NCT01213485

Brief Summary

This observational study will evaluate the course of treatment, the efficacy on anemia and the safety of Mircera (methoxy polyethylene glycol-epoetin beta) in patients with chronic kidney disease on dialysis. Eligible patients will be on either haemodialysis or peritoneal dialysis and treatment-naïve for or having had prior therapy with erythropoiesis stimulating agents (ESA). Data will be collected from each patient for 12 months.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
419

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2010

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 28, 2010

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 4, 2010

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

November 2, 2016

Status Verified

November 1, 2016

Enrollment Period

1.6 years

First QC Date

September 28, 2010

Last Update Submit

November 1, 2016

Conditions

Anemia

Outcome Measures

Primary Outcomes (2)

  • Haemoglobin levels

    Month 6

  • Mircera therapy (dosage, schedule, mode of application) in the treatment of anemia in clinical practice

    Month 6

Secondary Outcomes (6)

  • Change in haemoglobin/haematocrit

    from baseline to Month 12

  • Biological parameters of anemia: transferrin saturation, serum ferritin, folates

    12 months

  • Efficacy of dialysis (Kt/V, urea levels)

    12 months

  • Safety: Incidence of adverse events

    12 months

  • Compliance (treatment modification or discontinuation)

    12 months

  • +1 more secondary outcomes

Study Arms (1)

Cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with chronic kidney disease on dialysis

You may qualify if:

  • Adult patients, \>/= 18 years of age
  • Chronic kidney disease, on dialysis for \> 3 months
  • Treatment-naïve or previous treatment with ESA
  • Initiation of treatment with Mircera for renal insufficiency associated anemia by decision of the treating physician

You may not qualify if:

  • Participation in a clinical trial
  • Anemia due to an associated malignant pathology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Neuilly-sur-Seine, 92521, France

Location

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 28, 2010

First Posted

October 4, 2010

Study Start

March 1, 2010

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

November 2, 2016

Record last verified: 2016-11

Locations

FR(1)