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RO0503821 for the Maintenance Treatment of Anemia in Patients with Chronic Kidney Disease who Are on Dialysis Clinical Trials Resources presented on Clinical Trials Search is not meant to be a substitute for proven health advice, calls or treatment with a real medical. We aren't mDs. Always consult your doctor on RO0503821 for the Maintenance Treatment of Anemia in Patients with Chronic Kidney Disease who Are on Dialysis conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. RO0503821 for the Maintenance Treatment of Anemia in Patients with Chronic Kidney Disease who Are on Dialysis Clinical research trials and RO0503821 for the Maintenance Treatment of Anemia in Patients with Chronic Kidney Disease who Are on Dialysis healthcare trials take place in a lot of of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectiveness of new does drugs. The function of the studies / projects is to figure out specific human medical questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to find cures for all varieties of conditions, like RO0503821 for the Maintenance Treatment of Anemia in Patients with Chronic Kidney Disease who Are on Dialysis. RO0503821 for the Maintenance Treatment of Anemia in Patients with Chronic Kidney Disease who Are on Dialysis Clinical Trials and other clinical trials allow volunteers to access health treatment options before they are available to the masses. Many times the subjects receive professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a RO0503821 for the Maintenance Treatment of Anemia in Patients with Chronic Kidney Disease who Are on Dialysis clinical trial. Human subjects often obtain the finest healthcare possible for their RO0503821 for the Maintenance Treatment of Anemia in Patients with Chronic Kidney Disease who Are on Dialysis condition. Hazards are a reality, nevertheless, and might include additional or frequent dr. calls, health hazards (potentially life-jeopardizing), and/or the treatment being uneffective. Trials are federally regulated with stern guidelines to protect clinical trials patients.
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Home > "R" Clinical Trials Conditions > RO0503821 for the Maintenance Treatment of Anemia in Patients with Chronic Kidney Disease who Are on Dialysis  RO0503821 for the Maintenance Treatment of Anemia in Patients with Chronic Kidney Disease who Are on Dialysis
RO0503821 for the Maintenance Treatment of Anemia in Patients with Chronic Kidney Disease who Are on Dialysis
For Condition: Anemia
Status: Not yet recruiting
Sponsor(s): Hoffmann-La Roche ,
Synopsis: The primary purpose of this study is to demonstrate that RO0503821 administered with pre-filled syringes maintains hemoglobin concentrations in dialysis patients on prior intravenous or subcutaneous epoetin maintenance treatment of chronic renal anemia.
Details:
Eligibility:
Study Type: Interventional, Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - Written informed consent - Adult patients (greater than or equal to 18 years old) with chronic renal anemia - Regular long-term hemodialysis or peritoneal dialysis therapy with the same mode of dialysis for at least 12 weeks before screening and during the screening/baseline period - Baseline hemoglobin concentration between 10.5 and 13 g/dL (mean of the weekly hemoglobin values determined in weeks -4 to -1) - Stable baseline hemoglobin concentration - Continuous maintenance epoetin therapy with the same dosing interval (i.e., one, two or three times weekly) and route (intravenous or subcutaneous) for at least 8 weeks before screening (a maximum of one missed dose is allowed) - Continuous maintenance epoetin therapy with the same dosing interval (i.e., one, two or three times weekly) and route (intravenous or subcutaneous) during the screening/baseline period (no missed dose is allowed) - Stable maintenance epoetin therapy during the screening/baseline period (a maximum of one change of the weekly dose is allowed: this change should not exceed 25% compared to the weekly dose administered in the week preceding screening) - Adequate iron status Exclusion Criteria: - Overt gastrointestinal bleeding or any other bleeding episode necessitating transfusion within 8 weeks before screening or during the screening/baseline period - RBC transfusions within 8 weeks before screening or during the screening/baseline period - Hemoglobinopathies (e.g., homozygous sickle-cell disease, thalassemia of all types) - Hemolysis - Active malignant disease (except non-melanoma skin cancer) - Chronic, uncontrolled or symptomatic inflammatory disease (e.g., rheumatoid arthritis, systemic lupus erythematosus) - Acute infection - Temporary (untunneled) dialysis access catheter - Vitamin B12 deficiency - Folic acid deficiency - Uncontrolled or symptomatic secondary hyperparathyroidism - Poorly controlled hypertension necessitating interruption of epoetin treatment in the 6 months before screening - Epileptic seizure in the 6 months before screening - Platelets greater than 500 x 10 9/L - Pure red cell aplasia - Chronic congestive heart failure (New York Heart Association Class IV) - High likelihood of early withdrawal or interruption of the study (e.g. myocardial infarction, severe or unstable coronary artery disease, stroke, severe liver disease within the 12 weeks before screening or during the screening/baseline period) - Planned elective surgery during the study period - Life expectancy less than 12 months - Pregnancy or breast-feeding - Women of childbearing potential without effective contraception - Previous treatment with RO0503821 - Administration of another investigational drug within 4 weeks before screening or planned during the study period - Known hypersensitivity to recombinant human erythropoietin, polyethylene glycol or to any constituent of the study or reference drug formulations
Total Enrollment:
Location and Contact Information:
Additional Information:
Study ID Numbers: BA17284;
Study Start Date:
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00081484
Other Anemia Studies:
1. Darbepoetin alfa in Treating Anemia in Patients With Cancer Who Are Receiving Chemotherapy
2. Radiation Therapy and Cisplatin With or Without Epoetin Alfa in Treating Patients With Cervical Cancer and Anemia
3. Anemia and Surgery: Indications For Transfusion
4. Exercise Plus Epoetin Alfa in Treating Cancer Patients Who Have Anemia-Related Fatigue
5. Epoetin Alfa in Treating Chemotherapy-Related Anemia in Women With Stage I, Stage II, or Stage III Breast Cancer
Related Studies:
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RO0503821 for the Maintenance Treatment of Anemia in Patients with Chronic Kidney Disease who Are on Dialysis
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