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A Study of Once Monthly Intravenous Mircera for the Maintenance Treatment of Dialysis Patients With Chronic Renal Anemia.

NCT00737464

CompletedPhase 4

Sponsor: Hoffmann-La Roche

Conditions: Anemia

Interventions: methoxy polyethylene glycol-epoetin beta [Mircera]

Countries: India

This single arm study will evaluate the maintenance of hemoglobin levels, safety and tolerability of once-monthly intravenous administration of Mircera in dialysis patients with chronic renal anemia. Patients will receive intravenous Mircera (120, 200 or 360 micrograms) every four weeks depending on the previous dose of epoetin alfa administered in the week preceding first study drug administration. Patients will be treated for 12 weeks with follow up 2 weeks after the last treatment visit. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* male or female patients, \>=18 years of age;
* chronic renal anemia;
* Hb concentration 10.5g/dL - 12.5g/dL;
* continuous intravenous maintenance therapy with epoetin alfa at the same dosing interval during the previous 2 months.

Exclusion Criteria:

* blood transfusion within the previous 2 months;
* poorly controlled hypertension;
* significant acute or chronic bleeding;
* active malignant disease;
* congestive heart failure (NYHA Class IV).

Locations (17)

New Delhi, National Capital Territory of Delhi, India
Bangalore, India
Bangalore, India
Chennai, India
Chennai, India
Chennai, India
Guwahati, India
Hyderabad, India
Hyderabad, India
Kanpur, India
Kolkata, India
Meerut, India
Mohali, India
Mumbai, India
Mumbai, India
New Delhi, India
Pune, India