NCT01309295

Brief Summary

This prospective observational study will assess the efficacy and safety of Mircera (methoxy polyethylene glycol-epoetin beta) in clinical practice in patients with chronic kidney disease, in pre-dialysis or on dialysis, initiated on Mircera treatment. Data from each patient will be collected over 12 months of treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 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

November 1, 2010

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 3, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 7, 2011

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

November 2, 2016

Status Verified

November 1, 2016

Enrollment Period

2 years

First QC Date

March 3, 2011

Last Update Submit

November 1, 2016

Conditions

Anemia, Kidney Disease, Chronic

Outcome Measures

Primary Outcomes (3)

  • Achievement of target hemoglobin (Hb) range of 10-12 g/dL according to Kidney Disease Outcomes Quality Initiative (KDQOI) guidelines

    2 years

  • Maintenance of target Hb range (10-12 g/dL)

    2 years

  • Safety: Incidence of adverse events

    2 years

Secondary Outcomes (4)

  • Correlation between baseline clinical variables and time on target Hb level

    2 years

  • Dosing pattern in clinical practice, including dose adaptations

    2 years

  • Frequency of visits and laboratory assessments

    2 years

  • Effect of compliance to treatment on Hb levels

    2 years

Study Arms (1)

Cohort

Eligibility Criteria

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

Chronic kidney disease patients initiated on Mircera treatment

You may qualify if:

  • Adult patients, \>/= 18 years of age
  • Chronic kidney disease, in pre-dialysis or dialysis
  • Appropriate for treatment with Mircera according to current guidelines and Summary of Product Characteristics

You may not qualify if:

  • Anemia due to non-renal causes
  • Pregnant or lactating women
  • Uncontrolled hypertension
  • Known hypersensitivity to methoxy polyethylene glycol-epoetin beta

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Tirana, 1000, Albania

Location

MeSH Terms

Conditions

AnemiaKidney DiseasesBronchiolitis Obliterans Syndrome

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesOrganizing PneumoniaBronchiolitis ObliteransBronchiolitisBronchitisBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesGraft vs Host DiseaseImmune System 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

March 3, 2011

First Posted

March 7, 2011

Study Start

November 1, 2010

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

November 2, 2016

Record last verified: 2016-11

Locations

AL(1)