A Study to Evaluate the Efficacy and Safety of Tacrolimus in Korean Nephropathy Patients

Study Overview
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Brief Summary
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This study is to evaluate efficacy and safety of tacrolimus in the patients with non-nephrotic albuminuric, normotensive IgA nephropathy after 16 week treatment with tacrolimus (Prograf) or placebo.

Official Title
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Double-blind, Randomized Placebo-controlled Clinical Trial for the Efficacy and Safety of a Calcineurin Inhibitor, Tacrolimus(Prograf Cap®) in Patients With Non-nephrotic Albuminuric, Normotensive IgA Nephropathy

Conditions
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IgA Nephropathy

Intervention / Treatment
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* Drug: Tacrolimus
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with IgA nephropathy confirmed by renal biopsy 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: Use of immunosuppressants for more than two weeks within last one month 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tacrolimus group<br> | Drug: Tacrolimus<br>* oral<br>* Other names: FK506;|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* oral<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change from baseline UACR to mean value of UACR measured on week 12 and week 16 (UACR: Urine Albumin Creatinine Ratio) |  | Week 0, week 12 and week 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects achieving more than 30% reduction of UACR level from baseline |  | Week 0 and week 16 | 
| Proportion of subjects achieving more than 50% reduction of UACR level from baseline |  | Week 0 and week 16 | 
| Proportion of subjects achieving more than 0.2 reduction of UACR level |  | Week 0 and week 16 | 
| Composite event rate achieving less than 0.2 or 50% reduction of UACR level |  | Week 0 and week 16 | 
| Changes of UACR measured between before the study and each visit |  | Week 0, week 4, week 8, week 12 and week 16 | 
| Incidence of adverse events according to subject's self-assessment, vital signs, investigator's assessment and labo-tests |  | Through week 16 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tacrolimus, Prograf, Calcinurin inhibitor, Albuminurea, Proteinurea, FK506