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

IgA Nephropathy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01224028
• Other study ID #: PRGNS-10-01-KOR
• Status: Completed
• Phase: Phase 2
• First received: October 18, 2010
• Last updated: August 20, 2014
• Start date: November 2010
• Est. completion date: June 2011

Study information

• Verified date: August 2014
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glomerulonephritis, IGA
• IgA Nephropathy
• Kidney Diseases

Intervention

Drug:
• Tacrolimus
oral
• Placebo
oral

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Astellas Pharma Inc	Astellas Pharma Korea, Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Proportion of subjects achieving more than 30% reduction of UACR level from baseline		Week 0 and week 16	No
Secondary	Proportion of subjects achieving more than 50% reduction of UACR level from baseline		Week 0 and week 16	No
Secondary	Proportion of subjects achieving more than 0.2 reduction of UACR level		Week 0 and week 16	No
Secondary	Composite event rate achieving less than 0.2 or 50% reduction of UACR level		Week 0 and week 16	No
Secondary	Changes of UACR measured between before the study and each visit		Week 0, week 4, week 8, week 12 and week 16	No
Secondary	Incidence of adverse events according to subject's self-assessment, vital signs, investigator's assessment and labo-tests		Through week 16	No

External Links

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