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This 2 arm study will evaluate the efficacy of intravenous Mircera treatment for the correction of anemia in patients with chronic kidney disease who are on dialysis. Patients will be randomized to receive either Mircera 0.6 micrograms/kg i.v. every 2 weeks, or epoetin 3 times per week i.v. according to approved treatment recommendations. 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 |
|---|---|---|---|
| Correction Phase: CERA | Experimental |
| |
| Correction Phase: Epoetin Beta | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| methoxy polyethylene glycol-epoetin beta [RO0503821, Mircera] | Drug | 0.6 micrograms/kg every 2 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieved Hemoglobin Response up to Week 24 | Hemoglobin (Hb) response was defined as increase of Hb by at least 1 g/dL compared with baseline and Hb>/=11 g/dL without red blood cell transfusion during 24-week correction phase. The average baseline value was estimated by the mean of all values recorded between the day of first study dose and the previous 20 days. The percentage of participants who achieved Hb response is presented | Up to Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Hemoglobin Concentration at Week 24 | Mean hemoglobin levels and their changes in correction phase from baseline were presented. Baseline is defined as Day 1 visit. The mean Hb concentration from Baseline at week 24 was calculated by subtracting the baseline Hb concentration value from the week 24 value | From Baseline (Day 1) to Week 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 |
|---|---|---|---|---|---|---|
| Gyeonggi-do | 431-070 | South Korea | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24431909 | Derived | Oh J, Joo KW, Chin HJ, Chae DW, Kim SG, Kim SJ, Chung W, Kim S, Huh W, Oh HY, Choi BS, Yang CW, Kim S. Correction of anemia with continuous erythropoietin receptor activator in Korean patients on long-term hemodialysis. J Korean Med Sci. 2014 Jan;29(1):76-83. doi: 10.3346/jkms.2014.29.1.76. Epub 2013 Dec 26. |
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A total of 80 participants were enrolled in this study conducted from 05 November 2007 to 23 December 2009 at 7 centers in Korea.
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| ID | Title | Description |
|---|---|---|
| FG000 | Correction Phase: CERA | Eligible participants were administered CERA IV once every 2 weeks at the starting dose of 0.6 μg/kg for 24 weeks. |
| FG001 | Correction Phase: Epoetin Beta | Eligible participants were administered Epoetin beta IV three times per week at the starting dose of 40 IU/kg for 24 weeks. |
| FG002 | Maintenance Phase: CERA | Eligible participants who achieved a hemoglobin target range of level >=11.0 g/dL at least once during the correction phase (Week 1 to Week 24) without RBC transfusion and completed correction phase treatment, moved to Maintenance phase wherein they were administered CERA (dose adjusted according to the predefined criteria in protocol) IV once every 4 weeks for the subsequent 24 weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Correction Phase (CERA or Epoetin Beta) |
|
| |||||||||||||||||||||
| Maintenance Phase (CERA) |
|
The Intent-to-Treat (ITT) population included all randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Correction Phase: CERA | Eligible participants were administered CERA IV once every 2 weeks at the starting dose of 0.6 μg/kg for 24 weeks. |
| BG001 | Correction Phase: Epoetin Beta |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Who Achieved Hemoglobin Response up to Week 24 | Hemoglobin (Hb) response was defined as increase of Hb by at least 1 g/dL compared with baseline and Hb>/=11 g/dL without red blood cell transfusion during 24-week correction phase. The average baseline value was estimated by the mean of all values recorded between the day of first study dose and the previous 20 days. The percentage of participants who achieved Hb response is presented | The Intent-to-Treat population included all randomized participants. | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to Week 24 |
|
Up to Week 49
All participants who received at least one dose of the study medication and had a safety follow-up, whether withdrawn prematurely or not, included in the Safety Population. One participant from CERA group and two participants from Epoetin Beta group did not receive any study medication and were excluded from the safety 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 | Correction Phase: CERA | Eligible participants were administered CERA IV once every 2 weeks at the starting dose of 0.6 μg/kg for 24 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Supraventricular tachycardia | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA (12.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Roche Trial Information Hotline | F. Hoffmann-La Roche AG | +41 616878333 | global.trial_information@roche.com |
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| ID | Term |
|---|---|
| D000740 | Anemia |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C508420 | continuous erythropoietin receptor activator |
| D004921 | Erythropoietin |
| ID | Term |
|---|---|
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
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| Epoetin | Drug | As prescribed, iv, 3 times weekly |
|
| Median Time in Which Hemoglobin Value Was Maintained Within Target Range of >/= 11g/dL up to Week 24 | Median time during the correction period in which Hb value was maintained within target range of >/= 11.0 g/dL and an increase in hemoglobin from baseline >/= 1.0 g/dL was reported. | Up to Week 24 |
| Number of Participants Who Received Red Blood Cells Transfusions up to Week 49 | The number of participants who received at least 1 red blood cell transfusion during the study is presented. RBC transfusions was given in case of medical need, i.e., in severely anemic participants with recognized symptoms or signs of anemia (e.g., in participants with acute blood loss, with severe angina, or whose Hb decreases to critical levels) | Up to Week 49 |
| Number of Participants With Any Adverse Events and Serious Adverse Events | An adverse event (AE) was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. An AE, therefore, could be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the study treatment, whether or not related to the treatment. A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. Number of participants with at least one AE and SAE were reported. | Up to Week 49 |
| Mean Change From Baseline in Vital Signs: Systolic Blood Pressure and Diastolic Blood Pressure up to Week 24 | Change in systolic blood pressure (SBP) and diastolic blood pressure (DBP) at Baseline and end of correction phase (Week 24) is presented. SBP and DBP were determined both before and after the dialysis session for participants. Baseline is defined as Day 1 visit. One participant from CERA group and two participants from Epoetin Beta group did not receive any study medication and were excluded from the safety analysis. | From Baseline (Day 1) to Week 24 |
| Mean Change From Baseline in Vital Sign: Heart Rate Measurements up to Week 24 | Heart rate was measured before blood sampling for all participants and before the dialysis session. Baseline is defined as Day 1. One participant from CERA group and two participants from Epoetin Beta group did not receive any study medication and were excluded from the safety analysis. | From Baseline (Day 1) to Week 24 |
| Number of Participants With Abnormal Changes in Electrocardiogram up to Week 24 | Twelve-lead ECG was recorded before or after the dialysis session. Number of participants with abnormal changes in electrocardiogram observed at any time point was reported. One participant from CERA group and two participants from Epoetin Beta group did not receive any study medication and were excluded from the safety analysis. | Up to Week 24 |
| Seoul |
| 110-744 |
| South Korea |
| Seoul | 134-701 | South Korea |
| Seoul | 135-710 | South Korea |
| Seoul | 137-701 | South Korea |
| Seoul | 405-760 | South Korea |
| Sungnam | 463-802 | South Korea |
| Lack of Efficacy |
|
| Kidney transplantation |
|
| Lost to Follow-up |
|
| RBC transfusion |
|
| NOT COMPLETED |
|
|
Eligible participants were administered Epoetin beta IV three times per week at the starting dose of 40 IU/kg for 24 weeks.
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Correction Phase: Epoetin Beta |
Eligible participants were administered Epoetin beta IV three times per week at the starting dose of 40 IU/kg for 24 weeks. |
|
|
| Secondary | Mean Change From Baseline in Hemoglobin Concentration at Week 24 | Mean hemoglobin levels and their changes in correction phase from baseline were presented. Baseline is defined as Day 1 visit. The mean Hb concentration from Baseline at week 24 was calculated by subtracting the baseline Hb concentration value from the week 24 value | The Intent-to-Treat population included all randomized participants. | Posted | Mean | Standard Deviation | Grams per deciliter (g/dL) | From Baseline (Day 1) to Week 24 |
|
|
|
| Secondary | Median Time in Which Hemoglobin Value Was Maintained Within Target Range of >/= 11g/dL up to Week 24 | Median time during the correction period in which Hb value was maintained within target range of >/= 11.0 g/dL and an increase in hemoglobin from baseline >/= 1.0 g/dL was reported. | The Intent-to-Treat population included all randomized participants. | Posted | Median | 95% Confidence Interval | Days | Up to Week 24 |
|
|
|
| Secondary | Number of Participants Who Received Red Blood Cells Transfusions up to Week 49 | The number of participants who received at least 1 red blood cell transfusion during the study is presented. RBC transfusions was given in case of medical need, i.e., in severely anemic participants with recognized symptoms or signs of anemia (e.g., in participants with acute blood loss, with severe angina, or whose Hb decreases to critical levels) | The Intent-to-Treat Population included all randomized participants. | Posted | Number | Number of participants | Up to Week 49 |
|
|
|
| Secondary | Number of Participants With Any Adverse Events and Serious Adverse Events | An adverse event (AE) was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. An AE, therefore, could be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the study treatment, whether or not related to the treatment. A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. Number of participants with at least one AE and SAE were reported. | All participants who received at least one dose of the study medication and had a safety follow-up, whether withdrawn prematurely or not, included in the Safety Population. One participant from CERA group and two participants from Epoetin Beta group did not receive any study medication and were excluded from the safety analysis. | Posted | Number | Number of participants | Up to Week 49 |
|
|
|
| Secondary | Mean Change From Baseline in Vital Signs: Systolic Blood Pressure and Diastolic Blood Pressure up to Week 24 | Change in systolic blood pressure (SBP) and diastolic blood pressure (DBP) at Baseline and end of correction phase (Week 24) is presented. SBP and DBP were determined both before and after the dialysis session for participants. Baseline is defined as Day 1 visit. One participant from CERA group and two participants from Epoetin Beta group did not receive any study medication and were excluded from the safety analysis. | All participants who received at least one dose of the study medication and had a safety follow-up, whether withdrawn prematurely or not, included in the Safety Population. Only participants available at the time of assessment were included in the analysis. | Posted | Mean | Standard Deviation | millimeters of mercury | From Baseline (Day 1) to Week 24 |
|
|
|
| Secondary | Mean Change From Baseline in Vital Sign: Heart Rate Measurements up to Week 24 | Heart rate was measured before blood sampling for all participants and before the dialysis session. Baseline is defined as Day 1. One participant from CERA group and two participants from Epoetin Beta group did not receive any study medication and were excluded from the safety analysis. | All participants who received at least one dose of the study medication and had a safety follow-up, whether withdrawn prematurely or not, included in the Safety Population. Only participants available at the time of assessment were included in the analysis. | Posted | Mean | Standard Deviation | Beats per minute for heart rate | From Baseline (Day 1) to Week 24 |
|
|
|
| Secondary | Number of Participants With Abnormal Changes in Electrocardiogram up to Week 24 | Twelve-lead ECG was recorded before or after the dialysis session. Number of participants with abnormal changes in electrocardiogram observed at any time point was reported. One participant from CERA group and two participants from Epoetin Beta group did not receive any study medication and were excluded from the safety analysis. | All participants who received at least one dose of the study medication and had a safety follow-up, whether withdrawn prematurely or not, included in the Safety Population. Only participants available at the time of assessment were included in the analysis. | Posted | Number | Number of participants | Up to Week 24 |
|
|
|
| 10 |
| 38 |
| 34 |
| 38 |
| EG001 | Correction Phase: Epoetin Beta | Eligible participants were administered Epoetin beta IV three times per week at the starting dose of 40 IU/kg for 24 weeks. | 6 | 39 | 39 | 39 |
| EG002 | Maintenance Phase: CERA | Eligible participants who achieved a hemoglobin target range of level >=11.0 g/dL at least once during the correction phase (Week 1 to Week 24) without RBC transfusion and completed correction phase treatment, moved to Maintenance phase wherein they were administered CERA (dose adjusted according to the predefined protocol) IV once every 4 weeks for the subsequent 24 weeks. | 8 | 54 | 51 | 54 |
| Glaucoma | Eye disorders | MedDRA (12.0) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
|
| Haematemesis | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
|
| Infection | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
|
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
|
| Femur fracture | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
|
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (12.0) | Systematic Assessment |
|
| Meniscus lesion | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Systematic Assessment |
|
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Systematic Assessment |
|
| Carpal tunnel syndrome | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
|
| Normal pressure hydrocephalus | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
|
| Stupor | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
|
| Pulmonary congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
|
| Aneurysm | Vascular disorders | MedDRA (12.0) | Systematic Assessment |
|
| Haemothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
|
| Arteriosclerosis obliterans | Vascular disorders | MedDRA (12.0) | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
|
| Pneumonia bacterial | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
|
| Reocclusion | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
|
| Vascular graft complication | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
|
| Renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Systematic Assessment |
|
| Cerebral haemorrhage | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | MedDRA (12.0) | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
|
| Epigastric discomfort | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
|
| Gastric ulcer | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA (12.0) | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA (12.0) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
|
| Arteriovenous fistula site complication | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
|
| Foot fracture | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
|
| Haemodialysis - induced symptom | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
|
| Procedural hypotension | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
|
| Vascular graft complication | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
|
| Blood parathyroid hormone increased | Investigations | MedDRA (12.0) | Systematic Assessment |
|
| Blood phosphorus increased | Investigations | MedDRA (12.0) | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (12.0) | Systematic Assessment |
|
| Hyperphosphataemia | Metabolism and nutrition disorders | MedDRA (12.0) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA (12.0) | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA (12.0) | Systematic Assessment |
|
| Renal cyst | Renal and urinary disorders | MedDRA (12.0) | Systematic Assessment |
|
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA (12.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Systematic Assessment |
|
| Tooth extraction | Surgical and medical procedures | MedDRA (12.0) | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (12.0) | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA (12.0) | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | 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.
| 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 |
|
| Post-dialysis: SBP |
|
| Post-dialysis: DBP |
|