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Effect of Phosphate Binders on FGF-23 With Concurrent Calcitriol

Primary Purpose

Chronic Kidney Disease Stage 3

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Calcitriol
Calcium Carbonate
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Disease Stage 3 focused on measuring FGF-23, Calcitriol, Calcium carbonate, CKD Stage 3

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Calcitriol + CaCO3

Calcitriol

Arm Description

Calcitriol 0.25mcg 1cap daily for 8 weeks, and Calcium Carbonate 500mg 1tab 3 times daily for 8 weeks

Calcitriol 0.25mcg 1cap daily for 8 weeks

Outcomes

Primary Outcome Measures

Percent changes in FGF-23
Comparison of percent changes in FGF-23 from baseline

Secondary Outcome Measures

Percent changes in Ca
Comparison of percent change in Ca from baseline
Percent changes in P
Comparison of percent change in P from baseline
Percent changes in iPTH
Comparison of percent change in intact parathyroid hormone from baseline
Percent changes in 25(OH)D
Comparison of percent change in 25(OH)D from baseline
Percent changes in 1,25(OH)2D
Comparison of percent change in 1,25(OH)2D from baseline

Full Information

First Posted
December 8, 2012
Last Updated
February 14, 2013
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01748396
Brief Title
Effect of Phosphate Binders on FGF-23 With Concurrent Calcitriol
Official Title
Effect of Phosphate Binders on FGF-23 During Calcitriol Administration in CKD Stage 3 Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease Stage 3
Keywords
FGF-23, Calcitriol, Calcium carbonate, CKD Stage 3

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Calcitriol + CaCO3
Arm Type
Experimental
Arm Description
Calcitriol 0.25mcg 1cap daily for 8 weeks, and Calcium Carbonate 500mg 1tab 3 times daily for 8 weeks
Arm Title
Calcitriol
Arm Type
Active Comparator
Arm Description
Calcitriol 0.25mcg 1cap daily for 8 weeks
Intervention Type
Drug
Intervention Name(s)
Calcitriol
Intervention Type
Drug
Intervention Name(s)
Calcium Carbonate
Primary Outcome Measure Information:
Title
Percent changes in FGF-23
Description
Comparison of percent changes in FGF-23 from baseline
Time Frame
8 weeks after administration
Secondary Outcome Measure Information:
Title
Percent changes in Ca
Description
Comparison of percent change in Ca from baseline
Time Frame
8 weeks after administration
Title
Percent changes in P
Description
Comparison of percent change in P from baseline
Time Frame
8 weeks after administration
Title
Percent changes in iPTH
Description
Comparison of percent change in intact parathyroid hormone from baseline
Time Frame
8 weeks after administration
Title
Percent changes in 25(OH)D
Description
Comparison of percent change in 25(OH)D from baseline
Time Frame
8 weeks after administration
Title
Percent changes in 1,25(OH)2D
Description
Comparison of percent change in 1,25(OH)2D from baseline
Time Frame
8 weeks after administration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yon Su Kim, M.D., Ph.D.
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jung Mi Oh, Pharm.D.
Organizational Affiliation
College of Pharmacy, Seoul National University
Official's Role
Study Chair
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of

12. IPD Sharing Statement

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Effect of Phosphate Binders on FGF-23 With Concurrent Calcitriol

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