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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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14 November 2016 |
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Main ID: |
NCT01667380 |
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Date of registration:
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13/08/2012 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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An Observational Study of Mircera in Patients With Chronic Renal Anemia on Dialysis (CKD Stage V) or Not on Dialysis (CKD Stage III-IV)
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Scientific title:
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Non-interventional Study on the Use of Mircera in the Treatment of Chronic Renal Anemia in Patients With Chronic Kidney Disease Stages III-IV Not on Dialysis and in Patients on Stage V on Hemodialysis |
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Date of first enrolment:
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April 2012 |
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Target sample size:
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78 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01667380 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort, Time Perspective: Prospective
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Phase:
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N/A
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Countries of recruitment
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Montenegro
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Contacts
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Name:
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Clinical Trials |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hoffmann-La Roche |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Adult patients, >/= 18 years of age
- Patients with chronic renal anemia with stage III-IV CKD not on dialysis and who are,
in the opinion of the treating physician, not expected at baseline to require
dialysis within 12 months
- Patients with chronic renal anemia with stage V CKD on dialysis
- No contraindication to ESA treatment
Exclusion Criteria:
- Uncontrolled hypertension
- Hypersensitivity to the active substance or any other of the excipients of Mircera
and other ESAs
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Anemia
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Primary Outcome(s)
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Dosage/schedule of Mircera treatment in clinical practice
[Time Frame: approximately 3 years]
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Secondary Outcome(s)
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Change in Hb levels
[Time Frame: from baseline to Month 12]
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Proportion of patients with mean Hb level 10-12 g/dL 10 to 12 months after initiation of treatment
[Time Frame: approximately 3 years]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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