Minimal Change DiseasePhase 2/3MCNSNCT01084980
Therapeutic Effect of Tacrolimus in Combination With Low Dose Corticosteroid in Adult Patient With Minimal Change Nephritic Syndrome
A Phase 2/3 study testing Tacrolimus in people with Minimal Change Disease, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The hypothesis of this study is that tacrolimus reduces the proteinuria in adult patient with minimal change nephritic syndrome. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Minimal Change Disease
- What is being tested?
- Tacrolimus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2010to Jul 2011
- Phase
- Phase 2/3
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- from 18yrs to 80 yrs , man and women
- Minimal change disease is diagnosed by kidney biopsy
- On screening, the patient shows that the level of urine protein/creatinine ratio is over 3.0
- On screening, the patient shows that the serum albumin is below 3.0g/dL
- the patient sign on the concent form
Who cannot join
- the patient have experience to take tacrolimus or cyclosporin for 1 month
- If it is the relapse of the nephrotic syndrome, before relapse, the maintenance dose of steroid is over 0.3 mg/kg/day
- steroid dependent or steroid resistant or frequent relapse case
- uncontrolled hypertension
- pregnancy or anticipate pregnancy with 6 month
- hypersensitivity to tacrolimus or macrolide
- acute hepatitis or the level of AST or ALT is over 2 times of normal range or the level of bilirubin is over 2.0 mg/dL
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study for Comparative Clinical Trial on the Therapeutic Effect of Tacrolimus (Prograf Cap®) in Combination With Low Dose Corticosteroid in Adult Patient With Minimal Change Nephritic Syndrome
The hypothesis of this study is that tacrolimus reduces the proteinuria in adult patient with minimal change nephritic syndrome.
Read the detailed description
A pilot study for comparative clinical trial on the therapeutic effect of tacrolimus (Prograf cap®) in adult patient with minimal change nephritic syndrome.
- Conditions
- Minimal Change Disease
- Being tested
- Tacrolimus
- Keywords
- minimal change disease, tacrolimus, corticosteroid
- Medical subject headings
- Nephrosis, Lipoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TacrolimusDrug
Also called Prograf
tacrolimus 0.05mg/kg bid for 12 weeks corticosteroid 0.3 - 0.5mg/kg qd
| Study group | Role | What they receive |
|---|---|---|
| Tacrolimus | Experimental | Not described Receives: Drug: Tacrolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
remission of proteinuria
Measured: 12 weeks
Secondary outcomes (1)
time to remission, relapse rate, response failure rate
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2010 (estimated)
- Study startJun 2010
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Minimal Change DiseaseStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01084980
- Sponsor's protocol ID
- MCNS001
- Acronym
- MCNS
- Status last verified
- Aug 2011
- First submitted
- 10 Mar 2010
- Last updated
- 16 Aug 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study for Comparative Clinical Trial on the Therapeutic Effect of Tacrolimus (Prograf Cap®) in Combination With Low Dose Corticosteroid in Adult Patient With Minimal Change Nephritic Syndrome
- ClinicalTrials.gov ID
- NCT01084980
- Acronym / sponsor ID
- MCNS / MCNS001
- Conditions
- Minimal Change Disease
- Keywords
- minimal change disease, tacrolimus, corticosteroid
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 11 Mar 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.
The hypothesis of this study is that tacrolimus reduces the proteinuria in adult patient with minimal change nephritic syndrome.
Detailed description
A pilot study for comparative clinical trial on the therapeutic effect of tacrolimus (Prograf cap®) in adult patient with minimal change nephritic syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tacrolimus | Experimental | Drug: Tacrolimus |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- from 18yrs to 80 yrs , man and women
- Minimal change disease is diagnosed by kidney biopsy
- On screening, the patient shows that the level of urine protein/creatinine ratio is over 3.0
- On screening, the patient shows that the serum albumin is below 3.0g/dL
- the patient sign on the concent form
Key exclusion criteria (7 listed)
- the patient have experience to take tacrolimus or cyclosporin for 1 month
- If it is the relapse of the nephrotic syndrome, before relapse, the maintenance dose of steroid is over 0.3 mg/kg/day
- steroid dependent or steroid resistant or frequent relapse case
- uncontrolled hypertension
- pregnancy or anticipate pregnancy with 6 month
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 |
|---|---|---|
| TacrolimusAlso: Prograftacrolimus 0.05mg/kg bid for 12 weeks corticosteroid 0.3 - 0.5mg/kg qd | Drug | Tacrolimus |
Primary outcome
remission of proteinuria
Time frame: 12 weeks
1 secondary outcome
time to remission, relapse rate, response failure rate
Time frame: 12 weeks
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 16 Aug 2011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Tacrolimus in people with Minimal Change Disease, 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 5 inclusion and 7 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 16 Aug 2011. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
remission of proteinuria (time frame: 12 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 16 Aug 2011.