Effect of Phosphate Binders on FGF-23 With Concurrent Calcitriol

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

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2013-01-31

Brief Summary

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Chronic kidney disease (CKD) is an established risk factor for cardiovascular morbidity and mortality, as shown by common manifestations of left ventricular hypertrophy (LVH) and arterial calcifications in CKD patients. Fibroblast growth factor-23(FGF-23) is a recently identified phosphaturic hormone that has been reported to be associated with the development of secondary hyperparathyroidism, cardiovascular morbidity, mortality, CKD progression.

While vitamin D is the mainstay therapy in CKD mineral bone disease (CKD-MBD), increased FGF-23 levels have been reported with vitamin D administration. The purpose of this study was to investigate the effect of calcium carbonate when used in conjunction with calcitriol on FGF-23.

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Detailed Description

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Conditions

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Chronic Kidney Disease Stage 3

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Calcitriol + CaCO3

Calcitriol 0.25mcg 1cap daily for 8 weeks, and Calcium Carbonate 500mg 1tab 3 times daily for 8 weeks

Group Type EXPERIMENTAL

Calcitriol

Intervention Type DRUG

Calcium Carbonate

Intervention Type DRUG

Calcitriol

Calcitriol 0.25mcg 1cap daily for 8 weeks

Group Type ACTIVE_COMPARATOR

Calcitriol

Intervention Type DRUG

Interventions

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Calcitriol

Intervention Type DRUG

Calcium Carbonate

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Adults of 18\~70 years of age
* CKD stage 3 patients (GFR: 30-60ml/min/1.73m2)
* Patients who've given consent to the trial

Exclusion Criteria

* Known allergy to Vitamin D or calcium carbonate
* Administration of vitamin D analogue or phosphate binders 3 months prior to study entry
* History of hypercalcemia (corrected serum calcium \> 10.5 mg/dL) or hypophosphatemia (serum phosphate \< 2.5 mg/dL) 3 months prior to study entry
* Patients with bone pathologies or diseases requiring vitamin D therapy that is unrelated to CKD-MBD
* Administration of concurrent medication , diseases, or history of surgeries that may affect bone-mineral metabolism or alter bone status
* Patients diagnosed with rapidly progressive glomerulonephritis(RPGN) or those in need of renal replacement therapy
* Patients with obstructive bowel diseases, or severe gastrointestinal diseases
* Patients with less than 2 years of life expectancy(ex. Malignancy diseases)

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No