A multi-center randomized control trial on Target hemoglobin for REnal function and clinical outcomes in Non-Dialysis patients in Japan (TREND-J Study)

UMIN ID: UMIN000001620

Registered date:15/01/2009

Basic Information

• Recruitment status: Complete: follow-up continuing
• Health condition(s) or Problem(s) studied: Chronic Kidney Disease(stage3/4/5,CKD)
• Date of first enrollment: 2009/01/01
• Target sample size: 900
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

C group:Hb level targeted to 10g/dL(within 9.5-10.5g/dL)
H group:Hb level targeted to 12g/dL(within 11.5-12.5g/dL) If patients with Hb level above 11.0g/dL are automatically allocated to H group

Outcome(s)

• Primary Outcome: Renal survival(time to creatinine doubling and renal replacement therapy, or death)
• Secondary Outcome: 1)achievement ratio to the targeted Hb levels 2)rate of change of eGFR 3)change of protein contents in urine(adjusted by creatinine) 4)hospitalization by cardiovascular diseases 5)change of cardiac functions(LVMI, EF) 6)QOL

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1)patients with anemia other than renal anemia(such as hematological disorders) 2)patients needed hospitalization by cardiovascular diseases within the past half year 3)patients with malignant tumor

Related Information

• Primary Sponsor: Division of Kidney and Hypertension,Department of Internal Medicine,Jikei University,School of Medicine.
• Source(s) of Monetary Support: The Jikei University, School of Medicine Division of Kidney and Hypertension, Department of Internal Medicine.