Effect of Phosphate Binders on FGF-23 With Concurrent Calcitriol - Full Text View

Purpose

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


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Effect of Phosphate Binders on FGF-23 During Calcitriol Administration in CKD Stage 3 Patients

Resource links provided by NLM:

MedlinePlus related topics: Calcium Kidney Diseases

Drug Information available for: Calcium Gluconate Calcium carbonate Calcitriol

U.S. FDA Resources

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:

Percent changes in FGF-23 [ Time Frame: 8 weeks after administration ] [ Designated as safety issue: No ]
Comparison of percent changes in FGF-23 from baseline

Secondary Outcome Measures:

Percent changes in Ca [ Time Frame: 8 weeks after administration ] [ Designated as safety issue: No ]
Comparison of percent change in Ca from baseline
Percent changes in P [ Time Frame: 8 weeks after administration ] [ Designated as safety issue: No ]
Comparison of percent change in P from baseline
Percent changes in iPTH [ Time Frame: 8 weeks after administration ] [ Designated as safety issue: No ]
Comparison of percent change in intact parathyroid hormone from baseline
Percent changes in 25(OH)D [ Time Frame: 8 weeks after administration ] [ Designated as safety issue: No ]
Comparison of percent change in 25(OH)D from baseline
Percent changes in 1,25(OH)2D [ Time Frame: 8 weeks after administration ] [ Designated as safety issue: No ]
Comparison of percent change in 1,25(OH)2D from baseline


Enrollment:	30
Study Start Date:	July 2012
Study Completion Date:	January 2013
Primary Completion Date:	January 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility


Ages Eligible for Study:	18 Years to 70 Years (Adult, Senior)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01748396

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


Responsible Party:	Yon Su Kim, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier:	NCT01748396 History of Changes
Other Study ID Numbers:	SNUH-FGF23
Study First Received:	December 8, 2012
Last Updated:	February 14, 2013
Health Authority:	Korea: Institutional Review Board

Keywords provided by 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	Calcium Channel Agonists Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Vasoconstrictor Agents Vitamins Micronutrients Growth Substances Antacids Gastrointestinal Agents

ClinicalTrials.gov processed this record on September 23, 2016