Effect of Phosphate Binders on FGF-23 With Concurrent Calcitriol

Study Overview
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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.

Official Title
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Effect of Phosphate Binders on FGF-23 During Calcitriol Administration in CKD Stage 3 Patients

Conditions
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Chronic Kidney Disease Stage 3

Intervention / Treatment
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* Drug: Calcitriol
* Drug: Calcium Carbonate


Participation Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Calcitriol + CaCO3<br>Calcitriol 0.25mcg 1cap daily for 8 weeks, and Calcium Carbonate 500mg 1tab 3 times daily for 8 weeks | Drug: Calcitriol<br> <br> Drug: Calcium Carbonate<br> <br> |
| Active Comparator: Calcitriol<br>Calcitriol 0.25mcg 1cap daily for 8 weeks | Drug: Calcitriol<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent changes in FGF-23 | Comparison of percent changes in FGF-23 from baseline | 8 weeks after administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent changes in Ca | Comparison of percent change in Ca from baseline | 8 weeks after administration | 
| Percent changes in P | Comparison of percent change in P from baseline | 8 weeks after administration | 
| Percent changes in iPTH | Comparison of percent change in intact parathyroid hormone from baseline | 8 weeks after administration | 
| Percent changes in 25(OH)D | Comparison of percent change in 25(OH)D from baseline | 8 weeks after administration | 
| Percent changes in 1,25(OH)2D | Comparison of percent change in 1,25(OH)2D from baseline | 8 weeks after administration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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FGF-23, Calcitriol, Calcium carbonate, CKD Stage 3