Clinical trial NCT01224028: A Study to Evaluate the Efficacy and Safety of Tacrolimus in Korean Nephropathy Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: IgA Nephropathy
Keywords: Tacrolimus
Prograf
Calcinurin inhibitor
Albuminurea
Proteinurea
FK506
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
Collaborators: name: Astellas Pharma Korea, Inc.
First posted: 2010-10-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percent change from baseline UACR to mean value of UACR measured on week 12 and week 16 (UACR: Urine Albumin Creatinine Ratio)
timeFrame: Week 0, week 12 and week 16
Secondary outcomes:
measure: Proportion of subjects achieving more than 30% reduction of UACR level from baseline
timeFrame: Week 0 and week 16
measure: Proportion of subjects achieving more than 50% reduction of UACR level from baseline
timeFrame: Week 0 and week 16
measure: Proportion of subjects achieving more than 0.2 reduction of UACR level
timeFrame: Week 0 and week 16
measure: Composite event rate achieving less than 0.2 or 50% reduction of UACR level
timeFrame: Week 0 and week 16
measure: Changes of UACR measured between before the study and each visit
timeFrame: Week 0, week 4, week 8, week 12 and week 16
measure: Incidence of adverse events according to subject's self-assessment, vital signs, investigator's assessment and labo-tests
timeFrame: Through week 16
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
Study officials:
affiliation: Astellas Pharma Inc
name: Use Central Contact
role: STUDY_CHAIR
References:
citation: 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.