A Study to Evaluate the Efficacy and Safety of Tacrolimus in Korean Nephropathy Patients - Full Text View

Purpose

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	Intervention	Phase
IgA Nephropathy	Drug: Tacrolimus Drug: Placebo	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

MedlinePlus related topics: Kidney Diseases

Drug Information available for: Tacrolimus

Genetic and Rare Diseases Information Center resources: Berger Disease Glomerulonephritis

U.S. FDA Resources

Further study details as provided by Astellas Pharma Inc:

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) [ Time Frame: Week 0, week 12 and week 16 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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


Enrollment:	40
Study Start Date:	November 2010
Study Completion Date:	June 2011
Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Tacrolimus group	Drug: Tacrolimus oral Other Names: Prograf FK506
Placebo Comparator: Placebo	Drug: Placebo oral

Eligibility


Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01224028

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

Additional Information:

Link to Results on JAPIC - enter 140545 in the JapicCTI-RNo. field This link exits the ClinicalTrials.gov site

No publications provided


Responsible Party:	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT01224028 History of Changes
Other Study ID Numbers:	PRGNS-10-01-KOR
Study First Received:	October 18, 2010
Last Updated:	August 20, 2014
Health Authority:	Korea: Food and Drug Administration

Keywords provided by Astellas Pharma Inc:


Tacrolimus Prograf Calcinurin inhibitor	Albuminurea Proteinurea FK506

Additional relevant MeSH terms:


Glomerulonephritis, IGA Kidney Diseases Autoimmune Diseases Glomerulonephritis Immune System Diseases Nephritis	Urologic Diseases Tacrolimus Immunologic Factors Immunosuppressive Agents Pharmacologic Actions Physiological Effects of Drugs

ClinicalTrials.gov processed this record on March 03, 2015