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This 2 arm study will compare the efficacy and safety of Mircera and darbepoetin alfa in the treatment of anemia in patients with chronic kidney disease who are not on dialysis and who are receiving subcutaneous darbepoetin alfa maintenance therapy. Patients will be randomized either to remain on darbepoetin alfa therapy as per local label, or to switch to monthly subcutaneous Mircera, at a starting dose of 120, 200 or 360 micrograms, depending on the weekly dose of darbepoetin alfa administered prior to the first dose of Mircera. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mircera | Experimental | Participants received Mircera by subcutaneous injection once every month during the dose titration (7 months) and evaluation period (2 months). The starting dose was based on the weekly dose of darbepoetin alfa administered prior to the switch to Mircera, and was either 120, 200 or 360 µg Mircera per month. The dose was then adjusted to maintain Hemoglobin levels within the defined target range and also according to the need for red blood cell transfusions (due to worsening anemia), or for toxicity related to Mircera. |
|
| Darbepoetin alfa | Active Comparator | Participants continued to receive the same dose of darbepoetin alfa as before screening by subcutaneous injection once every week, once every 2 weeks or once every month as per local labeling during the dose titration (7 months) and the evaluation period (2 months). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mircera | Drug | Starting dose of 120, 200 and 360 micrograms administered by subcutaneous injection once a month. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hemoglobin (Hb) Concentration From Baseline to the Evaluation Period | A time adjusted average baseline hemoglobin (Hb) concentration was calculated using the trapezoid rule from all available Hb measurements taken during the baseline period. The average evaluation period Hb concentration for each individual was calculated using the same method, from all their available measurements taken during the two month evaluation period. The change in Hb concentration between the baseline and evaluation periods was calculated by subtracting the baseline Hb from the evaluation period Hb. All blood samples for Hb measurements were taken prior to study drug administration. | Baseline (measurements at Week -4, Week -2 and Day 1) and Evaluation Period (Months 8 and 9; measurements twice a month and at the final visit). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hemoglobin Concentration From Baseline Over Time | From Baseline to 9 months; blood samples for hemoglobin measurements were taken twice a month, at each study visit. | |
| Number of Participants With Red Blood Cell (RBC) Transfusions | Red blood cell (RBC) transfusions could be given during the treatment period in case of medical need, i.e., in severely anemic patients with recognized symptoms or signs of anemia (e.g., in patients with acute blood loss, with severe angina, or whose Hemoglobin decreased to critical levels). The number of participants who had at least one red blood cell transfusion during the entire study, during the Titration Period and during the Evaluation Period is presented. Participants who received more than one transfusion within a defined period are only counted once. |
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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 |
|---|---|---|---|---|---|---|
| Granada Hills | California | 91344 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36791280 | Derived | Chung EY, Palmer SC, Saglimbene VM, Craig JC, Tonelli M, Strippoli GF. Erythropoiesis-stimulating agents for anaemia in adults with chronic kidney disease: a network meta-analysis. Cochrane Database Syst Rev. 2023 Feb 13;2(2):CD010590. doi: 10.1002/14651858.CD010590.pub3. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Mircera | Participants received Mircera by subcutaneous injection once every month during the dose titration (7 months) and evaluation period (2 months). The starting dose was based on the weekly dose of darbepoetin alfa administered prior to the switch to Mircera, and was either 120, 200 or 360 µg Mircera per month. The dose was then adjusted to maintain Hemoglobin levels within the defined target range and also according to the need for red blood cell transfusions (due to worsening anemia), or for toxicity related to Mircera. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Titration Period |
|
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| Darbepoetin alfa | Drug | As prescribed, subcutaneous injection once every week, once every 2 weeks or once every month as per local labeling specifications. |
|
|
| From randomization to Month 9 |
| Participants With Adverse Events | Adverse events were collected during the treatment period (from the first treatment dose) up to 30 days after last dose or at least until the date of last contact if the date of last contact occurred after the specified 30 day period. | Randomization to Month 10 (final visit) |
| Lauderdale Lakes |
| Florida |
| 33313 |
| United States |
| Augusta | Georgia | 30309 | United States |
| Mineola | New York | 11501 | United States |
| Orchard Park | New York | 14127 | United States |
| Raleigh | North Carolina | 27609 | United States |
| Oregon City | Oregon | 97045 | United States |
| Providence | Rhode Island | 02903 | United States |
| Chattanooga | Tennessee | 37404 | United States |
| Salem | Virginia | 24153 | United States |
| Morgantown | West Virginia | 26506 | United States |
| Adelaide | SA 5000 | Australia |
| Gosford | 2250 | Australia |
| Lismore | 2480 | Australia |
| Reservoir | 3073 | Australia |
| Richmond | 3121 | Australia |
| Aalst | 9300 | Belgium |
| Roeselare | 8800 | Belgium |
| Calgary | Alberta | T2N 2T9 | Canada |
| St. John's | Newfoundland and Labrador | A1B 3V6 | Canada |
| Kingston | Ontario | K7L 3N6 | Canada |
| Mississauga | Ontario | L5M 2V8 | Canada |
| Toronto | Ontario | M5G 2C4 | Canada |
| Toronto | Ontario | M9N 1N8 | Canada |
| Montreal | Quebec | H2X 3J4 | Canada |
| Mariánské Lázně | 35301 | Czechia |
| Prague | 128 08 | Czechia |
| Prague | 14021 | Czechia |
| Prague | 14200 | Czechia |
| La Tronche | 38700 | France |
| Nantes | 44035 | France |
| Orléans | 45100 | France |
| Paris | 75475 | France |
| Rennes | 35033 | France |
| Saint-Priest-en-Jarez | 42277 | France |
| Strasbourg | 67091 | France |
| Bad Hersfeld | 36251 | Germany |
| Bad König | 64732 | Germany |
| Berlin | 13353 | Germany |
| Bonn | 53127 | Germany |
| Coburg | 96450 | Germany |
| Demmin | 17109 | Germany |
| Dortmund | 44263 | Germany |
| München | 80331 | Germany |
| Baja | 6500 | Hungary |
| Budapest | 1071 | Hungary |
| Esztergom | 2500 | Hungary |
| Hódmezővásárhely | 6800 | Hungary |
| Kalocsa | 6300 | Hungary |
| Kecskemét | 6001 | Hungary |
| Szigetvár | 7390 | Hungary |
| Vác | 2600 | Hungary |
| Hadera | 38100 | Israel |
| Jerusalem | 91031 | Israel |
| Kfar Saba | 44281 | Israel |
| Nahariya | 22100 | Israel |
| Rehovot | 76100 | Israel |
| Brescia | 25123 | Italy |
| Chieti | 66013 | Italy |
| Ferrara | 44100 | Italy |
| Genova | 16132 | Italy |
| La Spezia | 19124 | Italy |
| Lecco | 23900 | Italy |
| Lodi | 26900 | Italy |
| Palermo | 90127 | Italy |
| Pavia | 27100 | Italy |
| Prato | 50047 | Italy |
| Roma | 00186 | Italy |
| S Fermo Della Battaglia | 22020 | Italy |
| Gdansk | 80-211 | Poland |
| Katowice | 40-027 | Poland |
| Lodz | 90-153 | Poland |
| Radom | 20-610 | Poland |
| Rzeszów | 35-055 | Poland |
| Sieradz | 98-200 | Poland |
| Szczecin | 70-111 | Poland |
| Warsaw | 02-006 | Poland |
| A Coruña | 15006 | Spain |
| Barcelona | 08025 | Spain |
| Barcelona | 08035 | Spain |
| Barcelona | 08036 | Spain |
| Ciudad Real | 13005 | Spain |
| L'Hospitalet de Llobregat | 08907 | Spain |
| Lleida | 25198 | Spain |
| Madrid | 28007 | Spain |
| Málaga | 29010 | Spain |
| Partida La Ceñuela. Torreviej | 03186 | Spain |
| Belfast | BT9 7LJ | United Kingdom |
| Birmingham | B15 2TH | United Kingdom |
| Bradford | BD5 0NA | United Kingdom |
| Exeter | EX2 5DW | United Kingdom |
| FG001 | Darbepoetin Alfa | Participants continued to receive the same dose of darbepoetin alfa by subcutaneous injection once every week, once every 2 weeks or once every month as per local labeling during the dose titration (7 months) and the evaluation period (2 months). |
| Safety Population |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Evaluation Period |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Mircera | Participants received Mircera by subcutaneous injection once every month during the dose titration (7 months) and evaluation period (2 months). The starting dose was based on the weekly dose of darbepoetin alfa administered prior to the switch to Mircera, and was either 120, 200 or 360 µg Mircera per month. The dose was then adjusted to maintain Hemoglobin levels within the defined target range and also according to the need for red blood cell transfusions (due to worsening anemia), or for toxicity related to Mircera. |
| BG001 | Darbepoetin Alfa | Participants continued to receive the same dose of darbepoetin alfa by subcutaneous injection once every week, once every 2 weeks or once every month as per local labeling during the dose titration (7 months) and the evaluation period (2 months). |
| BG002 | 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 | 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 | Change in Hemoglobin (Hb) Concentration From Baseline to the Evaluation Period | A time adjusted average baseline hemoglobin (Hb) concentration was calculated using the trapezoid rule from all available Hb measurements taken during the baseline period. The average evaluation period Hb concentration for each individual was calculated using the same method, from all their available measurements taken during the two month evaluation period. The change in Hb concentration between the baseline and evaluation periods was calculated by subtracting the baseline Hb from the evaluation period Hb. All blood samples for Hb measurements were taken prior to study drug administration. | Per Protocol population consisted of all randomized patients who had received at least one dose of trial medication and who have no major protocol violation. Data missing at the end of the evaluation period were handled using the last observation carried forward method (LOCF). | Posted | Mean | Standard Deviation | g/dL | Baseline (measurements at Week -4, Week -2 and Day 1) and Evaluation Period (Months 8 and 9; measurements twice a month and at the final visit). |
|
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Change in Hemoglobin Concentration From Baseline Over Time | Intent-to-treat population, including all randomized patients. "n" refers to the number of patients for whom data was available at each time point. | Posted | Mean | Standard Deviation | g/dL | From Baseline to 9 months; blood samples for hemoglobin measurements were taken twice a month, at each study visit. |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Red Blood Cell (RBC) Transfusions | Red blood cell (RBC) transfusions could be given during the treatment period in case of medical need, i.e., in severely anemic patients with recognized symptoms or signs of anemia (e.g., in patients with acute blood loss, with severe angina, or whose Hemoglobin decreased to critical levels). The number of participants who had at least one red blood cell transfusion during the entire study, during the Titration Period and during the Evaluation Period is presented. Participants who received more than one transfusion within a defined period are only counted once. | Safety population included all randomized patients who received at least one dose of trial medication and a safety follow-up, according to the treatment received. | Posted | Number | participants | From randomization to Month 9 |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Participants With Adverse Events | Adverse events were collected during the treatment period (from the first treatment dose) up to 30 days after last dose or at least until the date of last contact if the date of last contact occurred after the specified 30 day period. | Safety population | Posted | Number | participants | Randomization to Month 10 (final visit) |
|
|
All adverse events that occurred from the first treatment dose were summarized. Adverse events were included up to 30 days after last dose or at least until the date of last contact if the date of last contact occurred after the specified 30 day period.
Safety population was used for analysis.
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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 | Participants received Mircera by subcutaneous injection once every month during the dose titration (7 months) and evaluation period (2 months). The starting dose was based on the weekly dose of darbepoetin alfa administered prior to the switch to Mircera, and was either 120, 200 or 360 µg Mircera per month. The dose was then adjusted to maintain Hemoglobin levels within the defined target range and also according to the need for red blood cell transfusions (due to worsening anemia), or for toxicity related to Mircera. | 41 | 115 | 59 | 115 | ||
| EG001 | Darbepoetin Alfa | Participants continued to receive the same dose of darbepoetin alfa by subcutaneous injection once every week, once every 2 weeks or once every month as per local labeling during the dose titration (7 months) and the evaluation period (2 months). | 23 | 113 | 49 | 113 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| CARDIAC FAILURE CONGESTIVE | Cardiac disorders | MedDRA (13.0) | Systematic Assessment |
| |
| ATRIAL FIBRILLATION | Cardiac disorders | MedDRA (13.0) | Systematic Assessment |
| |
| ACUTE MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA (13.0) | Systematic Assessment |
| |
| AORTIC VALVE DISEASE MIXED | Cardiac disorders | MedDRA (13.0) | Systematic Assessment |
| |
| ARRHYTHMIA | Cardiac disorders | MedDRA (13.0) | Systematic Assessment |
| |
| ATRIAL FLUTTER | Cardiac disorders | MedDRA (13.0) | Systematic Assessment |
| |
| BRADYCARDIA | Cardiac disorders | MedDRA (13.0) | Systematic Assessment |
| |
| CARDIAC FAILURE | Cardiac disorders | MedDRA (13.0) | Systematic Assessment |
| |
| CARDIOGENIC SHOCK | Cardiac disorders | MedDRA (13.0) | Systematic Assessment |
| |
| CORONARY ARTERY DISEASE | Cardiac disorders | MedDRA (13.0) | Systematic Assessment |
| |
| MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA (13.0) | Systematic Assessment |
| |
| MYOCARDIAL ISCHAEMIA | Cardiac disorders | MedDRA (13.0) | Systematic Assessment |
| |
| SICK SINUS SYNDROME | Cardiac disorders | MedDRA (13.0) | Systematic Assessment |
| |
| SILENT MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA (13.0) | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| BRONCHOPNEUMONIA | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| CORYNEBACTERIUM SEPSIS | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| GASTROENTERITIS | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| INFECTED SKIN ULCER | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| NEUROLOGICAL INFECTION | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| OSTEOMYELITIS | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| POST PROCEDURAL INFECTION | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| FLUID OVERLOAD | Metabolism and nutrition disorders | MedDRA (13.0) | Systematic Assessment |
| |
| HYPERKALAEMIA | Metabolism and nutrition disorders | MedDRA (13.0) | Systematic Assessment |
| |
| DEHYDRATION | Metabolism and nutrition disorders | MedDRA (13.0) | Systematic Assessment |
| |
| DIABETES MELLITUS INADEQUATE CONTROL | Metabolism and nutrition disorders | MedDRA (13.0) | Systematic Assessment |
| |
| FLUID RETENTION | Metabolism and nutrition disorders | MedDRA (13.0) | Systematic Assessment |
| |
| HYPOGLYCAEMIA | Metabolism and nutrition disorders | MedDRA (13.0) | Systematic Assessment |
| |
| HYPONATRAEMIA | Metabolism and nutrition disorders | MedDRA (13.0) | Systematic Assessment |
| |
| CEREBROVASCULAR ACCIDENT | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| ATAXIA | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| NERVE ROOT COMPRESSION | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| PARTIAL SEIZURES | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| SCIATICA | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| TRANSIENT ISCHAEMIC ATTACK | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| VERTEBROBASILAR INSUFFICIENCY | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| RENAL IMPAIRMENT | Renal and urinary disorders | MedDRA (13.0) | Systematic Assessment |
| |
| RENAL FAILURE CHRONIC | Renal and urinary disorders | MedDRA (13.0) | Systematic Assessment |
| |
| CALCULUS URETERIC | Renal and urinary disorders | MedDRA (13.0) | Systematic Assessment |
| |
| PANCREATITIS ACUTE | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| COLITIS ISCHAEMIC | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| GASTROINTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| HIATUS HERNIA | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| RECTAL POLYP | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| LOWER LIMB FRACTURE | Injury, poisoning and procedural complications | MedDRA (13.0) | Systematic Assessment |
| |
| FEMORAL NECK FRACTURE | Injury, poisoning and procedural complications | MedDRA (13.0) | Systematic Assessment |
| |
| PELVIC FRACTURE | Injury, poisoning and procedural complications | MedDRA (13.0) | Systematic Assessment |
| |
| VERTIGO | Ear and labyrinth disorders | MedDRA (13.0) | Systematic Assessment |
| |
| ANGIOSARCOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | Systematic Assessment |
| |
| BASAL CELL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | Systematic Assessment |
| |
| COLON CANCER METASTATIC | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | Systematic Assessment |
| |
| ARTERIOSCLEROSIS | Vascular disorders | MedDRA (13.0) | Systematic Assessment |
| |
| EXTREMITY NECROSIS | Vascular disorders | MedDRA (13.0) | Systematic Assessment |
| |
| HYPERTENSION | Vascular disorders | MedDRA (13.0) | Systematic Assessment |
| |
| NON-CARDIAC CHEST PAIN | General disorders | MedDRA (13.0) | Systematic Assessment |
| |
| OEDEMA PERIPHERAL | General disorders | MedDRA (13.0) | Systematic Assessment |
| |
| CHOLECYSTITIS | Hepatobiliary disorders | MedDRA (13.0) | Systematic Assessment |
| |
| CHOLELITHIASIS | Hepatobiliary disorders | MedDRA (13.0) | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| PATHOLOGICAL FRACTURE | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| ASTHMA | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| CHRONIC OBSTRUCTIVE PULMONARY DISEASE | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| SKIN ULCER | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| NEPHROGENIC ANAEMIA | Blood and lymphatic system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| CATARACT | Eye disorders | MedDRA (13.0) | Systematic Assessment |
| |
| BENIGN PROSTATIC HYPERPLASIA | Reproductive system and breast disorders | MedDRA (13.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| HYPERTENSION | Vascular disorders | MedDRA (13.0) | Systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| RENAL IMPAIRMENT | Renal and urinary disorders | MedDRA (13.0) | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| OEDEMA DUE TO RENAL DISEASE | General disorders | MedDRA (13.0) | Systematic Assessment |
| |
| HYPERPARATHYROIDISM SECONDARY | Endocrine disorders | MedDRA (13.0) | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | 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 |
| D000068256 | Darbepoetin alfa |
| ID | Term |
|---|---|
| D004921 | Erythropoietin |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
Not provided
Not provided
| Insufficient Therapeutic Response |
|
| Refused treatment |
|
| Renal transplant |
|
| Failure to return |
|
| Site closure |
|
| Male |
|
| Participants |
|
|
|
|
| Counts |
|---|
| Participants |
|
|