The Effect of Lanthanum Carbonate on Fibroblast Growth Factor 23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2014-07-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Other Nonspecific Abnormal Serum Enzyme Levels

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Lanthanum carbonate

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

Group Type ACTIVE_COMPARATOR

Lanthanum carbonate

Intervention Type DRUG

the effect on serum FGF23

Calcium carbonate

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

Group Type ACTIVE_COMPARATOR

Calcium Carbonate

Intervention Type DRUG

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

Interventions

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Lanthanum carbonate

the effect on serum FGF23

Intervention Type DRUG

Calcium Carbonate

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

Intervention Type DRUG

Other Intervention Names

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Fosrenol TOP-CAL(CaCO3)

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No