Lupus NephritisPhase 4APPLENCT01316133
A Study to Evaluate the Efficacy and Safety of Tacrolimus With Steroid in Korean Lupus Nephritis Patients
A Phase 4 study testing tacrolimus in people with Lupus Nephritis, run by Astellas Pharma Korea, Inc. at 7 sites in South Korea.
Trial summary
This study is to evaluate efficacy and safety of tacrolimus with steroid by observing remission rate at 24 weeks in lupus nephritis patients who are non-responders to steroid monotherapy. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Lupus Nephritis
- What is being tested?
- tacrolimus
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 7 sitesSouth Korea
- Study dates
- 19 Apr 2011to 8 Apr 2016
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who satisfy more than 4 criteria for diagnosis of systemic lupus erythematosus (ARA criteria, 1982)
- Patients who fall under WHO class III-IV lupus nephritis on renal biopsy
- Patients with refractory lupus nephritis
- Proteinuria ≥ 0.5 g/day
- Patients who took steroid ≥ 20 mg/day over one month prior to the study
- Patients who failed a first-line therapy (non-responders to steroid monotherapy)
Who cannot join
- Patients who are allergic or resistant to macrolide antibiotics or tacrolimus
- Patients who received tacrolimus in the past (excluding drugs for external use)
- Patients who used other immunosuppressants within 4 weeks before initiation of the study
- Patients who have been receiving systematic chemotherapy since before enrollment (local chemotherapy is allowed.)
- Patients with malignant tumor which developed within the recent 5 years or history of malignant tumor
- Patients who have severe diarrhea, vomiting, active peptic ulcer or gastrointestinal disorders which may influence absorption of tacrolimus
- Patients with S-Cr ≥ 200 µ㏖/L or ≥ 2.3 mg/dL
- Patients with liver function levels of more than twice the upper limit of normal or acute active hepatitis
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
South Korea7 sites
Study site
Busan
Study site
Daegu
Study site
Daejeon
Study site
Gwangju
Study site
Incheon
Study site
Jeonju
Study site
Seoul
About this study
Official title: A Multicenter, Non-comparative, Open-labeled, Prospective Study to Evaluate the Efficacy and Safety of Tacrolimus (Prograf®) With Steroid in Korean Lupus Nephritis Patients Who Are Non-responders to Steroid Monotherapy
This study is to evaluate efficacy and safety of tacrolimus with steroid by observing remission rate at 24 weeks in lupus nephritis patients who are non-responders to steroid monotherapy.
- Conditions
- Lupus Nephritis
- Being tested
- tacrolimus
- Keywords
- Tacrolimus, Prograf, FK506, Proteinuria, Calcineurin inhibitor
- Medical subject headings
- Lupus Nephritis, Proteinuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tacrolimusDrug
Also called Prograf, FK506
oral
| Study group | Role | What they receive |
|---|---|---|
| Tacrolimus group | Experimental | Oral Receives: Drug: tacrolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Remission rate
Percentage of the patients who shows complete remission or partial remission
Measured: 24 weeks
Secondary outcomes (4)
Complete remission rate
Measured: 24 weeks
Change from baseline in urine protein to creatinine ratio
Measured: Baseline, 4 weeks, 12 weeks and 24 weeks
Change from baseline in serum creatinine
Measured: Baseline, 4 weeks, 12 weeks and 24 weeks
Safety assessed by the incidence of adverse events, abnormal findings of laboratory tests and vital signs
Measured: for 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2011 (estimated)
- Study start19 Apr 2011
- Primary completion8 Apr 2016
- Study completion8 Apr 2016
Why it stopped: Study terminated due to poor patient recruitment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lupus NephritisStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Korea, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Use Central Contact, Study chair, Astellas Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01316133
- Sponsor's protocol ID
- PRGLN-10-01-KOR
- Acronym
- APPLE
- Status last verified
- Oct 2024
- First submitted
- 14 Mar 2011
- Last updated
- 31 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Non-comparative, Open-labeled, Prospective Study to Evaluate the Efficacy and Safety of Tacrolimus (Prograf®) With Steroid in Korean Lupus Nephritis Patients Who Are Non-responders to Steroid Monotherapy
- ClinicalTrials.gov ID
- NCT01316133
- Acronym / sponsor ID
- APPLE / PRGLN-10-01-KOR
- Conditions
- Lupus Nephritis
- Keywords
- Tacrolimus, Prograf, FK506, Proteinuria, Calcineurin inhibitor
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study terminated due to poor patient recruitment.
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Astellas Pharma Korea, Inc.Industry (pharma, biotech, devices)
- Study start
- 19 Apr 2011 (actual)
- Primary completion
- 8 Apr 2016 (actual)
- Study completion
- 8 Apr 2016 (actual)
- First posted
- 16 Mar 2011 (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 is to evaluate efficacy and safety of tacrolimus with steroid by observing remission rate at 24 weeks in lupus nephritis patients who are non-responders to steroid monotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tacrolimus group | Experimental | Drug: tacrolimusOral |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients who satisfy more than 4 criteria for diagnosis of systemic lupus erythematosus (ARA criteria, 1982)
- Patients who fall under WHO class III-IV lupus nephritis on renal biopsy
- Patients with refractory lupus nephritis
- Proteinuria ≥ 0.5 g/day
- Patients who took steroid ≥ 20 mg/day over one month prior to the study
Key exclusion criteria (8 listed)
- Patients who are allergic or resistant to macrolide antibiotics or tacrolimus
- Patients who received tacrolimus in the past (excluding drugs for external use)
- Patients who used other immunosuppressants within 4 weeks before initiation of the study
- Patients who have been receiving systematic chemotherapy since before enrollment (local chemotherapy is allowed.)
- Patients with malignant tumor which developed within the recent 5 years or history of malignant tumor
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: Prograf, FK506oral | Drug | Tacrolimus group |
Primary outcome
Remission rate
Time frame: 24 weeks
Percentage of the patients who shows complete remission or partial remission
4 secondary outcomes
Complete remission rate
Time frame: 24 weeks
Change from baseline in urine protein to creatinine ratio
Time frame: Baseline, 4 weeks, 12 weeks and 24 weeks
Change from baseline in serum creatinine
Time frame: Baseline, 4 weeks, 12 weeks and 24 weeks
Safety assessed by the incidence of adverse events, abnormal findings of laboratory tests and vital signs
Time frame: for 24 weeks
Results and safety
The study was stopped early (reason given: Study terminated due to poor patient recruitment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2024.
- Individual participant dataSharing planned: No. Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
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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.
Use Central Contact study chair
Astellas Pharma Inc
7 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 tacrolimus in people with Lupus Nephritis, run by Astellas Pharma Korea, Inc. 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 6 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: stopped early, as of the sponsor's last update on 31 Oct 2024. 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.
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 was stopped early (reason given: Study terminated due to poor patient recruitment.). Results are not available in the source record.
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 rate (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 31 Oct 2024.