A Study to Evaluate the Efficacy and Safety of Tacrolimus With Steroid in Korean Lupus Nephritis Patients (APPLE)
This study is currently recruiting participants.
Verified October 2011 by Astellas Pharma Inc
Sponsor:
Astellas Pharma Inc
Collaborator:
Astellas Pharma Korea, Inc.
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01316133
First received: March 14, 2011
Last updated: October 10, 2011
Last verified: October 2011
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Purpose
This study is to evaluate efficacy and safety of tacrolimus with steroid by observing remission rate at 24 weeks in lupus nephritis patients who are non-responders to steroid monotherapy.
| Condition | Intervention | Phase |
|---|---|---|
|
Lupus Nephritis |
Drug: tacrolimus |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Multicenter, Non-comparative, Open-labeled, Prospective Study to Evaluate the Efficacy and Safety of Tacrolimus (Prograf®) With Steroid in Korean Lupus Nephritis Patients Who Are Non-responders to Steroid Monotherapy |
Resource links provided by NLM:
Further study details as provided by Astellas Pharma Inc:
Primary Outcome Measures:
- Remission rate [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]Percentage of the patients who shows complete remission or partial remission
Secondary Outcome Measures:
- Complete remission rate [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- Change from baseline in urine protein to creatinine ratio [ Time Frame: Baseline, 4 weeks, 12 weeks and 24 weeks ] [ Designated as safety issue: No ]
- Change from baseline in serum creatinine [ Time Frame: Baseline, 4 weeks, 12 weeks and 24 weeks ] [ Designated as safety issue: No ]
- Safety assessed by the incidence of adverse events, abnormal findings of laboratory tests and vital signs [ Time Frame: for 24 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 56 |
| Study Start Date: | February 2011 |
| Estimated Study Completion Date: | October 2012 |
| Estimated Primary Completion Date: | October 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Tacrolimus group |
Drug: tacrolimus
oral
Other Names:
|
Eligibility| Ages Eligible for Study: | 20 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients who satisfy more than 4 criteria for diagnosis of systemic lupus erythematosus (ARA criteria, 1982)
- Patients who fall under WHO class III-IV lupus nephritis on renal biopsy
- Patients with refractory lupus nephritis
- Proteinuria ≥ 0.5 g/day
- Patients who took steroid ≥ 20 mg/day over one month prior to the study
- Patients who failed a first-line therapy (non-responders to steroid monotherapy)
Exclusion Criteria:
- Patients who are allergic or resistant to macrolide antibiotics or tacrolimus
- Patients who received tacrolimus in the past (excluding drugs for external use)
- Patients who used other immunosuppressants within 4 weeks before initiation of the study
- Patients who have been receiving systematic chemotherapy since before enrollment (local chemotherapy is allowed.)
- Patients with malignant tumor which developed within the recent 5 years or history of malignant tumor
- Patients who have severe diarrhea, vomiting, active peptic ulcer or gastrointestinal disorders which may influence absorption of tacrolimus
- Patients with S-Cr ≥ 200 µ㏖/L or ≥ 2.3 mg/dL
- Patients with liver function levels of more than twice the upper limit of normal or acute active hepatitis
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01316133
Contacts
| Contact: Clinical Development Administration Dept. | clinicaltrials_info@jp.astellas.com |
Locations
| Korea, Republic of | |
| Recruiting | |
| Busan, Korea, Republic of | |
| Recruiting | |
| Daegu, Korea, Republic of | |
| Recruiting | |
| Daejeon, Korea, Republic of | |
| Recruiting | |
| Gwangju, Korea, Republic of | |
| Recruiting | |
| Incheon, Korea, Republic of | |
| Recruiting | |
| Jeonju, Korea, Republic of | |
| Recruiting | |
| 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
No publications provided
| Responsible Party: | Astellas Pharma Inc |
| ClinicalTrials.gov Identifier: | NCT01316133 History of Changes |
| Other Study ID Numbers: | PRGLN-10-01-KOR |
| Study First Received: | March 14, 2011 |
| Last Updated: | October 10, 2011 |
| Health Authority: | Korea: Food and Drug Administration |
Keywords provided by Astellas Pharma Inc:
|
Tacrolimus Prograf Calcineurin inhibitor Proteinuria FK506 |
Additional relevant MeSH terms:
|
Lupus Nephritis Nephritis Glomerulonephritis Kidney Diseases Urologic Diseases Lupus Erythematosus, Systemic Connective Tissue Diseases |
Autoimmune Diseases Immune System Diseases Tacrolimus Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013