Effect of Phosphate Binders on FGF-23 With Concurrent Calcitriol

Chronic Kidney Disease Stage 3 Clinical Trial

Official title:

Effect of Phosphate Binders on FGF-23 During Calcitriol Administration in CKD Stage 3 Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01748396
• Other study ID #: SNUH-FGF23
• Status: Completed
• Phase: Phase 4
• First received: December 8, 2012
• Last updated: February 14, 2013
• Start date: July 2012
• Est. completion date: January 2013

Study information

• Verified date: February 2013
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Kidney Disease Stage 3
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• Calcitriol

• Calcium Carbonate

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent changes in FGF-23	Comparison of percent changes in FGF-23 from baseline	8 weeks after administration	No
Secondary	Percent changes in Ca	Comparison of percent change in Ca from baseline	8 weeks after administration	No
Secondary	Percent changes in P	Comparison of percent change in P from baseline	8 weeks after administration	No
Secondary	Percent changes in iPTH	Comparison of percent change in intact parathyroid hormone from baseline	8 weeks after administration	No
Secondary	Percent changes in 25(OH)D	Comparison of percent change in 25(OH)D from baseline	8 weeks after administration	No
Secondary	Percent changes in 1,25(OH)2D	Comparison of percent change in 1,25(OH)2D from baseline	8 weeks after administration	No