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

Anemia Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02569515
• Other study ID #: ML18101
• Status: Completed
• Phase: Phase 4
• First received: October 5, 2015
• Last updated: November 1, 2016
• Start date: October 2004
• Est. completion date: July 2006

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Bulgaria: Bulgarian Drug Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: July 2006
• Est. primary completion date: July 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Bulgaria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of participantss who change to once weekly NeoRocormon		10 months	No
Primary	Percentage of participants with local intolerabilities (pain/allergic reactions)		10 months	No
Primary	Percentage of participants who withdrew due to inability to use RecoPen		10 months	No
Primary	Percentage of participants who changed dose during treatmnent		10 months	No
Secondary	Quality of life evaluated by the Short Form 36		10 months	No