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A randomized, controlled, open-label, multicenter, parallel-group study to demonstrate the efficacy and safety of RO0503821 when administered intravenously for the maintenance treatment of anemia in patients with chronic kidney disease who are on dialysis Clinical Trials Information presented on Clinical Trials Search is not intended to be a substitute for qualified health advice, trips or treatment by using a genuine doctor. We aren't doctors. Always consult your mD on A randomized, controlled, open-label, multicenter, parallel-group study to demonstrate the efficacy and safety of RO0503821 when administered intravenously for the maintenance treatment of anemia in patients with chronic kidney disease who are on dialysis conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. A randomized, controlled, open-label, multicenter, parallel-group study to demonstrate the efficacy and safety of RO0503821 when administered intravenously for the maintenance treatment of anemia in patients with chronic kidney disease who are on dialysis Clinical research trials and A randomized, controlled, open-label, multicenter, parallel-group study to demonstrate the efficacy and safety of RO0503821 when administered intravenously for the maintenance treatment of anemia in patients with chronic kidney disease who are on dialysis health trials take place in a lot of of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / projects is to answer specific human medical questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, like A randomized, controlled, open-label, multicenter, parallel-group study to demonstrate the efficacy and safety of RO0503821 when administered intravenously for the maintenance treatment of anemia in patients with chronic kidney disease who are on dialysis. A randomized, controlled, open-label, multicenter, parallel-group study to demonstrate the efficacy and safety of RO0503821 when administered intravenously for the maintenance treatment of anemia in patients with chronic kidney disease who are on dialysis Clinical Trials and other clinical trials allow for volunteers to have health treatment alternatives before they are available to the general public. Many times the test subjects obtain treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a A randomized, controlled, open-label, multicenter, parallel-group study to demonstrate the efficacy and safety of RO0503821 when administered intravenously for the maintenance treatment of anemia in patients with chronic kidney disease who are on dialysis clinical trial. Subjects oftentimes recieve the most effective healthcare possible for their A randomized, controlled, open-label, multicenter, parallel-group study to demonstrate the efficacy and safety of RO0503821 when administered intravenously for the maintenance treatment of anemia in patients with chronic kidney disease who are on dialysis condition. Hazards are a reality, however, and could include additional or frequent doctor visits, healthcare dangers (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > A randomized, controlled, open-label, multicenter, parallel-group study to demonstrate the efficacy and safety of RO0503821 when administered intravenously for the maintenance treatment of anemia in patients with chronic kidney disease who are on dialysis  A randomized, controlled, open-label, multicenter, parallel-group study to demonstrate the efficacy and safety of RO0503821 when administered intravenously for the maintenance treatment of anemia in patients with chronic kidney disease who are on dialysis
A randomized, controlled, open-label, multicenter, parallel-group study to demonstrate the efficacy and safety of RO0503821 when administered intravenously for the maintenance treatment of anemia in patients with chronic kidney disease who are on dialysis
For Condition: Renal Anemia
Status: Recruiting
Sponsor(s): Hoffmann-La Roche ,
Synopsis: The primary purpose of this study is to demonstrate that RO0503821 administered intravenously maintains hemoglobin concentrations in dialysis patients on prior intravenous epoetin maintenance treatment of chronic renal anemia. The secondary purpose is to assess the safety and tolerability of intravenous administration of RO0503821 in this patient patient population.
Details:
Eligibility:
Study Type: Interventional, Treatment
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 - Urea clearance/volume (Kt/V) greater than or equal to 1.2 or percent recution of urea (URR) greater than or equal to 65% for hemodialysis patients or weekly urea clearance/volume (Kt/V) greater than or equal to 1.8 for peritoneal dialysis patients - 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 (defined as an absolute difference less than or equal to 1 g/dL between the mean hemoglobin values determined in weeks -4 and -3 and the mean hemoglobin values determined in weeks -2 and -1) - Continuous intravenous maintenance epoetin therapy (epoetin alfa formulated with human albumin or epoetin beta) with the same dosing interval (i.e., one, two or three times weekly) for at least 8 weeks before screening and during the screening/baseline period - Stable intravenous maintenance epoetin therapy (epoetin alfa formulated with human albumin or epoetin beta) during the screening/baseline period (a maximum of one weekly dose change is allowed: this change should not exceed 25% compared to the weekly dose administered in the week preceding screening) - Adequate iron status defined as serum ferritin greater than or equal to 100 ng/mL or transferrin saturation (TSAT) greater than or equal to 20% (or percentage of hypochromic RBCs less than 10%) (mean of two values determined in weeks -4 and -3) 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 - CRP (C Reactive Protein) greater than 30 mg/L - 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: BA16739;
Study Start Date:
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00077610
Other Renal Anemia Studies:
1. A randomized, controlled, open-label, multi-center, parallel-group study to demonstrate the efficacy and safety of RO0503821 when administered subcutaneously for the maintenance treatment of anemia in patients w/ chronic kidney disease who are on dialysis
2. A study of switching from maintenance treatment with intravenous epoetin alfa to maintenance treatment with intravenous Ro 50-3821 in hemodialysis patients with chronic renal anemia
3. A randomized, controlled, open-label, multicenter, parallel-group study to demonstrate the efficacy and safety of RO0503821 when administered intravenously for the maintenance treatment of anemia in patients with chronic kidney disease who are on dialysis
4. A randomized, controlled, open-label, multi-center, parallel-group study to demonstrate the efficacy and safety of RO0503821 when administered intravenously for the maintenance treatment of anemia in patients w/ chronic kidney disease who are on dialysis
5. An open-label, randomized, multi-center, parallel group study to demonstrate correction of anemia using intravenous injections of RO0503821 in patients with chronic kidney disease who are on dialysis
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A randomized, controlled, open-label, multicenter, parallel-group study to demonstrate the efficacy and safety of RO0503821 when administered intravenously for the maintenance treatment of anemia in patients with chronic kidney disease who are on dialysis
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