A Study to Evaluate the Efficacy and Safety of Tacrolimus in Korean Nephropathy Patients
NCT ID: NCT01224028
Last Updated: 2014-08-21
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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COMPLETED
PHASE2
40 participants
INTERVENTIONAL
2010-11-30
2011-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Tacrolimus group
Tacrolimus
oral
Placebo
Placebo
oral
Interventions
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Tacrolimus
oral
Placebo
oral
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Serum creatinine measurement ≤1.5mg/ml or MDRD estimated GFR ≥ 45ml/min/1.73m2 (MDRD: Modification of Diet in Renal Disorder)
* UACR level between 0.3 and 3.0
* Blood pressure measurements \< 130/80mmHg
Exclusion Criteria
* Concomitant use of ACE inhibitor, ARB, steroids or immunosuppressant, NDHP-CCB, diuretics, omega-3 fatty acids and its analogue \& additional dietary to treat igA nephropathy (ACE: Angiotensin Converting Enzyme, ARB: Angiotensin Receptor Blocker, NDHP-CCB: Non-dihydropyridine-type Calcium Channel Blocker
* Pregnant or breast-feeding patients. Patients who plan to bear children or breast-feed during the study and within 6 month after completion of study
* Hypersensitivity to the investigational drug or macrolide agents
* Use of potassium-sparing diuretics
* Persistence of liver function abnormality more than 1 month or presence of acute active hepatitis
* Other investigational drug within last 30 days
18 Years
70 Years
ALL
No
Sponsors
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Astellas Pharma Korea, Inc.
INDUSTRY
Astellas Pharma 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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Seoul, , South Korea
Countries
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References
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Kim YC, Chin HJ, Koo HS, Kim S. Tacrolimus decreases albuminuria in patients with IgA nephropathy and normal blood pressure: a double-blind randomized controlled trial of efficacy of tacrolimus on IgA nephropathy. PLoS One. 2013 Aug 19;8(8):e71545. doi: 10.1371/journal.pone.0071545. eCollection 2013.
Other Identifiers
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PRGNS-10-01-KOR
Identifier Type: -
Identifier Source: org_study_id
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