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

Primary Purpose

IgA Nephropathy

Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Tacrolimus
Placebo
Sponsored by
Astellas Pharma Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for IgA Nephropathy focused on measuring Tacrolimus, Prograf, Calcinurin inhibitor, Albuminurea, Proteinurea, FK506

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Tacrolimus group

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Percent change from baseline UACR to mean value of UACR measured on week 12 and week 16 (UACR: Urine Albumin Creatinine Ratio)

Secondary Outcome Measures

Proportion of subjects achieving more than 30% reduction of UACR level from baseline
Proportion of subjects achieving more than 50% reduction of UACR level from baseline
Proportion of subjects achieving more than 0.2 reduction of UACR level
Composite event rate achieving less than 0.2 or 50% reduction of UACR level
Changes of UACR measured between before the study and each visit
Incidence of adverse events according to subject's self-assessment, vital signs, investigator's assessment and labo-tests

Full Information

First Posted
October 18, 2010
Last Updated
August 20, 2014
Sponsor
Astellas Pharma Inc
Collaborators
Astellas Pharma Korea, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01224028
Brief Title
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

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Inc
Collaborators
Astellas Pharma Korea, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
IgA Nephropathy
Keywords
Tacrolimus, Prograf, Calcinurin inhibitor, Albuminurea, Proteinurea, FK506

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tacrolimus group
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Tacrolimus
Other Intervention Name(s)
Prograf, FK506
Intervention Description
oral
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
oral
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Proportion of subjects achieving more than 30% reduction of UACR level from baseline
Time Frame
Week 0 and week 16
Title
Proportion of subjects achieving more than 50% reduction of UACR level from baseline
Time Frame
Week 0 and week 16
Title
Proportion of subjects achieving more than 0.2 reduction of UACR level
Time Frame
Week 0 and week 16
Title
Composite event rate achieving less than 0.2 or 50% reduction of UACR level
Time Frame
Week 0 and week 16
Title
Changes of UACR measured between before the study and each visit
Time Frame
Week 0, week 4, week 8, week 12 and week 16
Title
Incidence of adverse events according to subject's self-assessment, vital signs, investigator's assessment and labo-tests
Time Frame
Through week 16

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Use Central Contact
Organizational Affiliation
Astellas Pharma Inc
Official's Role
Study Chair
Facility Information:
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
23977072
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.
Results Reference
derived
Links:
URL
http://www.clinicaltrials.jp/user/ctrSearch_e.jsp
Description
Link to Results on JAPIC - enter 140545 in the JapicCTI-RNo. field

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

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