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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 70 Years (Adult, Senior)
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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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