CompletedPhase 4

A Study of Mircera (C.E.R.A.) in Patients With Pre-Dialysis Chronic Renal Anemia

Egypt70 participantsStarted 2011-07-18

Plain-language summary

This single arm, open label, multicenter study will evaluate the safety and change in hemoglobin levels of Mircera (C.E.R.A.; methoxy polyethylene glycol-epoetin beta) in patients with chronic renal anemia who are not on dialysis. Patients will receive as a recommended starting dose 1.2 micrograms of Mircera subcutaneously every 4 weeks. The starting dose is dependent on the patient's weight. Dose adjustment may be required due to inadequate or excessive treatment response. The anticipated time on study treatment is 28 weeks.

Who can participate

Age range18 Years

SexALL

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

Inclusion Criteria: * Adult patients, age \>/=18 years * Diagnosis of chronic renal anemia * Not on dialysis * Hemoglobin concentration \<10 g/dl * No erythropoiesis stimulating agent (ESA) therapy during the 3 months before study start * Estimated glomerular filtration rate (EGFR) \<60 ml/min and \>/=20 ml/min * Adequate iron status Exclusion Criteria: * Transfusion of red blood cells during the previous 2 months * Poorly controlled hypertension * Significant acute or chronic bleeding, e.g. gastrointestinal bleeding * Active malignant disease (except non-melanoma skin cancer) * Hemolysis * Hemoglobinopathies, e.g. sickle-cell disease, thalassemia

What they're measuring

Change From Baseline in Mean Hb Concentration at Week 20

Timeframe: Baseline (Week 0), Week 20

Change From Baseline in Mean Hb Concentration at Week 24

Timeframe: Baseline (Week 0), Week 24

Change From Baseline in Mean Hb Concentration at Week 28

Timeframe: Baseline (Week 0), Week 28

Trial details

NCT IDNCT01342640

SponsorHoffmann-La Roche

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2012-11-30

Results submitted2015-09-28