A Study of Once-Monthly Intravenous Mircera in Hemodialysis Patients With Chronic Renal Anemia.

Anemia Clinical Trial

Official title:

An Open Label Study to Assess the Maintenance of Hemoglobin Levels, Safety and Tolerability of Once Monthly Administration of Mircera in Hemodialysis Patients With Chronic Renal Anemia.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00560547
• Other study ID #: ML21349
• Status: Withdrawn
• Phase: Phase 3
• First received: November 16, 2007
• Last updated: August 23, 2016
• Start date: October 2007
• Est. completion date: October 2009

Study information

• Verified date: August 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Laegemiddelstyrelsen (DMA)
• Study type: Interventional

Clinical Trial Summary

This single arm study will assess the long-term maintenance of hemoglobin levels, safety and tolerability of once-monthly intravenous administration of Mircera in hemodialysis patients with chronic renal anemia. Patients currently receiving darboepoetin alfa or epoetin alfa maintenance treatment will receive intravenous Mircera at a starting dose of 120, 200 or 360 micrograms/4 weeks (based on the ESA dose administered on week-1). Subsequent doses will be adjusted to maintain hemoglobin levels within the target range of 10.5-12.5g/dL. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• adult patients, >=18 years of age;

• chronic renal anemia;

• regular long-term hemodialysis therapy with the same mode of dialysis for >=3 months;

• continuous iv or sc maintenance ESA treatment during previous 2 months.

Exclusion Criteria:

• transfusion of red blood cells during previous 2 months;

• significant acute or chronic bleeding, such as overt gastrointestinal bleeding;

• active malignant disease (except non-melanoma skin cancer).

Study Design

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

Related Conditions & MeSH terms

• Anemia

Intervention

Drug:
• methoxy polyethylene glycol-epoetin beta
120, 200 or 360 micrograms / 4 weeks iv (starting dose)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients maintaining average Hb concentration within target range during evaluation period		Weeks 17-24	No
Secondary	Change in Hb concentration between reference and evaluation period; mean time spent in, and percentage of patients maintaining Hb within target range		Weeks 17-24	No
Secondary	Dose adjustments; RBC transfusions		Throughout study	No
Secondary	AEs, laboratory parameters, vital signs		Throughout study	No