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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: |
NCT02569515 |
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Date of registration:
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05/10/2015 |
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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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A Study of Epoetin Beta (NeoRecormon) in Predialysis Patients With Renal Anemia
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Scientific title:
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An Open-Label Study of the Tolerability and Flexibility of Multi-Dose NeoRecormon Administered by Reco-Pen in Pre-Dialysis Patients With Chronic Renal Anemia. |
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Date of first enrolment:
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October 2004 |
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Target sample size:
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58 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02569515 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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Bulgaria
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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 18-65 years of age
- Chronic renal failure (Stages I-III)
- No previous epoetin therapy
Exclusion Criteria:
- Poorly controlled hypertension
- History or evidence of malignancy
- Relevant acute or chronic bleeding (requiring therapy) within 3 months before study
drug
- Women who are pregnant or breastfeeding
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Anemia
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Intervention(s)
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Drug: Epoetin Beta
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Primary Outcome(s)
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Percentage of participants who withdrew due to inability to use RecoPen
[Time Frame: 10 months]
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Percentage of participants with local intolerabilities (pain/allergic reactions)
[Time Frame: 10 months]
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Percentage of participantss who change to once weekly NeoRocormon
[Time Frame: 10 months]
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Percentage of participants who changed dose during treatmnent
[Time Frame: 10 months]
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Secondary Outcome(s)
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Quality of life evaluated by the Short Form 36
[Time Frame: 10 months]
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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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