Effect of Phosphate Binders on FGF-23 With Concurrent Calcitriol
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| ClinicalTrials.gov Identifier: NCT01748396 |
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Recruitment Status :
Completed
First Posted : December 12, 2012
Last Update Posted : February 18, 2013
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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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Chronic Kidney Disease Stage 3 | Drug: Calcitriol Drug: Calcium Carbonate | Phase 4 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 30 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Effect of Phosphate Binders on FGF-23 During Calcitriol Administration in CKD Stage 3 Patients |
| Study Start Date : | July 2012 |
| Actual Primary Completion Date : | January 2013 |
| Actual Study Completion Date : | January 2013 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Calcitriol + CaCO3
Calcitriol 0.25mcg 1cap daily for 8 weeks, and Calcium Carbonate 500mg 1tab 3 times daily for 8 weeks
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Drug: Calcitriol Drug: Calcium Carbonate |
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Active Comparator: Calcitriol
Calcitriol 0.25mcg 1cap daily for 8 weeks
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Drug: Calcitriol |
- Percent changes in FGF-23 [ Time Frame: 8 weeks after administration ]Comparison of percent changes in FGF-23 from baseline
- 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
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| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01748396
| Korea, Republic of | |
| Seoul National University Hospital | |
| Seoul, Korea, Republic of, 110-744 | |
| 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 |
| Responsible Party: | Yon Su Kim, Professor, Seoul National University Hospital |
| ClinicalTrials.gov Identifier: | NCT01748396 History of Changes |
| Other Study ID Numbers: |
SNUH-FGF23 |
| First Posted: | December 12, 2012 Key Record Dates |
| Last Update Posted: | February 18, 2013 |
| Last Verified: | February 2013 |
Keywords provided by Yon Su Kim, Seoul National University Hospital:
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FGF-23 Calcitriol Calcium carbonate CKD Stage 3 |
Additional relevant MeSH terms:
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Kidney Diseases Renal Insufficiency, Chronic Urologic Diseases Renal Insufficiency Calcium, Dietary Calcitriol Calcium Carbonate Bone Density Conservation Agents Physiological Effects of Drugs |
Antacids Molecular Mechanisms of Pharmacological Action Gastrointestinal Agents Calcium Channel Agonists Membrane Transport Modulators Vasoconstrictor Agents Vitamins Micronutrients Growth Substances |