Effect of Phosphate Binders on FGF-23 With Concurrent Calcitriol

Seoul National University

Status and phase: Completed; Phase 4

Conditions: Chronic Kidney Disease Stage 3

Treatments: Drug: Calcitriol; Drug: Calcium Carbonate

Study type: Interventional

Funder types: Other

Identifiers

NCT01748396

SNUH-FGF23

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Calcitriol + CaCO3

Experimental group

Description:

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

Treatment:

Drug: Calcium Carbonate

Drug: Calcitriol

Calcitriol

Active Comparator group

Description:

Calcitriol 0.25mcg 1cap daily for 8 weeks

Treatment:

Drug: Calcitriol