ProteinuriaPhase 4NCT01512862
Anti-proteinuric Effect of Calcitriol in Non-diabetic Kidney Disease Patients
A Phase 4 study testing Calcitriol in people with Proteinuria, run by Seoul National University Hospital at 3 sites in South Korea.
Trial summary
Proteinuria is not only a marker of chronic kidney disease (CKD) progression, but also a marker of cardiovascular disease and death. In previous studies, active vitamin D deficiency is associated with cardiovascular risk factors such as albuminuria, diabetes mellitus, and lower glomerular filtration rate (GFR). Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- Proteinuria
- What is being tested?
- Calcitriol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 3 sitesSouth Korea
- Study dates
- Jan 2012to Dec 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 19 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Nondiabetic kidney disease patients aged 19-70 years
- MDRD GFR ≥ 30 mL/min/1.73m2
- Patients with residual urine protein/creatinine ratio > 200 mg/g
- Adequate blood pressure control as treated systolic blood pressure <=140 or diastolic <=90 mmHg with RAS inhibitor for more than 3 months
- Normotensive patients untreated with RAS inhibitors
- Serum intact PTH as 35-500 mg/dL and serum calcium less than 10.2 mg/dL
- Patients who have not been treated vitamin D within the 3 months prior to signing the informed consent form
Who cannot join
- Patients with nephrotic-range proteinuria (24 hour urine protein >3.5 g/24 hr)
- Patients with rapidly progressive glomerulonephritis
- Patients requiring renal replacement therapy immediately
- Hypercalcemia (uncorrected serum calcium level > 10.2 mg/dL) within 3 months
- Malignant hypertension
- Heart failure (New York Heart Association [NYHA] functional class II to IV or LVEF less than 40%)
Show all 13Show fewer
- Severe chronic obstructive lung disease
- Decompensated liver disease
- Known allergy or hypersensitivity to vitamin D
- Current treatment with steroids and/or immunosuppressive agents
- No other active primary malignancy requiring treatment or that limits survival to ≤ 2 years
- History of noncompliance to medical regimen
- Inability to give an informed consent or to cooperate with researchers (e.g., psychiatric disorder)
Trial locations and contacts
3 sites in 1 country.
South Korea3 sites, 3 recruiting
- Enrolling by invitation
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707
- Recruiting
Seoul National University Hospital
Seoul, 110-744
Yon Su Kim, M.D., Ph.D., 82-2-2072-2264, yonsukim@snu.ac.kr
Dong Ki Kim, M.D., Ph.D., 82-2-2072-2303, dkkim73@gmail.com
- Enrolling by invitation
SMG-SNU Boramae Medical Center
Seoul, 156-707
About this study
Official title: Additive Renoprotective Effects of Oral Calcitriol in Nondiabetic Chronic Kidney Disease Patients
Proteinuria is not only a marker of chronic kidney disease (CKD) progression, but also a marker of cardiovascular disease and death. In previous studies, active vitamin D deficiency is associated with cardiovascular risk factors such as albuminuria, diabetes mellitus, and lower glomerular filtration rate (GFR). And calcitriol was shown to have a preventive effect in progressive glomerular damage in a renal ablation model. Calcitriol, an active form of vitamin D (1,25-dihydroxyvitamin-D3), is commonly used for the treatment of secondary hyperparathyroidism in patients with advanced chronic kidney diseases.
Therefore, the objective of this study is to evaluate the anti-proteinuric effect of calcitriol in non-diabetic kidney disease patients. They will be treated with calcitriol and placebo for 24 weeks and observed for 24 weeks after treatment. Proteinuria, renal function, serum and urinary inflammatory markers, and adverse event will be monitored.
- Conditions
- Proteinuria
- Being tested
- Calcitriol, Placebo
- Keywords
- Calcitriol, Off-label
- Medical subject headings
- Proteinuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CalcitriolDrug
Also called Calcio® (Hanmi Pharm Co., Korea)
Dosage of 0.25 mcg administered orally once daily for 6 weeks and dose escalated to 0.5 mcg orally once daily up to 6 months
PlaceboDrug
Dosage of 0.25 mcg administered orally once daily for 6 weeks and dose escalated to 0.5 mcg orally once daily up to 6 months
| Study group | Role | What they receive |
|---|---|---|
| Calcitriol | Experimental | Not described Receives: Drug: Calcitriol |
| Placebo | No intervention | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in proteinuria
Comparison of proteinuria amount checked by random urine protein/creatinine ratio
Measured: 6, 12 months after administration
Secondary outcomes (2)
Changes in renal function
Comparison of in serum creatinine level from baseline
Measured: 3, 6, 9 and 12 months
Changes in urinary renal damage markers
Comparison of urinary TGF-beta, TNF-alpha, MCP-1 level from baseline
Measured: 6, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionDec 2012 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ProteinuriaStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 240 participants (estimated)
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
- Jung Mi Oh, Pharm.D., Study chair, Seoul National Univerisy College of PharmacyYon Su Kim, M.D., Ph.D., Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01512862
- Sponsor's protocol ID
- SNUH-CCTO
- Status last verified
- Apr 2012
- First submitted
- 13 Jan 2012
- Last updated
- 10 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Additive Renoprotective Effects of Oral Calcitriol in Nondiabetic Chronic Kidney Disease Patients
- ClinicalTrials.gov ID
- NCT01512862
- Acronym / sponsor ID
- SNUH-CCTO
- Conditions
- Proteinuria
- Keywords
- Calcitriol, Off-label
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 19 Jan 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.
Proteinuria is not only a marker of chronic kidney disease (CKD) progression, but also a marker of cardiovascular disease and death. In previous studies, active vitamin D deficiency is associated with cardiovascular risk factors such as albuminuria, diabetes mellitus, and lower glomerular filtration rate (GFR). And calcitriol was shown to have a preventive effect in progressive glomerular damage in a renal ablation model. Calcitriol, an active form of vitamin D (1,25-dihydroxyvitamin-D3), is commonly used for the treatment of secondary hyperparathyroidism in patients with advanced chronic kidney diseases.
Therefore, the objective of this study is to evaluate the anti-proteinuric effect of calcitriol in non-diabetic kidney disease patients. They will be treated with calcitriol and placebo for 24 weeks and observed for 24 weeks after treatment. Proteinuria, renal function, serum and urinary inflammatory markers, and adverse event will be monitored.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Calcitriol | Experimental | Drug: Calcitriol |
| Placebo | No intervention | Drug: Placebo |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Nondiabetic kidney disease patients aged 19-70 years
- MDRD GFR ≥ 30 mL/min/1.73m2
- Patients with residual urine protein/creatinine ratio > 200 mg/g
- Adequate blood pressure control as treated systolic blood pressure <=140 or diastolic <=90 mmHg with RAS inhibitor for more than 3 months
- Normotensive patients untreated with RAS inhibitors
Key exclusion criteria (13 listed)
- Patients with nephrotic-range proteinuria (24 hour urine protein >3.5 g/24 hr)
- Patients with rapidly progressive glomerulonephritis
- Patients requiring renal replacement therapy immediately
- Hypercalcemia (uncorrected serum calcium level > 10.2 mg/dL) within 3 months
- Malignant hypertension
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 |
|---|---|---|
| CalcitriolAlso: Calcio® (Hanmi Pharm Co., Korea)Dosage of 0.25 mcg administered orally once daily for 6 weeks and dose escalated to 0.5 mcg orally once daily up to 6 months | Drug | Calcitriol |
| PlaceboDosage of 0.25 mcg administered orally once daily for 6 weeks and dose escalated to 0.5 mcg orally once daily up to 6 months | Drug | Placebo |
Primary outcome
Changes in proteinuria
Time frame: 6, 12 months after administration
Comparison of proteinuria amount checked by random urine protein/creatinine ratio
2 secondary outcomes
Changes in renal function
Time frame: 3, 6, 9 and 12 months
Changes in urinary renal damage markers
Time frame: 6, 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2012.
Related trials for Proteinuria
Enrolling by invitationObservational study
An Observational Post-Authorization Safety and Effectiveness Study of Ravulizumab in Adult Patients Aged 18 and Older Diagnosed With Paroxysmal Nocturnal Hemoglobinuria Using Multicenter Electronic Medical Records in South Korea
Hemoglobinuria, Paroxysmal
Not yet recruitingObservational study
Obesity-Related Indices and Albuminuria in Type 2 Diabetes
Obesity and Diabetes Mellitus, Type 2, Albuminuria
Active, not recruitingObservational study
Family Investigation of Nephropathy and Diabetes (F.I.N.D.)
Diabetic Nephropathy, Diabetes Mellitus
RecruitingPhase 3
Study of Efficacy and Safety of Iptacopan in Patients With C3 Glomerulopathy.
C3G
RecruitingObservational study
Hypertension in Children and Young People at Risk of Autosomal Dominant Polycystic Kidney Disease
Autosomal Dominant Polycystic Kidney Disease (ADPKD
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.
Jung Mi Oh, Pharm.D. study chair
Seoul National Univerisy College of Pharmacy
Yon Su Kim, M.D., Ph.D. principal investigator
Seoul National University Hospital
3 sites 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 in people with Proteinuria, run by Seoul National University Hospital at 3 sites 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 7 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 10 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nayoung Han, M.S. (+82-2-2072-0335, hans1217@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in proteinuria (time frame: 6, 12 months after administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Apr 2012.