Back to resultsA Study of Epoetin Beta (NeoRecormon) in Predialysis Patients With Renal Anemia
Primary Purpose
Anemia
Status
Completed
Phase
Phase 4
Locations
Bulgaria
Study Type
Interventional
Intervention
Epoetin Beta
Sponsored by
About this trial
This is an interventional treatment trial for Anemia
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Epoetin Beta
Arm Description
Patients will be administered 3 times (X) 30 International unis per kilogram(IU/Kg body weight per week of eopetin beta subcurtaneously using the device RecoPen. The dosage could be increased every 4 weeks by 3 X20 IU/Kg.
Outcomes
Primary Outcome Measures
Percentage of participantss who change to once weekly NeoRocormon
Percentage of participants with local intolerabilities (pain/allergic reactions)
Percentage of participants who withdrew due to inability to use RecoPen
Percentage of participants who changed dose during treatmnent
Secondary Outcome Measures
Quality of life evaluated by the Short Form 36
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02569515
Brief Title
A Study of Epoetin Beta (NeoRecormon) in Predialysis Patients With Renal Anemia
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
October 2004 (undefined)
Primary Completion Date
July 2006 (Actual)
Study Completion Date
July 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
Brief Summary
This study will evaluate the tolerability, and effect on quality of life, in patients receiving multi-dose NeoRecormon administered by RecoPen in predialysis patients with chronic renal anemia. The anticipated time on study treatment is 10 months, and the target sample size is 60 individuals.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
58 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Epoetin Beta
Arm Type
Experimental
Arm Description
Patients will be administered 3 times (X) 30 International unis per kilogram(IU/Kg body weight per week of eopetin beta subcurtaneously using the device RecoPen. The dosage could be increased every 4 weeks by 3 X20 IU/Kg.
Intervention Type
Drug
Intervention Name(s)
Epoetin Beta
Other Intervention Name(s)
NeoRecormon
Intervention Description
Initial dose: 3X30 IU/Kg body weight administered subcutaneously using RecoPen. Dosage could be increased by 3X20 IU/Kg every 4 weeks up to a maximum of 720 IU/Kg per week.
Primary Outcome Measure Information:
Title
Percentage of participantss who change to once weekly NeoRocormon
Time Frame
10 months
Title
Percentage of participants with local intolerabilities (pain/allergic reactions)
Time Frame
10 months
Title
Percentage of participants who withdrew due to inability to use RecoPen
Time Frame
10 months
Title
Percentage of participants who changed dose during treatmnent
Time Frame
10 months
Secondary Outcome Measure Information:
Title
Quality of life evaluated by the Short Form 36
Time Frame
10 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Chair
Facility Information:
City
Sofia
ZIP/Postal Code
1233
Country
Bulgaria
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
City
Sofia
ZIP/Postal Code
1504
Country
Bulgaria
City
Varna
ZIP/Postal Code
9002
Country
Bulgaria
12. IPD Sharing Statement
Learn more about this trial
A Study of Epoetin Beta (NeoRecormon) in Predialysis Patients With Renal Anemia
We'll reach out to this number within 24 hrs