Effect of Phosphate Binders on FGF-23 With Concurrent Calcitriol

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Kidney Disease Stage 3
• Intervention / Treatment: Drug: Calcitriol; Drug: Calcium Carbonate

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 110-744
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent changes in FGF-23	Comparison of percent changes in FGF-23 from baseline	8 weeks after administration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent changes in Ca	Comparison of percent change in Ca from baseline	8 weeks after administration
Percent changes in P	Comparison of percent change in P from baseline	8 weeks after administration
Percent changes in iPTH	Comparison of percent change in intact parathyroid hormone from baseline	8 weeks after administration
Percent changes in 25(OH)D	Comparison of percent change in 25(OH)D from baseline	8 weeks after administration
Percent changes in 1,25(OH)2D	Comparison of percent change in 1,25(OH)2D from baseline	8 weeks after administration

Collaborators and Investigators

• Sponsor: 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 record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Actual): January 1, 2013
• Study Completion (Actual): January 1, 2013

Study Registration Dates

• First Submitted: December 8, 2012
• First Submitted That Met QC Criteria: December 11, 2012
• First Posted (Estimate): December 12, 2012

Study Record Updates

• Last Update Posted (Estimate): February 18, 2013
• Last Update Submitted That Met QC Criteria: February 14, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Keywords: FGF-23; Calcitriol; Calcium carbonate; CKD Stage 3
• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Gastrointestinal Agents; Micronutrients; Membrane Transport Modulators; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vasoconstrictor Agents; Antacids; Calcium Channel Agonists; Calcium; Calcium Carbonate; Calcitriol
• Other Study ID Numbers: SNUH-FGF23