NCT01892202

Brief Summary

This multicenter observational study will evaluate the efficacy and safety of Mircera (methoxy polyethylene glycol-epoetin beta) in patients with chronic kidney disease not on dialysis in routine clinical practice. Eligible patients treated with Mircera for chronic renal anemia according to the standard of care and in line with the current local label will be followed for 6 months.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2011

Status
unknown

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

February 1, 2011

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

June 27, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 4, 2013

Completed
Last Updated

October 27, 2016

Status Verified

October 1, 2016

Enrollment Period

Same day

First QC Date

June 27, 2013

Last Update Submit

October 26, 2016

Conditions

Anemia

Interventions

CohortOTHER

Eligibility Criteria

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

You may qualify if:

  • Adult patients, 18 to 65 years of age inclusive
  • Patients with chronic kidney disease Stage III-IV not on dialysis
  • Hb \< 10 g/dL (for correction of anemia) or Hb 10-12 g/dL and receiving any other ESA (for maintenance of Hb levels)
  • Adequate iron status as judged by the treating physician

You may not qualify if:

  • Hypersensitivity to recombinant human erythropoietin, polyethylene glycol or to any constituent of the study medication
  • Significant acute or chronic bleeding
  • Hemoglobinopathies (e.g. homozygous sickle-cell disease, thalassemia of all types)
  • Active malignant disease during the last five years (except non-melanoma skin cancer)
  • Uncontrolled or symptomatic secondary hyperparathyroidism
  • Epileptic seizure during the last 6 months
  • Poorly controlled hypertension (sitting blood pressure \> 170/100 mmHG)
  • Myocardial infarction or stroke, or severe or unstable CAD
  • Severe liver disease during the previous 6 months
  • Congestive heart failure NYHA Class III-IV
  • Diagnosis or suspicion of pure red cell aplasia (PRCA)
  • Planned elective surgery during the study period (except cataract surgery and vascular access surgery)
  • Transfusion of red blood cells during the previous 2 months
  • Pregnant women
  • Any contra-indications to Mircera

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Anemia

Interventions

Cohort Studies

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic StudiesEpidemiologic Study CharacteristicsEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Study Design

Study Type
expanded access
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2013

First Posted

July 4, 2013

Study Start

February 1, 2011

Primary Completion

February 1, 2011

Study Completion

February 1, 2011

Last Updated

October 27, 2016

Record last verified: 2016-10