Chronic Kidney Disease Stage 3
Conditions
Keywords
FGF-23, Calcitriol, Calcium carbonate, CKD Stage 3
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.
Interventions
DRUGCalcitriol
DRUGCalcium Carbonate
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent changes in FGF-23 | 8 weeks after administration | Comparison of percent changes in FGF-23 from baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent changes in 1,25(OH)2D | 8 weeks after administration | Comparison of percent change in 1,25(OH)2D from baseline |
| Percent changes in Ca | 8 weeks after administration | Comparison of percent change in Ca from baseline |
| Percent changes in P | 8 weeks after administration | Comparison of percent change in P from baseline |
| Percent changes in iPTH | 8 weeks after administration | Comparison of percent change in intact parathyroid hormone from baseline |
| Percent changes in 25(OH)D | 8 weeks after administration | Comparison of percent change in 25(OH)D from baseline |
Countries
South Korea
Outcome results
None listed