The Effect of Lanthanum Carbonate on Fibroblast Growth Factor 23

Phase 4

• Conditions: Other Nonspecific Abnormal Serum Enzyme Levels
• Interventions: Drug: Calcium Carbonate; Drug: Lanthanum carbonate

• 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.

Study Timeline

• Status Verified: 2011-08
• Study Start: 2011-08
• Study First Submitted: 2013-04-24
• Study First Submitted QC: 2013-05-01
• Last Update Submitted: 2013-05-01
• Study First Posted: 2013-05-03
• Last Update Posted: 2013-05-03
• Primary Completion: 2014-07
• Study Completion: 2014-07

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

Trial Locations

Locations (1)

Saint Mary's hospital-Lotung; 🇨🇳 Taipei, Taiwan