Chronic Kidney Disease Stage 3Phase 4NCT01748396
Effect of Phosphate Binders on FGF-23 With Concurrent Calcitriol
A Phase 4 study testing Calcitriol and Calcium Carbonate in people with Chronic Kidney Disease Stage 3, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Kidney Disease Stage 3
- What is being tested?
- Calcitriol and Calcium Carbonate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2012to Jan 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Phosphate Binders on FGF-23 During Calcitriol Administration in CKD Stage 3 Patients
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.
- Conditions
- Chronic Kidney Disease Stage 3
- Being tested
- Calcitriol, Calcium Carbonate
- Keywords
- FGF-23, Calcitriol, Calcium carbonate, CKD Stage 3
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CalcitriolDrug
Calcium CarbonateDrug
| Study group | Role | What they receive |
|---|---|---|
| Calcitriol + CaCO3 | Experimental | Calcitriol 0.25mcg 1cap daily for 8 weeks, and Calcium Carbonate 500mg 1tab 3 times daily for 8 weeks Receives: Drug: Calcitriol; Drug: Calcium Carbonate |
| Calcitriol | Active comparator | Calcitriol 0.25mcg 1cap daily for 8 weeks Receives: Drug: Calcitriol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent changes in FGF-23
Comparison of percent changes in FGF-23 from baseline
Measured: 8 weeks after administration
Secondary outcomes (5)
Percent changes in Ca
Comparison of percent change in Ca from baseline
Measured: 8 weeks after administration
Percent changes in P
Comparison of percent change in P from baseline
Measured: 8 weeks after administration
Percent changes in iPTH
Comparison of percent change in intact parathyroid hormone from baseline
Measured: 8 weeks after administration
Percent changes in 25(OH)D
Comparison of percent change in 25(OH)D from baseline
Measured: 8 weeks after administration
Percent changes in 1,25(OH)2D
Comparison of percent change in 1,25(OH)2D from baseline
Measured: 8 weeks after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2012 (estimated)
- Study startJul 2012
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney Disease Stage 3Studies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yon Su Kim, Seoul National University Hospital
- Investigators
- Yon Su Kim, M.D., Ph.D., Principal investigator, Seoul National University HospitalJung Mi Oh, Pharm.D., Study chair, College of Pharmacy, Seoul National University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01748396
- Sponsor's protocol ID
- SNUH-FGF23
- Status last verified
- Feb 2013
- First submitted
- 8 Dec 2012
- Last updated
- 18 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 40576086
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Phosphate Binders on FGF-23 During Calcitriol Administration in CKD Stage 3 Patients
- ClinicalTrials.gov ID
- NCT01748396
- Acronym / sponsor ID
- SNUH-FGF23
- Conditions
- Chronic Kidney Disease Stage 3
- Keywords
- FGF-23, Calcitriol, Calcium carbonate, CKD Stage 3
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 12 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Calcitriol + CaCO3 | Experimental | Drug: Calcitriol, Drug: Calcium CarbonateCalcitriol 0.25mcg 1cap daily for 8 weeks, and Calcium Carbonate 500mg 1tab 3 times daily for 8 weeks |
| Calcitriol | Active comparator | Drug: CalcitriolCalcitriol 0.25mcg 1cap daily for 8 weeks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Calcitriol | Drug | Calcitriol, Calcitriol + CaCO3 |
| Calcium Carbonate | Drug | Calcitriol + CaCO3 |
Primary outcome
Percent changes in FGF-23
Time frame: 8 weeks after administration
Comparison of percent changes in FGF-23 from baseline
5 secondary outcomes
Percent changes in Ca
Time frame: 8 weeks after administration
Percent changes in P
Time frame: 8 weeks after administration
Percent changes in iPTH
Time frame: 8 weeks after administration
Percent changes in 25(OH)D
Time frame: 8 weeks after administration
Percent changes in 1,25(OH)2D
Time frame: 8 weeks after administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2013.
- Derived from this study: PubMed 40576086Natale 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yon Su Kim, M.D., Ph.D. principal investigator
Seoul National University Hospital
Jung Mi Oh, Pharm.D. study chair
College of Pharmacy, Seoul National University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Calcitriol and Calcium Carbonate in people with Chronic Kidney Disease Stage 3, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent changes in FGF-23 (time frame: 8 weeks after administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01748396, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2013.