Prospective Study of hyperphosphatemia in CKD5D patients undergoing hemodialysis (STOP-HD).

UMIN ID: UMIN000002002

Registered date:25/05/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Hemodialysis patients with hyperphosphatemia
• Date of first enrollment: 2009/06/01
• Target sample size: 400
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Lanthanum carbonate 250-750mg will be administered orally three times daily after meals for 5 years.

Outcome(s)

• Primary Outcome: #Treatment status of phosphate binders and VitaminD #Measure aortic calcification (ACI) at baseline and after the treatment of La carbonate (maximum 5 years).
• Secondary Outcome: P,Ca, intact-PTH, Alb, Lipid, CRP, hepatic function, CTR, nPCR, vital sign, safety and tolerability at baseline and after the treatment of La carbonate (maximum 5 years).

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1) Patients with cancer or suspicious for cancer 2) Pregnant or possibly pregnant patients, patients on lactation 3) Patients who meet the contraindiation criteria in package insert of Lanthanum carbonate 4) Inappropriate patients for this study according to the investigator's judgment

Related Information

• Primary Sponsor: Phosphate Research group
• Source(s) of Monetary Support: The Waksman foundation of Japan inc.