The Effect of Lanthanum Carbonate on Fibroblast Growth Factor 23
Phase 4
- Conditions
- Other Nonspecific Abnormal Serum Enzyme Levels
- Interventions
- Registration Number
- NCT01845090
- Lead Sponsor
- Camillians Saint Mary's Hospital Luodong
- Brief Summary
To compare the effect of lanthanum carbonate with calcium carbonate on serum FGF23 levels in hemodialysis patients.
- Detailed Description
The investigators enrolled patients on maintenance hemodialysis and randomized them to two groups. One group will receive lanthanum carbonate and another group will receive calcium carbonate. The investigators will compare serum FGF23 levels between two groups after they receive above medication for 6 months.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
- Age > 18 years old
- Chronic renal failure on maintenance hemodialysis 3 times a week for at least 3 months Serum calcium:8-10.5 mg/dL
- Serum phosphate:3.5-6 mg/dL(before washout period)
- Serum phosphate ≧6 mg/dL after washout period
- Serum i-PTH: 150-600 pg/mL
Exclusion Criteria
- Diabetes mellitus
- Post parathyroidectomy
- Life expectancy< 6 months
- Liver disease(hepatitis B,C or liver dysfunction)
- Severe gastrointestinal disorders or other severe comorbidity
- Poor compliance
- Intolerance to lanthanum or calcium carbonate
- Active infection
- Malnutrition(serum albumin<3 g/dL or clinical assessment)
- Kt/V< 1.2 (inadequate dialysis)
- Serum phosphate>7.5 mg/dL after washout period
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Calcium carbonate Calcium Carbonate Calcium carbonate 500mg\~1000 mg tid for 6 months Lanthanum carbonate Lanthanum carbonate Lanthanum carbonate 375mg\~750 mg tid for 6 months
- Primary Outcome Measures
Name Time Method serum level of fibroblast growth factor 6 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Saint Mary's hospital-Lotung
🇨🇳Taipei, Taiwan