NCT01224028

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Nov 2010

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 18, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 19, 2010

Completed
13 days until next milestone

Study Start

First participant enrolled

November 1, 2010

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

August 21, 2014

Status Verified

August 1, 2014

Enrollment Period

7 months

First QC Date

October 18, 2010

Last Update Submit

August 20, 2014

Conditions

IgA Nephropathy

Keywords

TacrolimusPrografCalcinurin inhibitorAlbuminureaProteinureaFK506

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Proportion of subjects achieving more than 30% reduction of UACR level from baseline

    Week 0 and week 16

  • 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

  • Composite event rate achieving less than 0.2 or 50% reduction of UACR level

    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

  • +1 more secondary outcomes

Study Arms (2)

Tacrolimus group

EXPERIMENTAL
Drug: Tacrolimus

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

TacrolimusDRUG

oral

Also known as: Prograf, FK506
Tacrolimus group
PlaceboDRUG

oral

Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Seoul, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 23977072DERIVED

MeSH Terms

Conditions

Glomerulonephritis, IGA

Interventions

Tacrolimus

Condition Hierarchy (Ancestors)

GlomerulonephritisNephritisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic Chemicals

Study Officials

  • Use Central Contact

    Astellas Pharma Inc

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 18, 2010

First Posted

October 19, 2010

Study Start

November 1, 2010

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

August 21, 2014

Record last verified: 2014-08

Locations

KR(1)