Effect of Phosphate Binders on FGF-23 With Concurrent Calcitriol

Study Description

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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
Chronic Kidney Disease Stage 3	Drug: Calcitriol; Drug: Calcium Carbonate	Phase 4

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	30 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Effect of Phosphate Binders on FGF-23 During Calcitriol Administration in CKD Stage 3 Patients
Study Start Date :	July 2012
Actual Primary Completion Date :	January 2013
Actual Study Completion Date :	January 2013

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Primary Outcome Measures :

1. Percent changes in FGF-23 [ Time Frame: 8 weeks after administration ]
   Comparison of percent changes in FGF-23 from baseline

Secondary Outcome Measures :

1. Percent changes in Ca [ Time Frame: 8 weeks after administration ]
   Comparison of percent change in Ca from baseline
2. Percent changes in P [ Time Frame: 8 weeks after administration ]
   Comparison of percent change in P from baseline
3. Percent changes in iPTH [ Time Frame: 8 weeks after administration ]
   Comparison of percent change in intact parathyroid hormone from baseline
4. Percent changes in 25(OH)D [ Time Frame: 8 weeks after administration ]
   Comparison of percent change in 25(OH)D from baseline
5. Percent changes in 1,25(OH)2D [ Time Frame: 8 weeks after administration ]
   Comparison of percent change in 1,25(OH)2D from baseline

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 70 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Korea, Republic of
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

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Yon Su Kim, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier:	NCT01748396 History of Changes
Other Study ID Numbers:	SNUH-FGF23
First Posted:	December 12, 2012
Last Update Posted:	February 18, 2013
Last Verified:	February 2013

Keywords provided by Yon Su Kim, Seoul National University Hospital:

FGF-23; Calcitriol; Calcium carbonate; CKD Stage 3

Additional relevant MeSH terms:

Kidney Diseases; Renal Insufficiency, Chronic; Urologic Diseases; Renal Insufficiency; Calcium, Dietary; Calcitriol; Calcium Carbonate; Bone Density Conservation Agents; Physiological Effects of Drugs	Antacids; Molecular Mechanisms of Pharmacological Action; Gastrointestinal Agents; Calcium Channel Agonists; Membrane Transport Modulators; Vasoconstrictor Agents; Vitamins; Micronutrients; Growth Substances