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A Study of Epoetin Beta (NeoRecormon) in Predialysis Patients With Renal Anemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02569515
Recruitment Status : Completed
First Posted : October 6, 2015
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

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.

Condition or disease Intervention/treatment Phase
Anemia Drug: Epoetin Beta Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : October 2004
Actual Primary Completion Date : July 2006
Actual Study Completion Date : July 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia

Arm Intervention/treatment
Experimental: Epoetin Beta
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.
Drug: Epoetin Beta
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.
Other Name: NeoRecormon




Primary Outcome Measures :
  1. Percentage of participantss who change to once weekly NeoRocormon [ Time Frame: 10 months ]
  2. Percentage of participants with local intolerabilities (pain/allergic reactions) [ Time Frame: 10 months ]
  3. Percentage of participants who withdrew due to inability to use RecoPen [ Time Frame: 10 months ]
  4. Percentage of participants who changed dose during treatmnent [ Time Frame: 10 months ]

Secondary Outcome Measures :
  1. Quality of life evaluated by the Short Form 36 [ Time Frame: 10 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02569515


Locations
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Bulgaria
Sofia, Bulgaria, 1233
Sofia, Bulgaria, 1431
Sofia, Bulgaria, 1504
Varna, Bulgaria, 9002
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Chair: Clinical Trials Hoffmann-La Roche
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02569515    
Other Study ID Numbers: ML18101
First Posted: October 6, 2015    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016
Additional relevant MeSH terms:
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Anemia
Hematologic Diseases
Epoetin Alfa
Hematinics