Iron containing phosphate binder and iron metabolism

JRCT ID: jRCTs051190013

Registered date:09/05/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Chronic kidney disease
• Date of first enrollment: 02/05/2017
• Target sample size: 500
• Study type: Interventional

Intervention(s)

Arm A: According to the clinical practice guideline for the management of chronic kidney disease-mineral and bone disorder (JSDT 2012), treated with iron containing phosphate binder for 3 year.
Arm B: According to the clinical practice guideline for the management of chronic kidney disease-mineral and bone disorder (JSDT 2012),treated with non iron containing phosphate binder for 3 year.

Outcome(s)

• Primary Outcome: Adverse events (cerebral cardiovascular disease, infection, hospitalization) and survival.
• Secondary Outcome: The effect of iron containing phosphate binder on the anemia (Hb, Ret, RDW,dose of iron and ESA), iron metabolism(ferritin, TSAT, hepcidin, NTBI), CKD-MBD(Ca, P, FGF23,dose of phosphate binder, vitaminD, cinacalcet), arteriosclerosis (PWV, ABI, TMAO, LVMI), and microbiome.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both
• Include criteria: Maintenance hemodialysis patient with high serum phosphate level.

Exclude criteria

1) Patients who received maintenance hemodialysis for < 6month.
2) Patients with severe heart failure (>NYHA III), respiratory failure, malignancy disease, or severe liver dysfunction.
3) Patient with high serum ferritin level(>100 ng/mL) at the start of this study.

Related Information

• Primary Sponsor: Kuragano Takahiro
• Source(s) of Monetary Support: Kissei Pharmaceutical Co., Ltd.,Kissei Pharmaceutical., LTD
• Secondary ID(s): UMIN000023700