Hemodialysis patients with hyperphosphatemia
Conditions
Interventions
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 dai
Sponsors
COLC Study Research group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Hemodialysis patients 2) Duration of hemodialysis more than three month 3) Age >20 4) Serum P > 6.0mg/dL 5) Who takes Ca carbonate 6) Pts with written Informed Consent
Exclusion criteria
Exclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the target achievement rate of P<=6.0 mg/dL under combination therapy with Ca carbonate and La carbonate | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactShigeo Negi MD, PhD
Wakayama Medical University Division of Nephrology & Blood Purification Medicine
Outcome results
None listed