Status:
COMPLETED
A Study to Assess All-Cause Mortality and Cardiovascular Morbidity in Participants With Chronic Kidney Disease (CKD) on Dialysis and Those Not on Renal Replacement Therapy Receiving Methoxy Polyethylene Glycol-Epoetin Beta (Mircera) or Reference Erythropoietin Stimulating Agents (ESAs)
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Chronic Renal Anemia
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This 2 arm safety study will compare the outcome with respect to a composite endpoint of all-cause mortality and non-fatal cardiovascular events (myocardial infarction, stroke) in CKD participants eit...
Eligibility Criteria
Inclusion
- Male or female participants with symptomatic anemia associated with CKD
- Participants with renal anemia who are not treated with an ESA:
- Anemia was defined as hemoglobin (Hb) concentration less than (\<) 11.0 grams per deciliter (g/dL) (mean of 2 screening values with at least one day and a maximum of 2 weeks between measurements) with clinical indication for ESA treatment
- Participants with renal anemia who are on maintenance ESA therapy:
- If on dialysis: regular long-term hemodialysis or peritoneal dialysis therapy with the same mode of dialysis for at least 3 months before screening
- Hb concentration between 10 and 12 g/dL (mean of 2 screening values with at least one day and a maximum of 2 weeks between measurements)
- Participants with adequate iron status defined as: serum ferritin above or equal to 100 micrograms per liter or transferrin saturation above or equal to 20 percent
Exclusion
- Contraindications to ESA treatment: uncontrolled hypertension, hypersensitivity to the active substance or any of the excipients, any other contraindication to ESA therapy
- Conditions known to cause inadequate response to ESA treatment or anemia other than symptomatic anemia associated with CKD:
- History of hemoglobinopathy
- Anemia due to hemolysis
- Pure red cell aplasia
- High likelihood of early withdrawal (for example, within 1 year) or interruption of the study
- Pregnancy or breast-feeding
- Women of childbearing potential without effective contraception
- Administration of another investigational drug within 1 month before screening or planned during the study period
Key Trial Info
Start Date :
December 12 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 27 2017
Estimated Enrollment :
2825 Patients enrolled
Trial Details
Trial ID
NCT00773513
Start Date
December 12 2008
End Date
July 27 2017
Last Update
August 20 2019
Active Locations (196)
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1
Fresenius Medical Care Martinez
Buenos Aires, Argentina, 1640
2
Fresenius Medical Care Morón
Buenos Aires, Argentina, 1708
3
Fresenius Medical Care San Martin
Buenos Aires, Argentina, B1650IHM
4
Fresenuis Medical Care Mansilla
CABA, Argentina, 1425