Ignite Creation Date:
2025-12-24 @ 11:09 PM
Ignite Modification Date:
2025-12-25 @ 8:43 PM
Study NCT ID:
NCT01206569
Status:
COMPLETED
Last Update Posted:
2012-12-04
First Post:
2010-09-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Long-Acting Tacrolimus for the Treatment of Resistant Lupus Nephritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008181', 'term': 'Lupus Nephritis'}, {'id': 'D005921', 'term': 'Glomerulonephritis'}, {'id': 'D008180', 'term': 'Lupus Erythematosus, Systemic'}], 'ancestors': [{'id': 'D009393', 'term': 'Nephritis'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'completionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-12-03', 'studyFirstSubmitDate': '2010-09-21', 'studyFirstSubmitQcDate': '2010-09-21', 'lastUpdatePostDateStruct': {'date': '2012-12-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-09-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'overall clinical response', 'timeFrame': '6 months', 'description': 'complete response is defined as urinary protein \\< 0.5 g/day, with normal urinary sediment, normal serum albumin, and serum creatinine \\< 15% above the base-line value. Partial response is defined as urinary protein between 0.6 and 2.9 g/day, with a serum albumin \\> 30 g/dL, and stable renal function. No response is defined as urinary protein \\> 3 g/day or a value of 0.6 to 2.9 g/day but serum albumin \\< 30 g/dL, an increase in serum creatinine ≥ 50 µmol/l or 15% above the base-line value, or the discontinuation of treatment due to side effects.'}], 'secondaryOutcomes': [{'measure': 'change in SLEDAI score', 'timeFrame': '6 months'}, {'measure': '24-hour urinary protein excretion', 'timeFrame': '6 months'}, {'measure': 'renal function', 'timeFrame': '6 months'}, {'measure': 'development of lupus flare (renal or non-renal)', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['glomerulonephritis', 'systemic lupus erythematosus'], 'conditions': ['Lupus Nephritis']}, 'descriptionModule': {'briefSummary': 'Glomerulonephritis is one of the major disease manifestations of systemic lupus erythematosus (SLE). Around one-third of the patients, however, do not respond to conventional immunosuppressive therapy, and they have a high risk of progressing to dialysis-dependent renal failure. Recent studies suggest that immunosuppressive therapy targeted against the calcineurin pathway of T-helper cell, for example, tacrolimus, may be effective in the treatment of primary glomerulonephritis. The investigators plan to an open-label single-arm study the efficacy and safety of long-acting tacrolimus in the treatment of treatment-resistant lupus nephritis. Twenty-five patients with biopsy-proven lupus nephritis will be recruited. They will be treated with oral prednisolone and long-acting tacrolimus for 6 months, followed by 6 months of maintenance steroid and azathioprine. Proteinuria, renal function, clinical and serologic lupus activity will be monitored. This study will explore the potential role of long-acting tacrolimus in resistant lupus nephritis, which has a poor prognosis and no effective treatment at the moment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age over 18 with informed consent.\n* Fulfill the revised American College of Rheumatology criteria for SLE\n* Biopsy-proven class III, IV, or V lupus nephritis within the past 24 months.\n* Could not achieve complete remission after at least 4 months of conventional therapy (oral steroid plus cyclosphosphamide or mycophenolate mofetil).\n* NB. Complete response is defined as proteinuria less than 0.5 g/day, with normal urinary sediment, a normal serum albumin concentration, and serum creatinine \\<15% above the base-line value.\n* Female patients of child-bearing age and male patients agree to maintain effective birth control practice during the study.\n\nExclusion Criteria:\n\n* Abnormal liver function tests\n* Hepatitis B surface antigen or hepatitis C antibody positive\n* Diabetic\n* Receiving NSAID or other agents known to influence urinary\n* Protein excretion\n* Allergic or intolerant to macrolide antibiotics or tacrolimus'}, 'identificationModule': {'nctId': 'NCT01206569', 'briefTitle': 'Long-Acting Tacrolimus for the Treatment of Resistant Lupus Nephritis', 'organization': {'class': 'OTHER', 'fullName': 'Chinese University of Hong Kong'}, 'officialTitle': 'Long-Acting Tacrolimus for the Treatment of Resistant Lupus Nephritis', 'orgStudyIdInfo': {'id': 'AFKLN'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'advagraf', 'description': 'Long-acting tacrolimus (Advagraf, Astellas Pharma) will be started at single daily dose of 0.15-0.2 mg/kg/day for 6 months.', 'interventionNames': ['Drug: Long-acting tacrolimus (Advagraf, Astellas Pharma)']}], 'interventions': [{'name': 'Long-acting tacrolimus (Advagraf, Astellas Pharma)', 'type': 'DRUG', 'description': 'Long-acting tacrolimus (Advagraf, Astellas Pharma) will be started at single daily dose of 0.15-0.2 mg/kg/day for 6 months.', 'armGroupLabels': ['advagraf']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shatin', 'country': 'Hong Kong', 'facility': 'Prince of Wales Hospital', 'geoPoint': {'lat': 22.38333, 'lon': 114.18333}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Cheuk-Chun SZETO', 'investigatorAffiliation': 'Chinese University of Hong Kong'}}}}