The Effect of Lanthanum Carbonate on Fibroblast Growth Factor 23

Camillians Saint Mary's Hospital Luodong

Status and phase: Unknown; Phase 4

Conditions: Other Nonspecific Abnormal Serum Enzyme Levels

Treatments: Drug: Calcium Carbonate; Drug: Lanthanum carbonate

Study type: Interventional

Funder types: Other

Identifiers

NCT01845090

SMHLANFGF23

Details and patient eligibility

About

To compare the effect of lanthanum carbonate with calcium carbonate on serum FGF23 levels in hemodialysis patients.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Lanthanum carbonate

Active Comparator group

Description:

Lanthanum carbonate 375mg\~750 mg tid for 6 months

Treatment:

Drug: Lanthanum carbonate

Calcium carbonate

Active Comparator group

Description:

Calcium carbonate 500mg\~1000 mg tid for 6 months

Treatment:

Drug: Calcium Carbonate