- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01892202
A Non-Interventional Study of Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) in Patients With Chronic Kidney Disease Not on Dialysis
October 26, 2016 updated by: Hoffmann-La Roche
Efficacy of C.E.R.A for Correction of Anemia and Maintenance of the Hb Levels in CKD Patients in Stage III - IV , Not on Dialysis , Treated According to Routine Clinical Practice
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 clinical practice.
Eligible patients treated with Mircera for chronic renal anemia according to the standard of care and in line with the current local label will be followed for 6 months.
Study Overview
Study Type
Expanded Access
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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 Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2011
Primary Completion (Anticipated)
February 1, 2011
Study Completion (Anticipated)
February 1, 2011
Study Registration Dates
First Submitted
June 27, 2013
First Submitted That Met QC Criteria
July 1, 2013
First Posted (Estimate)
July 4, 2013
Study Record Updates
Last Update Posted (Estimate)
October 27, 2016
Last Update Submitted That Met QC Criteria
October 26, 2016
Last Verified
October 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ML25750
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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