Clinical trial NCT01748396: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Kidney Disease Stage 3
Keywords: FGF-23
Calcitriol
Calcium carbonate
CKD Stage 3
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2012-12-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Percent changes in FGF-23
timeFrame: 8 weeks after administration
Secondary outcomes:
measure: Percent changes in Ca
timeFrame: 8 weeks after administration
measure: Percent changes in P
timeFrame: 8 weeks after administration
measure: Percent changes in iPTH
timeFrame: 8 weeks after administration
measure: Percent changes in 25(OH)D
timeFrame: 8 weeks after administration
measure: Percent changes in 1,25(OH)2D
timeFrame: 8 weeks after administration
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Yon Su Kim, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: College of Pharmacy, Seoul National University
name: Jung Mi Oh, Pharm.D.
role: STUDY_CHAIR
References: