Chronic Kidney DiseasePhase 4NCT01820832
Oral Calcitriol for Reduction of Mild Proteinuria in Patients With CKD
A Phase 4 study testing Calcitriol in people with Chronic Kidney Disease and Proteinuria, run by Huashan Hospital at 1 site in China.
Trial summary
The safety and efficacy of Caltriol on mild proteinuria (<1.0g/d) reduction in CKD patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Kidney Disease, Proteinuria
- What is being tested?
- Calcitriol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Mar 2013to Jun 2015
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged 18-75 years
- clinical diagnosed and/or biopsy-confirmed primary glomerulonephritis
- proteinuria 0.15-1.0 g/d in 2 consecutive samples within 4 weeks despite ACE inhibitor (ACEI) or angiotensin receptor blocker (ARB) treatment for at least 1 year or ACEI/ARB withdrawal because of of drug intolerances (low blood pressure, cough, hyperkalemia) for at least 1 month
- estimated glomerular filtration rate (eGFR)>60ml/min/1/73m2
- corticosteroid and immunosuppressive agents withdrawal for at least 6 months
- normal blood pressure
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- serum intact parathyroid hormone (iPTH) level >20pg/mL
- corrected serum calcium level < or = 2.55 mmol/L
- serum phosphorus level < or = 1.68 mmol/L
- 24 hours urinary calcium excretion level < or = 7.5 mmol
- not receive treatment of vitamin D or its analogue within 6 months
- willigness to give written consent and comply with the study protocol
Who cannot join
- history of sensitivity or allergy to calcitriol or other vitamin D analogs
- pregnancy, lactating women
- history of severe coexisting disease such as, but not limited to, chronic liver disease, myocardial infarction, cerebrovascular accident, malignant hypertension
- history of malignancy
- history of extraskeletal calcification, hyperuricemia, gout, kidney stone, gall stone, bone diseases
- patients receiving drugs contains of calcium
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- patients receiving cimetidine, trimethoprim, or other drugs which can increase tubular creatinine reabsorption
- participation in any other trials within 1 month
- history of non-compliance
Trial locations and contacts
1 site in 1 country.
China1 site
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200040
Li You, M.D. PhD, 86-21-52888133, youlizzy@gmail.com
About this study
Official title: Phase 4 Study of Oral Calcitriol for Reduction of Mild Proteinuria in Patients With CKD
The safety and efficacy of Caltriol on mild proteinuria (<1.0g/d) reduction in CKD patients.
Read the detailed description
Proteinuria is not only a capital sign of kidney disease, but also a marker of chronic kidney disease (CKD) progression. Emerging evidence in patients with CKD show that vitamin D and its analogs can reduce proteinuria or albuminuria in the presence of angiotensin-converting enzyme inhibithion. While some of the studies reported that vitamin D receptor activation has been associated with increased serum creatinine and reduced estimated glomerular filtration rates. Therefore, the investigators plan to conduct a randomized clinical study to evaluate the efficacy and safety of Calcitriol in the treatment of mild proteinuria (<1.0g/d) CKD patients,which has no specific treatment at present.
- Conditions
- Chronic Kidney Disease, Proteinuria
- Being tested
- Calcitriol
- Keywords
- mild proteinuria, calcitriol, renal function, blood pressure
- Medical subject headings
- Renal Insufficiency, Chronic, Proteinuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CalcitriolDrug
Also called 1, 25 - dihydroxy Cholecalciferol
Calcitriol 0.5 ug/BIW for 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Calcitriol | Experimental | General treatments (such as blood pressure control, lipid lowering, and so on) plus Calcitriol 0.5 ug/BIW for 24 weeks. Receives: Drug: Calcitriol |
| Control | No intervention | General treatments. |
What is being measured
The primary outcome is the main question the study is designed to answer.
the percentage change of proteinuia
Measured: 24 weeks
Secondary outcomes (1)
the proportion of patients achieving at least a 15% decrease in proteinuria
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionDec 2014 (estimated)
- Study completionJun 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Huashan 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jing Chen, Huashan Hospital
- Investigators
- Jing Chen, M.D. PhD, Principal investigator, Division of Nephrology, Huashan Hospital, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01820832
- Sponsor's protocol ID
- Calcitriol-MP-1
- Status last verified
- Mar 2013
- First submitted
- 19 Mar 2013
- Last updated
- 29 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 4 Study of Oral Calcitriol for Reduction of Mild Proteinuria in Patients With CKD
- ClinicalTrials.gov ID
- NCT01820832
- Acronym / sponsor ID
- Calcitriol-MP-1
- Conditions
- Chronic Kidney Disease, Proteinuria
- Keywords
- mild proteinuria, calcitriol, renal function, blood pressure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 29 Mar 2013 (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.
The safety and efficacy of Caltriol on mild proteinuria (<1.0g/d) reduction in CKD patients.
Detailed description
Proteinuria is not only a capital sign of kidney disease, but also a marker of chronic kidney disease (CKD) progression. Emerging evidence in patients with CKD show that vitamin D and its analogs can reduce proteinuria or albuminuria in the presence of angiotensin-converting enzyme inhibithion. While some of the studies reported that vitamin D receptor activation has been associated with increased serum creatinine and reduced estimated glomerular filtration rates. Therefore, the investigators plan to conduct a randomized clinical study to evaluate the efficacy and safety of Calcitriol in the treatment of mild proteinuria (<1.0g/d) CKD patients,which has no specific treatment at present.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Calcitriol | Experimental | Drug: CalcitriolGeneral treatments (such as blood pressure control, lipid lowering, and so on) plus Calcitriol 0.5 ug/BIW for 24 weeks. |
| Control | No intervention | –General treatments. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- aged 18-75 years
- clinical diagnosed and/or biopsy-confirmed primary glomerulonephritis
- proteinuria 0.15-1.0 g/d in 2 consecutive samples within 4 weeks despite ACE inhibitor (ACEI) or angiotensin receptor blocker (ARB) treatment for at least 1 year or ACEI/ARB withdrawal because of of drug intolerances (low blood pressure, cough, hyperkalemia) for at least 1 month
- estimated glomerular filtration rate (eGFR)>60ml/min/1/73m2
- corticosteroid and immunosuppressive agents withdrawal for at least 6 months
Key exclusion criteria (9 listed)
- history of sensitivity or allergy to calcitriol or other vitamin D analogs
- pregnancy, lactating women
- history of severe coexisting disease such as, but not limited to, chronic liver disease, myocardial infarction, cerebrovascular accident, malignant hypertension
- history of malignancy
- history of extraskeletal calcification, hyperuricemia, gout, kidney stone, gall stone, bone diseases
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: 1, 25 - dihydroxy CholecalciferolCalcitriol 0.5 ug/BIW for 24 weeks. | Drug | Calcitriol |
Primary outcome
the percentage change of proteinuia
Time frame: 24 weeks
1 secondary outcome
the proportion of patients achieving at least a 15% decrease in proteinuria
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2013.
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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.
Jing Chen, M.D. PhD principal investigator
Division of Nephrology, Huashan Hospital, Fudan 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 in people with Chronic Kidney Disease and Proteinuria, run by Huashan Hospital at 1 site in China.
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 12 inclusion and 9 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 29 Mar 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 China. 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 Jing Chen, M.D. PhD (86-21-52889387, chenjing1998@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the percentage change of proteinuia (time frame: 24 weeks). 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 29 Mar 2013.