Effect of Phosphate Binders on FGF-23 With Concurrent Calcitriol

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yon Su Kim, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01748396
First received: December 8, 2012
Last updated: February 14, 2013
Last verified: February 2013
  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:


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
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

No publications provided

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 Carbonate
Calcitriol
Antacids
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Calcium Channel Agonists
Membrane Transport Modulators
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on September 18, 2014