A Study of Intravenous (iv) Mircera in Hemodialysis Patients With Chronic Renal Anemia

Anemia Clinical Trial

Official title:

A Randomized, Open-label Study of Dose Conversion Factors for Maintenance Intravenous Mircera in Hemodialysis Patients With Chronic Renal Anemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00048035
• Other study ID #: BA16285
• Status: Completed
• Phase: Phase 2
• First received: October 24, 2002
• Last updated: October 1, 2015
• Start date: February 2002
• Est. completion date: December 2005

Study information

• Verified date: October 2015
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study will determine the appropriate dose and frequency of administration of iv Mircera maintenance therapy in hemodialysis patients with chronic renal anemia who were previously receiving iv epoetin. The anticipated time on study treatment is 3-12 months and the target sample size is <100 individuals.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: December 2005
• Est. primary completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• adult patients >=18 years of age;

• chronic renal anemia;

• on hemodialysis therapy for at least 3 months;

• receiving iv epoetin alfa during the 2 weeks prior to the run-in period.

Exclusion Criteria:

• women who are pregnant, breastfeeding or using unreliable birth control methods;

• use of any investigational drug within 30 days of the run-in phase, or during the run-in or study treatment period.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia

Intervention

Drug:
• methoxy polyethylene glycol-epoetin beta [Mircera]
Differing doses and frequencies of iv administration

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in hemoglobin from baseline over time under constant dosing regimen\n		Throughout study	No
Secondary	Change in hematocrit from baseline over time under constant dosing regimen. Vital signs, adverse events, laboratory values\n		Throughout study	No