Anemia Clinical Trial
Official title:
An Open-label, Multi-center Study to Document the Efficacy, Safety, and Tolerability of Long-term Administration of RO0503821 in Patients With Chronic Renal Anemia
Verified date | February 2012 |
Source | Hoffmann-La Roche |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
This study assessed the long-term efficacy, safety, and tolerability of intravenous (iv) or subcutaneous (sc) methoxy polyethylene glycol-epoetin beta in chronic kidney disease patients with renal anemia. Eligible patients were those who were receiving stable maintenance therapy with methoxy polyethylene glycol-epoetin beta or erythropoiesis stimulating agents (ESAs) in Phase II or III clinical studies. They continued to receive methoxy polyethylene glycol-epoetin beta or comparator ESAs at the same weekly dose and by the same route of administration (sc or iv) as in the qualifying studies.
Status | Completed |
Enrollment | 1228 |
Est. completion date | December 2009 |
Est. primary completion date | December 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Written informed consent - Adult patients (= 18 years old) with chronic renal anemia - Maintenance erythropoietic therapy with methoxy polyethylene glycol-epoetin beta or a protocol-specified reference medication (epoetin alfa formulated with human albumin, epoetin beta or darbepoetin alfa) in one of the following studies: BA16528[NCT00048048], BA16285[NCT00048035], BA16286[NCT00364832], BA16736[NCT00077597], BA16738[NCT00081471], BA16739[NCT00077610], BA16740[NCT00077623], BA17283[NCT00077766] and BA17284[NCT00081484] - Hemoglobin (Hb) concentration between 10.5 and 13.0 g/dL - Adequate iron status defined as serum ferritin = 100 ng/mL or Transferrin Saturation (TSAT)= 20% or percentage of hypochromic red blood cells (RBCs) < 10% Exclusion Criteria: - Poorly controlled hypertension - History of epileptic seizure - Pure red cell aplasia - Chronic congestive heart failure [New York Heart Association (NYHA) IV] - High likelihood of early withdrawal or interruption of the study - Active malignant disease (except non-melanoma skin cancer) - Life expectancy less than 12 months - Pregnancy or breast-feeding |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Hoffmann-La Roche |
United States, Australia, Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Italy, Mexico, Netherlands, Norway, Panama, Poland, Portugal, Puerto Rico, Russian Federation, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change From Baseline in Hemoglobin Concentration to the Last Month of Study Participation | Blood samples were collected at each study visit, that is, every 4 weeks for the first 12 weeks, every 12 weeks until week 105 of the first study period, every 3 months thereafter, and at the end of study or the last visit if the patient discontinued the study prematurely. | Baseline to the end of the study (Up to 49 Months) | No |
Secondary | Percentage of Patients Who Had at Least 1 Adverse Event | See the adverse events section of the results for more information. | From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) | Yes |
Status | Clinical Trial | Phase | |
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