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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 Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified medical advice, visits or professional assistance with a genuine dr.. We are not doctors. Always consult your mD about 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 conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. 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 Clinical research trials and 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 medical trials take place in many of places throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectiveness of new does drugs. The purpose of the studies / projects is to solve specific human healthcare questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to find cures for all varieties of conditions, like 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. 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 Clinical Trials and other clinical trials allow for volunteers to have health treatment options before they are available to the masses. Many times the human subjects acquire professional assistance for free of charge, and sometimes they are compensated for their time. Occasionally there is a cost for a 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 clinical trial. Test subjects typically obtain the finest healthcare available for their 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 condition. Dangers are a reality, nevertheless, and might include additional or frequent doctor trips, medical dangers (possibly life-jeopardising), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > 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  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
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
For Condition: Renal Anemia
Status: Recruiting
Sponsor(s): Hoffmann-La Roche ,
Synopsis: The primary purpose of this study is to demonstrate that RO0503821 administered subcutaneously maintains hemoglobin concentrations in dialysis patients on prior subcutaneous epoetin maintenance treatment of chronic renal anemia. The secondary purpose is to assess the safety and tolerability of subcutaneous administration of RO0503821 in this 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 reduction 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 subcutaneous 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 subcutaneous maintenance epoetin therapy (epoetin alfa formulated with human albumin or epoetin beta) during the screening/baseline period (no change of the weekly dose) - 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: BA16740;
Study Start Date:
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00077623
Other Renal Anemia Studies:
1. 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
2. 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
3. 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
4. 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
5. 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
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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
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