Combination Therapy of Lanthanum Carbonate and Calcium Carbonate: COLC Study

UMIN ID: UMIN000001852

Registered date:06/04/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Hemodialysis patients with hyperphosphatemia
• Date of first enrollment: 2009/04/01
• Target sample size: 50
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Each subject will orally receive Ca carbonate (continue dosage of a baseline) three times daily after meals for 16 weeks. Lanthanum carbonate 250-750mg will also be administered orally three times daily after meals for 16 weeks.

Outcome(s)

• Primary Outcome: To evaluate the target achievement rate of P<=6.0 mg/dL under combination therapy with Ca carbonate and La carbonate
• Secondary Outcome: P, Ca, CaxP product, intact-PTH, CRP, Nutrition Index (albumin, nPCR), Bone metabolism marker (ALP, BAP, TRAP5b), P regulating factor (FGF-23), Safety and tolerability at baseline, 4, 8, 12 and 16 week aftrer combination with Ca carbonate and La carbonate

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1) Pts with cancer or suspicious for cancer 2) Pregnant or possibly pregnant pts, pts on lactation 3) Pts who have obvious gastrointestinal disease(active peptic ulcer, ulcerative colitis, crohn disease, intestinal stenosis) 4) Pts who have severe hepatic dysfunction Pts who are treated with Sevelamer (terminate Sevelamer before 3 wks Inappropriate pts for this study according to the investigator's judgment

Related Information

• Primary Sponsor: COLC Study Research group
• Source(s) of Monetary Support: Public Health Research Foundation, Japan