Open label multi-center randomized parallel two-group comparison test of the effects of hemoglobin levels on cardiovascular complications, prognosis, and quality of life in chronic hemodialysis patients

UMIN ID: C000000386

Registered date:01/04/2006

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Patients on hemodialysis therapy due to end-stage renal failure
• Date of first enrollment: 2006/07/01
• Target sample size: 150
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Adjust doses of iron erythropoietin to maintain hemoglobin level between 9.0 to 10.5 g/dl
Adjust doses of iron and erythropoietin to maintain hemoglobin level between 11.0 to 12.0 g/dl

Outcome(s)

• Primary Outcome: 1) Patient death by any cause including accidental death and every kind of complications. 2) Newly diagnosed ischemic heart diseases: acute myocardial infarction, coronary heart disease diagnosed by coronary arteriography, percutaneous coronary intervention, coronary artery bypass grafting 3) Shunt failure: any procedures for reconstruction of A-V fistula due to decreased blood flow. 4) Newly diagnosed cereberovascular diseases: cerebral hemorrhage/infarction, subarachnoid hemorrhage 5) Newly diagnosed peripheral vessel disorders: intermittent claudication with definitive peripheral vascular disorders, newly developed ulcer or gangrene of extremities, delayed wound healing.
• Secondary Outcome: 1) Changes in sf36 scores 2) Changes in urine volume 3) Changes in left ventricular mass index measured by echocardiography 4) Changes in pulse wave velocity 5) Hospitalization due to any diseases including hospitalization for clinical evaluation of the newly developed diseases

Key inclusion & exclusion criteria

• Age minimum: 21years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude criteria: 1) Uncontrollable severe hypertension (systolic blood pressure >180 mmHg and/or diastolic blood pressure >110 mmHg) even with appropriate antihypertensive agents 2) Cardiovascular complication or shunt failure within 3 months 3) Malignant diseases 4) Patients contraindicated to erythropoietin or iron 5) Any patients who are considered to be inappropriate by physician

Related Information

• Primary Sponsor: Study group for appropriate hemoglobin level
• Source(s) of Monetary Support: self-funding