Effect of Phosphate Binders on FGF-23 With Concurrent Calcitriol

Phase 4

Completed

• Conditions: Chronic Kidney Disease Stage 3
• Interventions: Drug: Calcitriol; Drug: Calcium Carbonate

• Registration Number: NCT01748396
• Lead Sponsor: Seoul National University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-12-08
• Study First Submitted QC: 2012-12-11
• Study First Posted: 2012-12-12
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-14
• Last Update Posted: 2013-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Calcitriol + CaCO3	Calcitriol	Calcitriol 0.25mcg 1cap daily for 8 weeks, and Calcium Carbonate 500mg 1tab 3 times daily for 8 weeks
Calcitriol + CaCO3	Calcium Carbonate	Calcitriol 0.25mcg 1cap daily for 8 weeks, and Calcium Carbonate 500mg 1tab 3 times daily for 8 weeks
Calcitriol	Calcitriol	Calcitriol 0.25mcg 1cap daily for 8 weeks

Primary Outcome Measures

Name	Time	Method
Percent changes in FGF-23	8 weeks after administration	Comparison of percent changes in FGF-23 from baseline

Secondary Outcome Measures

Name	Time	Method
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
Percent changes in 1,25(OH)2D	8 weeks after administration	Comparison of percent change in 1,25(OH)2D from baseline

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of