NCT01748396

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jul 2012

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 8, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 12, 2012

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

February 18, 2013

Status Verified

February 1, 2013

Enrollment Period

6 months

First QC Date

December 8, 2012

Last Update Submit

February 14, 2013

Conditions

Chronic Kidney Disease Stage 3

Keywords

FGF-23CalcitriolCalcium carbonateCKD Stage 3

Outcome Measures

Primary Outcomes (1)

  • Percent changes in FGF-23

    Comparison of percent changes in FGF-23 from baseline

    8 weeks after administration

Secondary Outcomes (5)

  • Percent changes in Ca

    8 weeks after administration

  • Percent changes in P

    8 weeks after administration

  • Percent changes in iPTH

    8 weeks after administration

  • Percent changes in 25(OH)D

    8 weeks after administration

  • Percent changes in 1,25(OH)2D

    8 weeks after administration

Study Arms (2)

Calcitriol + CaCO3

EXPERIMENTAL

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

Drug: CalcitriolDrug: Calcium Carbonate

Calcitriol

ACTIVE COMPARATOR

Calcitriol 0.25mcg 1cap daily for 8 weeks

Drug: Calcitriol

Interventions

CalcitriolDRUG
CalcitriolCalcitriol + CaCO3
Calcium CarbonateDRUG
Calcitriol + CaCO3

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Related Publications (1)

  • Natale P, Green SC, Ruospo M, Craig JC, Vecchio M, Elder GJ, Strippoli GF. Phosphate binders for preventing and treating chronic kidney disease-mineral and bone disorder (CKD-MBD). Cochrane Database Syst Rev. 2025 Jun 27;6(6):CD006023. doi: 10.1002/14651858.CD006023.pub4.

    PMID: 40576086DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

CalcitriolCalcium Carbonate

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DihydroxycholecalciferolsHydroxycholecalciferolsCholecalciferolCholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipidsCalcium CompoundsInorganic ChemicalsCarbonatesCarbonic AcidCarbon Compounds, InorganicMinerals

Study Officials

  • Yon Su Kim, M.D., Ph.D.

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

  • Jung Mi Oh, Pharm.D.

    College of Pharmacy, Seoul National University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 8, 2012

First Posted

December 12, 2012

Study Start

July 1, 2012

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

February 18, 2013

Record last verified: 2013-02

Locations

KR(1)