chronic renal failure patients
Conditions
Interventions
Group A:lanthanum carbonate
Group B:lanthanum carbonate placebo
Sponsors
Changzheng Hospital of Shanghai
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Chronic renal failure patients under hemodialyzing or continuous ambulatory peritoneal dialysis for at least 3 months; 2. Age between 18-70, both sexes; 3. Serum phosphate > 5.5mg/dL (1.78mmol/L) at the end of wash out period; 4. Having given informed consent.
Exclusion criteria
Exclusion criteria: 1. Bad food compliance; 2. Known anaphylactic reaction to Lanthanum; 3. Severe heart failure (NYHA III/IV); 4. Severe gastro- intestinal dysfunctions which may interfere with the effects of study drug or control drug, e.g. uncontrolled peptic ulcer, Crohn's disease, ulcerative colitis; 5. Pregnant or breast feeding female patients; 6. Hypercalcemia with serum calcium >=2.60mmol/L (10.4mg/dl) or hypocalcemia with serum calcium 1000pg/ml; 8. Having taken part in other clinical trial in recent 1 months; 9. Severe liver dysfunction with Total bilirubin, AST or ALT is more than 2.5 times of normal range; 10. Patients with a life threatening malignancy; 11. Patients who are known to be HIV positive; 12. Investigators have evaluated that patients condition is not suitable to participate the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum calcium, PTH and calcium-phosphorus product at each week of maintenance; | — |
Secondary
| Measure | Time frame |
|---|---|
| The serum phosphate level change compared with baseline;The serum phosphate level at each week of titration and maintenance;The percentage (%) of cases whose serum phosphate;The percentage (%) of cases who is responsive to the drugs; | — |
Countries
China
Contacts
Public ContactChanglin Mei
Outcome results
None listed