end-stage renal disease
Conditions
Interventions
Lanthanum carbonate treatment (Enrollment: 1 year, Follow-up: 3 years, Extension period: 2 years)
Calcium carbonate treatment ((Enrollment: 1 year, Follow-up: 3 years, Extension period: 2 years)
Sponsors
Department of Nephrology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Hemodialysis patients 2) SerumP>6.0mg/dl and taking Phosphate binder in Hyperphosphosphataemia. 3) Hemodialysis for more than 6 mo, less than 5 years 4) Men or women >=20 years of age 5) Patients with written IC
Exclusion criteria
Exclusion criteria: 1) Contraindications to Ca carbonate and La carbonate 2) Severe GI disorders 3) History of obstructed bowels 4) History of IHD/stroke within 6 mo before randomization 5) Severe congestive heart failure 6) Severe liver dysfunction (AST or ALT greater than 3 times the upper limit of normal, hepatic cirrhosis) 7) Severe malnutrition 8) Malignancy of any type within the last five years 9) Severe infectious disease within 3 mo before randomization 10) Pregnant or possibly pregnant women and women on lactation 11) Ineligible patients according to the investigators judgment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Abdominal aortic calcification (Progression of abdominal aortic calcification volume detected by computed tomography image for renal carcinoma screening) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Phosphorus and calcium level achievement rate as defined by the Japanese Society for Dialysis Therapy guideline 2) Incidence of hypercalcemia ( defined as corrected serum calcium>10.5mg/dl) 3) Incidence of secondary hyperparathyroidism (defined as i-PTH>240pg/ml) 4) Performance rate of PTx and PEIT 5) BAP(ALP), i-PTH, BAP/i-PTH 6) Arterial stiffness change (CAVI, PWV, ABI) 7) Safety | — |
Countries
Japan
Contacts
Public ContactHiromichi Suzuki
Saitama Medical School Department of Nephrology
Outcome results
None listed