | Gastrointestinal disorders | MEDRA 10.1 | Systematic Assessment |
| |
| hypotension | Vascular disorders | MEDRA 10.1 | 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 | Hoffman-LaRoche | 800-821-8590 |
| 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 |
| D000068817 | Epoetin Alfa |
| D000068256 | Darbepoetin alfa |
| ID | Term |
|---|---|
| D004921 | Erythropoietin |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
Not provided
Not provided
| Male |
|
|
|
|