NCT01667380

Brief Summary

This observational study will evaluate the use and efficacy of Mircera (methoxy polyethylene glycol-epoetin beta) in anemia patients with chronic kidney disease (CKD) stage III-IV not on dialysis or CKD stage V on dialysis. Patients will be followed during 12 months of treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
78

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2012

Typical duration for all trials

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 13, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 17, 2012

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

November 2, 2016

Status Verified

November 1, 2016

Enrollment Period

3 years

First QC Date

August 13, 2012

Last Update Submit

November 1, 2016

Conditions

Anemia

Outcome Measures

Primary Outcomes (1)

  • Dosage/schedule of Mircera treatment in clinical practice

    approximately 3 years

Secondary Outcomes (2)

  • Proportion of patients with mean Hb level 10-12 g/dL 10 to 12 months after initiation of treatment

    approximately 3 years

  • Change in Hb levels

    from baseline to Month 12

Study Arms (1)

Cohort

Eligibility Criteria

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

Anemia patients with chronic kidney disease (CKD) stage III-IV not on dialysis or CKD stage V on dialysis

You may qualify if:

  • Adult patients, \>/= 18 years of age
  • Patients with chronic renal anemia with stage III-IV CKD not on dialysis and who are, in the opinion of the treating physician, not expected at baseline to require dialysis within 12 months
  • Patients with chronic renal anemia with stage V CKD on dialysis
  • No contraindication to ESA treatment

You may not qualify if:

  • Uncontrolled hypertension
  • Hypersensitivity to the active substance or any other of the excipients of Mircera and other ESAs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Podgorica, 81 000, Montenegro

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

August 13, 2012

First Posted

August 17, 2012

Study Start

April 1, 2012

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

November 2, 2016

Record last verified: 2016-11

Locations

MO(1)