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Effect of Phosphate Binders on FGF-23 With Concurrent Calcitriol

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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

Tracking Information
First Submitted Date  ICMJE December 8, 2012
First Posted Date  ICMJE December 12, 2012
Last Update Posted Date February 18, 2013
Study Start Date  ICMJE July 2012
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 11, 2012)
Percent changes in FGF-23 [ Time Frame: 8 weeks after administration ]
Comparison of percent changes in FGF-23 from baseline
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 11, 2012)
  • Percent changes in Ca [ Time Frame: 8 weeks after administration ]
    Comparison of percent change in Ca from baseline
  • Percent changes in P [ Time Frame: 8 weeks after administration ]
    Comparison of percent change in P from baseline
  • Percent changes in iPTH [ Time Frame: 8 weeks after administration ]
    Comparison of percent change in intact parathyroid hormone from baseline
  • Percent changes in 25(OH)D [ Time Frame: 8 weeks after administration ]
    Comparison of percent change in 25(OH)D from baseline
  • Percent changes in 1,25(OH)2D [ Time Frame: 8 weeks after administration ]
    Comparison of percent change in 1,25(OH)2D from baseline
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Phosphate Binders on FGF-23 With Concurrent Calcitriol
Official Title  ICMJE Effect of Phosphate Binders on FGF-23 During Calcitriol Administration in CKD Stage 3 Patients
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chronic Kidney Disease Stage 3
Intervention  ICMJE
  • Drug: Calcitriol
  • Drug: Calcium Carbonate
Study Arms  ICMJE
  • Experimental: Calcitriol + CaCO3
    Calcitriol 0.25mcg 1cap daily for 8 weeks, and Calcium Carbonate 500mg 1tab 3 times daily for 8 weeks
    Interventions:
    • Drug: Calcitriol
    • Drug: Calcium Carbonate
  • Active Comparator: Calcitriol
    Calcitriol 0.25mcg 1cap daily for 8 weeks
    Intervention: Drug: Calcitriol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 11, 2012)
30
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2013
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01748396
Other Study ID Numbers  ICMJE SNUH-FGF23
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yon Su Kim, Seoul National University Hospital
Study Sponsor  ICMJE Seoul National University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Seoul National University Hospital
Verification Date February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP