A Randomized, Open-label Study of the Effect of Intravenous Mircera on Hemoglobin Level/Correction in Dialysis Patients With Chronic Kidney Disease
epoetin
+ methoxy polyethylene glycol-epoetin beta [Mircera]
Anemia
+ Hematologic Diseases
Treatment Study
Summary
Study start date: February 1, 2004
Actual date on which the first participant was enrolled.This study will assess the efficacy and safety of Mircera given intravenously in the treatment of renal anemia in chronic kidney disease patients on dialysis who are not currently receiving epoetin or any other erythropoietic substance. The anticipated time on study treatment is 1-2 years and the target sample size is 100-500 individuals.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.182 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: * adult patients \>=18 years of age; * chronic renal anemia; * dialysis therapy for at least 2 weeks before screening. Exclusion Criteria: * women who are pregnant, breastfeeding or using unreliable birth control methods; * administration of any investigational drug within 4 weeks before screening.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Active ComparatorGroup II
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives