NCT00560547

Brief 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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2007

Geographic Reach
1 country

3 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 16, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 19, 2007

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

August 24, 2016

Status Verified

August 1, 2016

First QC Date

November 16, 2007

Last Update Submit

August 23, 2016

Conditions

Anemia

Outcome Measures

Primary Outcomes (1)

  • Percentage of patients maintaining average Hb concentration within target range during evaluation period

    Weeks 17-24

Secondary Outcomes (3)

  • 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

  • Dose adjustments; RBC transfusions

    Throughout study

  • AEs, laboratory parameters, vital signs

    Throughout study

Study Arms (1)

1

EXPERIMENTAL
Drug: methoxy polyethylene glycol-epoetin beta

Interventions

methoxy polyethylene glycol-epoetin betaDRUG

120, 200 or 360 micrograms / 4 weeks iv (starting dose)

Also known as: Mircera
1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Unknown Facility

Aalborg, 9100, Denmark

Location

Unknown Facility

Fredericia, 7000, Denmark

Location

Unknown Facility

Roskilde, 4000, Denmark

Location

MeSH Terms

Conditions

Anemia

Interventions

continuous erythropoietin receptor activator

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 16, 2007

First Posted

November 19, 2007

Study Start

October 1, 2007

Study Completion

October 1, 2009

Last Updated

August 24, 2016

Record last verified: 2016-08

Locations

DK(3)