An open, randomized, parallel group, multi-center study on the effect of a resume of Renal Anemia Treatment by Erythropoietin supplemented with Iron and vitamin C on the Prognosis in Hemodialysis Patients

UMIN ID: C000000316

Registered date:12/04/2006

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Renal anemia in maintenance dialysis patients
• Date of first enrollment: 2006/02/01
• Target sample size: 450
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Protocolized treatment for renal anemia that was proposed by ACTIVE study group. Doses of erythropoietin, iron and vitamin C were changed every month by serum ferritin level and Hb concentration according to ACTIVE protocol.
Conventional therapy for renal anemia; Attending physician determined the doses of erythropoietin and iron.

Outcome(s)

• Primary Outcome: 1) required doses of erythropoietin and iron for maintaining Hb level>11 g/dl 2) nutritional state 3) cardiovascular event, 4) hospitaization, 5)survival rate

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude criteria: 1) Patients with malignancy, infection and severe liver and lung diseases, 2)Patients receiving steroids and immunosuppressants

Related Information

• Primary Sponsor: Department of Kidney and Dialysis, Hyogo College of Medicine
• Source(s) of Monetary Support: Department account fund