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Effect of Phosphate Binders on FGF-23 With Concurrent Calcitriol

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01748396
Recruitment Status : Completed
First Posted : December 12, 2012
Last Update Posted : February 18, 2013
Sponsor:
Information provided by (Responsible Party):
Yon Su Kim, Seoul National University Hospital

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

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Arms and Interventions
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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, Older Adult)
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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01748396


Locations
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Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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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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Responsible Party: Yon Su Kim, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01748396    
Other Study ID Numbers: SNUH-FGF23
First Posted: December 12, 2012    Key Record Dates
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:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Calcitriol
Calcium Carbonate
Calcium
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
 Antacids
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents
Calcium Channel Agonists
Membrane Transport Modulators
Vasoconstrictor Agents
Vitamins
Micronutrients
Bone Density Conservation Agents