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

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 - Multi-center randomized clinical studies of the effects of hemoglobin levels on cardiovascular complications in hemodialysis patients

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-C000000386

Enrollment

150

Registered

2006-04-01

Start date

2006-07-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients on hemodialysis therapy due to end-stage renal failure

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Male and female patients; age between 21 years old and 80 years old. Written informed consent must be obtained. Patients should be on hemodialysis for longer than 3 months and in stable medical condition.

Exclusion criteria

Exclusion 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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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

Measure	Time frame
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	—

Countries

Japan

Contacts

Public ContactMatsuhiko Hayashi

Keio University School of Medicine Department of Internal Medicine

matuhiko@sc.itc.keio.ac.jp03-5363-3878

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026