CompletedNot Applicable

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

Albania250 participantsStarted 2010-11

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * Anemia due to non-renal causes * Pregnant or lactating women * Uncontrolled hypertension * Known hypersensitivity to methoxy polyethylene glycol-epoetin beta

What they're measuring

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

Timeframe: 2 years

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

Timeframe: 2 years

Safety: Incidence of adverse events

Timeframe: 2 years

Trial details

NCT IDNCT01309295

SponsorHoffmann-La Roche

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2012-11

View on ClinicalTrials.gov More Anemia, Kidney Disease, Chronic trials