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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 Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about 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 conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. 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 Clinical research trials and 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 medical trials happen in hundreds of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as 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. 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 Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a 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 clinical trial. Participants frequently get the best healthcare available for their 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 condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), 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 > 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  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
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
For Condition: Renal Anemia
Status: Recruiting
Sponsor(s): Hoffmann-La Roche ,
Synopsis: The primary purpose of this study is to demonstrate the efficacy of RO0503821 administered intravenously for the treatment of anemia in patients with chronic kidney disease who are on dialysis. The secondary purpose is to assess the safety and tolerability of multiple doses of RO0503821 during the correction and the extension periods 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 (CKD stage 5) - Maintenance hemodialysis or peritoneal dialysis, for at least two weeks before screening and during the screening period - Measured 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 predialysis (for HD patients) Hb concentration 8 - 11 g/dL determined from the mean of 2 screening values with at least one day between measurements - 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 red cells less than 10%); mean of two values measured during screening with at least one day between measurements - All patients must receive iv iron supplementation during the screening period Exclusion Criteria: - Previous therapy with recombinant human erythropoietin or any other erythropoietic substance within 12 weeks prior to screening. If epoetin treatment has been interrupted for at least 12 weeks, the patient may be enrolled in the study. Ongoing epoetin treatment should not be discontinued to allow participation in the trial. - Failing renal graft in place - Overt gastrointestinal bleeding or any other bleeding episode necessitating transfusion within 8 weeks before screening or during the screening period - RBC transfusions within 8 weeks before screening or during the screening 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 (sitting systolic blood pressure greater than or equal to 170 mm Hg or diastolic blood pressure greater than or equal to 100 mm Hg – average of two predialysis values) - Epileptic seizures 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 disease, stroke, severe liver disease within the 12 weeks before screening or during the screening period) - Planned elective surgery during the entire study period (except dialysis access surgery) - Life expectancy less than 12 months - Pregnancy or breast-feeding - Women of childbearing potential without effective contraceptive methods - 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: BA16736;
Study Start Date:
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00077597
Other Renal Anemia Studies:
1. 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
2. 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
3. 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
4. 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
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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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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