IgA NephropathyNCT01237028
Additive Renoprotective Effects of Oral Calcitriol in IgA Nephropathy Patients Taking Renin-Angiotensin System Blockers
A study testing Calcitriol in people with IgA Nephropathy, run by Yonsei University at 7 sites in South Korea.
Trial summary
This study will help to show the efficacy of vitamin D and address the optimal strategy to minimize renal injury in IgAN patients. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- IgA Nephropathy
- What is being tested?
- Calcitriol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 7 sitesSouth Korea
- Study dates
- Mar 2011to Aug 2016
- Phase
- Interventional
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Biopsy-proven Ig AN patients aged 20-70 years
- Patients with residual proteinuria > 500 mg/g creatinine despite renin-angiotensin system blockade and adequate blood pressure control for more than 3 months
- Patients who give informed consent, and 4) estimated GFR >= 30 ml/min/1.73 m2.
Who cannot join
- patients < 20 years or > 70 years
- hypersensitivity to vitamin D analogs
- patients who need urgent dialysis
- hypercalcemia within 3 months (uncorrected serum calcium level > 10.2 mg/dL)
- clinical features of rapidly progressive glomerulonephritis
- life expectancy less than 24 months
Show all 10Show fewer
- uncontrolled hypertension
- decompensated liver or lung disease
- symptomatic heart failure (NYHA class II-IV or LVEF < 40%)
- estimated GFR < 30 ml/min/1.73 m2.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
South Korea7 sites
National Health Insurance Corporation Ilsan Hospital
Goyang, 41-0719
Kwandong University Myongji Hospital
Goyang, 412-270
Wongkwang University Sanbon Medical Center
Gunpo, 435-040
CHA University Bundang Medical Center
Seongnam, 435-040
Seoul National University Hospital
Seoul, 110-752
Severance Hospital
Seoul, 120-752
Ewha Womans University Medical Center
Seoul, 158-710
About this study
This study will help to show the efficacy of vitamin D and address the optimal strategy to minimize renal injury in IgAN patients.
- Conditions
- IgA Nephropathy
- Being tested
- Calcitriol
- Medical subject headings
- Glomerulonephritis, IGA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CalcitriolDrug
Calcitriol(1,25-dihydroxycholecalciferol, vitamin D3 analog)0.25 μg per day
| Study group | Role | What they receive |
|---|---|---|
| oral calcitriol | Experimental | Calcio® Receives: Drug: Calcitriol |
| placebo | No intervention | Not described |
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 and 24hour urine protein
Measured: random urine protein/creatinine ratio every 2month and 24hour urine protein every 6month
Secondary outcomes (5)
changes in serum creatinine
comparison of renal function checked by serum creatinine and calculated renal function by MDRD equation
Measured: serum creatinine every 2month
changes in systolic blood pressure and diastolic pressure
check systolic and diastolic blood pressure
Measured: check blood pressure at very first visit and every 2-month
changes in urinary biomarkers (angiotensinogen, angiotensin II, TGF-beat, IL-6, MCP-1, TNF-alpha)
urine marker check every 6month
Measured: every 6month
changes in serum 25(OH)2D3, 1,25(OH)2D3, parathyroid hormone
serum marker check every 6month
Measured: every 6month
changes in serum inflammatory markers (hsCRP, IL-6)
serum marker check every 6month
Measured: every 6month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2010 (estimated)
- Study startMar 2011
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IgA NephropathyStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tae-Hyun Yoo, MD, Ph.D, Principal investigator, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01237028
- Sponsor's protocol ID
- 4-2010-0439
- Status last verified
- Sep 2016
- First submitted
- 8 Nov 2010
- Last updated
- 7 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Additive Renoprotective Effects of Oral Calcitriol in IgA Nephropathy Patients Taking Renin-Angiotensin System Blockers
- ClinicalTrials.gov ID
- NCT01237028
- Acronym / sponsor ID
- 4-2010-0439
- Conditions
- IgA Nephropathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 9 Nov 2010 (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.
This study will help to show the efficacy of vitamin D and address the optimal strategy to minimize renal injury in IgAN patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| oral calcitriol | Experimental | Drug: CalcitriolCalcio® |
| placebo | No intervention | – |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Biopsy-proven Ig AN patients aged 20-70 years
- Patients with residual proteinuria > 500 mg/g creatinine despite renin-angiotensin system blockade and adequate blood pressure control for more than 3 months
- Patients who give informed consent, and 4) estimated GFR >= 30 ml/min/1.73 m2.
Key exclusion criteria (10 listed)
- patients < 20 years or > 70 years
- hypersensitivity to vitamin D analogs
- patients who need urgent dialysis
- hypercalcemia within 3 months (uncorrected serum calcium level > 10.2 mg/dL)
- clinical features of rapidly progressive glomerulonephritis
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 |
|---|---|---|
| CalcitriolCalcitriol(1,25-dihydroxycholecalciferol, vitamin D3 analog)0.25 μg per day | Drug | oral calcitriol |
Primary outcome
changes in proteinuria
Time frame: random urine protein/creatinine ratio every 2month and 24hour urine protein every 6month
comparison of proteinuria amount checked by random urine protein/creatinine and 24hour urine protein
5 secondary outcomes
changes in serum creatinine
Time frame: serum creatinine every 2month
changes in systolic blood pressure and diastolic pressure
Time frame: check blood pressure at very first visit and every 2-month
changes in urinary biomarkers (angiotensinogen, angiotensin II, TGF-beat, IL-6, MCP-1, TNF-alpha)
Time frame: every 6month
changes in serum 25(OH)2D3, 1,25(OH)2D3, parathyroid hormone
Time frame: every 6month
changes in serum inflammatory markers (hsCRP, IL-6)
Time frame: every 6month
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 7 Sep 2016.
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Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of KP104 to Treat Glomerulonephritis
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IgA Nephropathy (IgAN)
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.
Tae-Hyun Yoo, MD, Ph.D principal investigator
Severance Hospital
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Calcitriol in people with IgA Nephropathy, run by Yonsei University at 7 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 3 inclusion and 10 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 7 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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.
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?
changes in proteinuria (time frame: random urine protein/creatinine ratio every 2month and 24hour urine protein every 6month). 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 7 Sep 2016.