Effect of Phosphate Binders on FGF-23 With Concurrent Calcitriol
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Calcitriol + CaCO3 Calcitriol 0.25mcg 1cap daily for 8 weeks, and Calcium Carbonate 500mg 1tab 3 times daily for 8 weeks |
Drug: Calcitriol
Drug: Calcium Carbonate
|
| Active Comparator: Calcitriol Calcitriol 0.25mcg 1cap daily for 8 weeks |
Drug: Calcitriol
|
Outcome Measures
Primary Outcome Measures
- Percent changes in FGF-23 [8 weeks after administration]
Comparison of percent changes in FGF-23 from baseline
Secondary Outcome Measures
- 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
Eligibility Criteria
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)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Seoul National University Hospital | Seoul | Korea, Republic of | 110-744 |
Sponsors and Collaborators
- Seoul National University Hospital
Investigators
- Principal Investigator: Yon Su Kim, M.D., Ph.D., Seoul National University Hospital
- Study Chair: Jung Mi Oh, Pharm.D., College of Pharmacy, Seoul National University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SNUH-FGF23