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A Study to Evaluate the Efficacy and Safety of Tacrolimus in Korean Nephropathy Patients
This study has been completed.
Sponsor:
Astellas Pharma Inc
Collaborator:
Astellas Pharma Korea, Inc.
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01224028
First received: October 18, 2010
Last updated: August 20, 2014
Last verified: August 2014
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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 Intervention Model: Parallel Assignment Masking: Double Blind (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 |
Resource links provided by NLM:
MedlinePlus related topics:
Kidney Diseases
Drug Information available for:
Tacrolimus
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 ]
Secondary Outcome Measures:
- Proportion of subjects achieving more than 30% reduction of UACR level from baseline [ Time Frame: Week 0 and week 16 ]
- Proportion of subjects achieving more than 50% reduction of UACR level from baseline [ Time Frame: Week 0 and week 16 ]
- Proportion of subjects achieving more than 0.2 reduction of UACR level [ Time Frame: Week 0 and week 16 ]
- Composite event rate achieving less than 0.2 or 50% reduction of UACR level [ Time Frame: Week 0 and week 16 ]
- Changes of UACR measured between before the study and each visit [ Time Frame: Week 0, week 4, week 8, week 12 and week 16 ]
- Incidence of adverse events according to subject's self-assessment, vital signs, investigator's assessment and labo-tests [ Time Frame: Through week 16 ]
| 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:
|
| Placebo Comparator: Placebo |
Drug: Placebo
oral
|
Eligibility| 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
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
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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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 |
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 |
ClinicalTrials.gov processed this record on June 23, 2017