NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: UMIN000001852

Registered date:06/04/2009

Combination Therapy of Lanthanum Carbonate and Calcium Carbonate: COLC Study

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedHemodialysis patients with hyperphosphatemia
Date of first enrollment2009/04/01
Target sample size50
Countries of recruitmentJapan
Study typeInterventional
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 OutcomeTo evaluate the target achievement rate of P<=6.0 mg/dL under combination therapy with Ca carbonate and La carbonate
Secondary OutcomeP, 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 minimum20years-old
Age maximumNot applicable
GenderMale and Female
Include criteria
Exclude criteria1) 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

Contact

public contact
Name Shigeo Negi MD, PhD
Address 811-1, Kimiidera, Wakayama city Japan
Telephone 073-447-2300
E-mail shigeon@wakayama-med.ac.jp
Affiliation Wakayama Medical University Division of Nephrology & Blood Purification Medicine
scientific contact
Name Takashi Shigematsu MD, PhD
Address 811-1, Kimiidera, Wakayama city Japan
Telephone 073-447-2300
E-mail taki@wakayama-med.ac.jp
Affiliation Wakayama Medical University Division of Nephrology & Blood Purification Medicine