A Study to Evaluate the Efficacy and Safety of Tacrolimus With Steroid in Korean Lupus Nephritis Patients
NCT ID: NCT01316133
Last Updated: 2024-10-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE4
37 participants
INTERVENTIONAL
2011-04-19
2016-04-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Tacrolimus group
Oral
tacrolimus
oral
Interventions
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tacrolimus
oral
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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)
Exclusion Criteria
* 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
20 Years
ALL
No
Sponsors
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Astellas Pharma Korea, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Use Central Contact
Role: STUDY_CHAIR
Astellas Pharma Inc
Locations
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Busan, , South Korea
Daegu, , South Korea
Daejeon, , South Korea
Gwangju, , South Korea
Incheon, , South Korea
Jeonju, , South Korea
Seoul, , South Korea
Countries
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Related Links
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Link to results on the Astellas Clinical Study Results website
Other Identifiers
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PRGLN-10-01-KOR
Identifier Type: -
Identifier Source: org_study_id
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