Status:
NO_LONGER_AVAILABLE
A Non-Interventional Study of Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) in Patients With Chronic Kidney Disease Not on Dialysis
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Anemia
Eligibility:
All Genders
18-65 years
Brief Summary
This multicenter observational study will evaluate the efficacy and safety of Mircera (methoxy polyethylene glycol-epoetin beta) in patients with chronic kidney disease not on dialysis in routine clin...
Eligibility Criteria
Inclusion
- Adult patients, 18 to 65 years of age inclusive
- Patients with chronic kidney disease Stage III-IV not on dialysis
- Hb \< 10 g/dL (for correction of anemia) or Hb 10-12 g/dL and receiving any other ESA (for maintenance of Hb levels)
- Adequate iron status as judged by the treating physician
Exclusion
- Hypersensitivity to recombinant human erythropoietin, polyethylene glycol or to any constituent of the study medication
- Significant acute or chronic bleeding
- Hemoglobinopathies (e.g. homozygous sickle-cell disease, thalassemia of all types)
- Active malignant disease during the last five years (except non-melanoma skin cancer)
- Uncontrolled or symptomatic secondary hyperparathyroidism
- Epileptic seizure during the last 6 months
- Poorly controlled hypertension (sitting blood pressure \> 170/100 mmHG)
- Myocardial infarction or stroke, or severe or unstable CAD
- Severe liver disease during the previous 6 months
- Congestive heart failure NYHA Class III-IV
- Diagnosis or suspicion of pure red cell aplasia (PRCA)
- Planned elective surgery during the study period (except cataract surgery and vascular access surgery)
- Transfusion of red blood cells during the previous 2 months
- Pregnant women
- Any contra-indications to Mircera
Key Trial Info
Start Date :
February 1 2011
Trial Type :
EXPANDED_ACCESS
End Date :
February 1 2011
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01892202
Start Date
February 1 2011
End Date
February 1 2011
Last Update
October 27 2016
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