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

Non-interventional Study on the Use of Mircera in the Treatment of Chronic Renal Anemia in Patients With Chronic Kidney Disease Stages III-IV Not on Dialysis and in Patients on Stage V on Hemodialysis

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01667380

Enrollment

Registered

2012-08-17

Start date

2012-04-30

Completion date

2015-04-30

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Dosage/schedule of Mircera treatment in clinical practice	approximately 3 years

Secondary

Measure	Time frame
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

Countries

Montenegro

Outcome results