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

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
IgA Nephropathy	Drug: Tacrolimus; Drug: Placebo	Phase 2

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	40 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
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 Start Date :	November 2010
Actual Primary Completion Date :	June 2011
Actual Study Completion Date :	June 2011

Arms and Interventions

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Arm	Intervention/treatment
Experimental: Tacrolimus group	Drug: Tacrolimus; oral; Other Names: Prograf; FK506
Placebo Comparator: Placebo	Drug: Placebo; oral

Outcome Measures

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Primary Outcome Measures :

1. Percent change from baseline UACR to mean value of UACR measured on week 12 and week 16 (UACR: Urine Albumin Creatinine Ratio) [ Time Frame: Week 0, week 12 and week 16 ]

Secondary Outcome Measures :

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

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 70 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Locations

Korea, Republic of
Seoul, Korea, Republic of

Sponsors and Collaborators

Astellas Pharma Inc

Astellas Pharma Korea, Inc.

Investigators

Study Chair:	Use Central Contact	Astellas Pharma Inc

More Information

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Additional Information:

Link to Results on JAPIC - enter 140545 in the JapicCTI-RNo. field 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT01224028 History of Changes
Other Study ID Numbers:	PRGNS-10-01-KOR
First Posted:	October 19, 2010
Last Update Posted:	August 21, 2014
Last Verified:	August 2014

Keywords provided by Astellas Pharma Inc:

Tacrolimus; Prograf; Calcinurin inhibitor	Albuminurea; Proteinurea; FK506

Additional relevant MeSH terms:

Kidney Diseases; Glomerulonephritis, IGA; Urologic Diseases; Glomerulonephritis; Nephritis; Autoimmune Diseases; Immune System Diseases	Tacrolimus; Calcineurin Inhibitors; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action