Effect of Phosphate Binders on FGF-23 During Calcitriol Administration in CKD Stage 3 Patients
Overview
- Phase
- Phase 4
- Intervention
- Calcitriol
- Conditions
- Chronic Kidney Disease Stage 3
- Sponsor
- Seoul National University Hospital
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Percent changes in FGF-23
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
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.
Investigators
Yon Su Kim
Professor
Seoul National University Hospital
Eligibility Criteria
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)
Arms & Interventions
Calcitriol
Calcitriol 0.25mcg 1cap daily for 8 weeks
Intervention: Calcitriol
Calcitriol + CaCO3
Calcitriol 0.25mcg 1cap daily for 8 weeks, and Calcium Carbonate 500mg 1tab 3 times daily for 8 weeks
Intervention: Calcitriol
Calcitriol + CaCO3
Calcitriol 0.25mcg 1cap daily for 8 weeks, and Calcium Carbonate 500mg 1tab 3 times daily for 8 weeks
Intervention: Calcium Carbonate
Outcomes
Primary Outcomes
Percent changes in FGF-23
Time Frame: 8 weeks after administration
Comparison of percent changes in FGF-23 from baseline
Secondary Outcomes
- Percent changes in Ca(8 weeks after administration)
- Percent changes in P(8 weeks after administration)
- Percent changes in iPTH(8 weeks after administration)
- Percent changes in 25(OH)D(8 weeks after administration)
- Percent changes in 1,25(OH)2D(8 weeks after administration)