IgA Nephropathy
Conditions
Keywords
Tacrolimus, Prograf, Calcinurin inhibitor, Albuminurea, Proteinurea, FK506
Brief summary
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.
Interventions
DRUGTacrolimus
oral
DRUGPlacebo
oral
Sponsors
Astellas Pharma Korea, Inc.
Astellas Pharma Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| 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 |
| Proportion of subjects achieving more than 30% reduction of UACR level from baseline | 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 |
| Composite event rate achieving less than 0.2 or 50% reduction of UACR level | Week 0 and week 16 |
Countries
South Korea
Outcome results
None listed