An Observational Study of Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) as Maintenance Treatment in Patients With Chronic Renal Anemia on Haemodialysis

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

185 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-06-30

Study Completion Date

2014-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This prospective observational study will evaluate the safety and efficacy of Mircera (methoxy polyethylene glycol-epoetin beta) in patients with chronic renal anemia on haemodialysis in maintenance ESA treatment. Data will be collected from patients receiving once monthly Mircera according to standard of care and local labelling during 12 months of treatment.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

An Observational Study of Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) in Patients With Chronic Kidney Disease in Pre-Dialysis or Dialysis

NCT01309295

Anemia, Kidney Disease, Chronic

COMPLETED

An Observational Study of Mircera in Patients With Chronic Renal Anemia on Dialysis (CKD Stage V) or Not on Dialysis (CKD Stage III-IV)

NCT01667380

Anemia

COMPLETED

An Observational Study to Evaluate the Effectiveness of Mircera Treatment for Renal Anemia in Pre-dialysis Participants With Chronic Kideny Disease (CKD)

NCT02547454

Kidney Disease, Chronic

COMPLETED

A Study Of Mircera In Patients With Kidney Disease Who Are Not On Dialysis

NCT02490514

Renal Tubular Acidosis, Distal, With Hemolytic Anemia

COMPLETED

An Observational Study of Hemoglobin Stability in Chronic Kidney Disease Patients on Dialysis Treated With Mircera (Methoxy Polyethylene Glycol-epoetin Beta)

NCT01974271

Anemia

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Anemia, Kidney Disease, Chronic

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cohort

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Adult patients, \>/= 18 years of age
* Stage IV chronic kidney disease, on haemodialysis
* Chronic renal anemia, on maintenance ESA treatment
* Hemoglobin concentration between 10.0 an 12 g/dL
* Continuous maintenance epoetin therapy with the same dosing interval during the previous month

Exclusion Criteria

* Contraindications to ESA treatment (e.g. hypersensitivity, non-controlled hypertension)
* Hemoglobinopathies (e.g. homozygous sickle-cell disease, thalassemia of all types)
* Anemia due to hemolysis, pure red cell aplasia

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No