Ignite Creation Date:
2025-12-24 @ 2:41 PM
Ignite Modification Date:
2026-01-01 @ 9:13 AM
Study NCT ID:
NCT04870359
Status:
COMPLETED
Last Update Posted:
2024-12-16
First Post:
2017-07-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pre-emptive Treatments in Lupus Nephritis Patients With Serological Reactivation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008181', 'term': 'Lupus Nephritis'}], 'ancestors': [{'id': 'D005921', 'term': 'Glomerulonephritis'}, {'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': 'D008180', 'term': 'Lupus Erythematosus, Systemic'}, {'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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 49}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-04-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-13', 'studyFirstSubmitDate': '2017-07-03', 'studyFirstSubmitQcDate': '2021-04-28', 'lastUpdatePostDateStruct': {'date': '2024-12-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Renal Flare', 'timeFrame': 'Within 24 months', 'description': 'A composite endpoint denoted by proteinuria \\>1g/day, presence of urinary RBC \\>30/hpf or RBC casts, or increase in serum creatinine by 15% compared with baseline, and anti-DNA antibody titre above the upper limit of normal'}], 'secondaryOutcomes': [{'measure': 'Infections requiring hospitalization', 'timeFrame': '24 months'}, {'measure': 'Extra-renal flares', 'timeFrame': '24 months'}, {'measure': 'Serum creatinine levels', 'timeFrame': '24 months'}, {'measure': 'Changes in anti-dsDNA', 'timeFrame': '24 months'}, {'measure': 'Changes in C3', 'timeFrame': '24 months'}, {'measure': 'Changes in Hba1c', 'timeFrame': '24 months'}, {'measure': 'Changes in fasting glucose', 'timeFrame': '24 months'}, {'measure': 'Changes in LDL levels', 'timeFrame': '24 months'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lupus Nephritis']}, 'descriptionModule': {'briefSummary': 'The optimal management of asymptomatic serological reactivation (ASR) in lupus nephritis (LN) patients remained undefined. This project aims to investigate the impact of pre-emptive treatment on disease relapse in LN patients who experienced ASR.', 'detailedDescription': 'LN patients who presented with ASR \\[defined as 1) increase in anti-dsDNA \\>100 IU/mL , with or without drop in serum complement; or 2) increase in anti-dsDNA to higher than the normal range and \\>2 times of the preceding value, with or without drop in serum complement; and 3) Absence of renal or systemic manifestations of SLE) will be randomized to receive pre-emptive increase in immunosuppression or had their current immunosuppressive therapies unchanged.\n\nPatients will be followed at 4-, 12-, 24-wk and then every 12 weeks up to 24 months to monitor for renal or extra-renal relapses. Bloods and urine will be collected for measurement of renal and serological parameters, and also B cell signatures.\n\nPrimary outcomes: Renal Flare (denoted as proteinuria \\>1g/D; presence of urinary RBC \\>30 hpf/RBC casts, or increase in SCr \\>15% and positive anti-dsDNA)\n\nSecondary outcomes:\n\n* Safety \\& tolerability of pre-emptive increase of immunosuppressive treatments\n* Extra-renal flares\n* Renal function at 24 months\n* Changes in serological parameters'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with biopsy-proven lupus nephritis who experienced an episode of Asymptomatic Serological Flare (ASF) as defined by:\n\n 1. Increase in anti-dsDNA to \\>100 IU/mL, with or without drop in serum complement levels OR\n 2. Increase in anti-dsDNA to higher than the normal range and more than two times of the preceding value, with or without drop in serum complement levels\n\n AND\n 3. Absence of renal or systemic manifestation of SLE.\n\nExclusion Criteria:\n\n1. Patients who cannot provide informed consent.\n2. Patients whom the clinicians opined to have excessively high risk of infection or malignancy.\n3. Patients who are pregnant or lactating.'}, 'identificationModule': {'nctId': 'NCT04870359', 'briefTitle': 'Pre-emptive Treatments in Lupus Nephritis Patients With Serological Reactivation', 'organization': {'class': 'OTHER', 'fullName': 'The University of Hong Kong'}, 'officialTitle': 'Pre-emptive Increase of Immunosuppressive Treatments in Lupus Nephritis Patients With Asymptomatic Serological Reactivation', 'orgStudyIdInfo': {'id': 'UW-16-074'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Pre-emptive Treatment (Prednisolone and/or AZA/MMF)', 'description': '1. Increase prednisolone to 0.4-0.5 mg/kg/day; taper by 5 mg every 2 weeks to reach 15mg/day; then further reduce by 2.5 mg every 2 week and aim to reach 5-7.5 mg/day after 12 weeks.\n2. Adjustment of the 2nd agent would be as follows:\n\n 1. For patients who receive AZA \\<75mg/day; increase the dose of AZA to 75 mg/day.\n 2. For patients who receive MMF \\<1g/day, increase the dose of MMF to 1g/day.', 'interventionNames': ['Procedure: Pre-emptive increase of immunosuppressive treatments', 'Drug: Prednisolone and/or AZA/MMF']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Current immunosuppressive regimen and dosage should remain unchanged until the development of renal or extra-renal flares which required increase/change in immunosuppression.'}], 'interventions': [{'name': 'Pre-emptive increase of immunosuppressive treatments', 'type': 'PROCEDURE', 'description': '1. Increase prednisolone to 0.4-0.5 mg/kg/day; taper by 5 mg every 2 weeks to reach 15mg/day; then further reduce by 2.5 mg every 2 week and aim to reach 5-7.5 mg/day after 12 weeks.\n2. Adjustment of the 2nd agent would be as follows:\n\n 1. For patients who receive AZA \\<75mg/day; increase the dose of AZA to 75 mg/day.\n 2. For patients who receive MMF \\<1g/day, increase the dose of MMF to 1g/day.', 'armGroupLabels': ['Pre-emptive Treatment (Prednisolone and/or AZA/MMF)']}, {'name': 'Prednisolone and/or AZA/MMF', 'type': 'DRUG', 'description': 'Prednisolone and/or AZA/MMF', 'armGroupLabels': ['Pre-emptive Treatment (Prednisolone and/or AZA/MMF)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'Queen Mary Hospital, Hong Kong', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}, {'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'United Christian Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'overallOfficials': [{'name': 'Desmond YH Yap, MBBS (HK). MD (HK)', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Queen Mary Hospital, The University of Hong Kong'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Hong Kong', 'class': 'OTHER'}, 'collaborators': [{'name': 'United Christian Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}