[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100651326":3},{"organization":4,"armGroups":7,"interventions":31,"overallOfficials":27,"centralContacts":27,"locations":59,"responsibleParty":84,"collaborators":27,"id":87,"slug":88,"hasResults":89,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":93,"eligibilityCriteria":94,"healthyVolunteers":95,"sex":96,"minAge":97,"maxAge":98,"enrollmentInfo":99,"targetDuration":27,"studyType":102,"phases":103,"briefSummary":105,"conditions":106,"keywords":109,"overallStatus":62,"whyStopped":27,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":127},{"fullName":5,"class":6},"Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)","OTHER",[8,19,23,28],{"label":9,"type":10,"description":11,"interventionNames":12},"Triple Therapy (MMF + Prednisolone + Voclosporin)","ACTIVE_COMPARATOR","Participants receive induction corticosteroid therapy consisting of intravenous methylprednisolone 500 mg daily for 3 days, followed by oral prednisolone 1 mg\u002Fkg\u002Fday with tapering to ≤5 mg\u002Fday within 3 months, mycophenolate mofetil (MMF) 1000 mg twice daily (or 500 mg four times daily), and voclosporin 23.7 mg twice daily.",[13,14,15,16,17,18],"Procedure: Kidney Biopsy","Drug: Voclosporin (LUPKYNIS)","Diagnostic Test: Blood, feces and urine sample collection","Other: LupusPRO questionnaire","Drug: Mycophenolate Mofetil (MMF) Treatment","Drug: Prednisolone",{"label":20,"type":10,"description":21,"interventionNames":22},"Dual Therapy (MMF + Prednisolone)","Participants receive induction corticosteroid therapy consisting of intravenous methylprednisolone 500 mg daily for 3 days, followed by oral prednisolone 1 mg\u002Fkg\u002Fday with tapering to ≤5 mg\u002Fday within 3 months, and mycophenolate mofetil (MMF) 1000 mg twice daily (or 500 mg four times daily).",[13,15,16,17,18],{"label":24,"type":25,"description":26,"interventionNames":27},"SLE without LN control","NO_INTERVENTION","From the SLE without LN patients (disease control), blood and urine samples are collected at two timepoints, with an interval of (min) 3 and (max) 6 months between collection. Participants in this arm are not randomized and do not undergo treatment or kidney biopsy.",null,{"label":29,"type":25,"description":30,"interventionNames":27},"Healthy control","Healthy participants (healthy control) blood and urine samples are collected at two timepoints, with an interval of (min) 3 and (max) 6 months between collection. Participants in this arm are not randomized and do not undergo treatment or kidney biopsy.",[32,37,42,47,51,55],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":27},"PROCEDURE","Kidney Biopsy","At 3 months after the start of treatment, participants will undergo a repeat renal biopsy for assessment of early histological response and for single-cell RNA sequencing.",[20,9],{"type":38,"name":39,"description":40,"armGroupLabels":41,"otherNames":27},"DRUG","Voclosporin (LUPKYNIS)","Arm 1 will receive triple therapy (addition of voclosporin)",[9],{"type":43,"name":44,"description":45,"armGroupLabels":46,"otherNames":27},"DIAGNOSTIC_TEST","Blood, feces and urine sample collection","Blood, feces and urine samples will be collected at multiple timepoints during study follow-up period.",[20,9],{"type":6,"name":48,"description":49,"armGroupLabels":50,"otherNames":27},"LupusPRO questionnaire","The lupusPRO v1.7 questionnaire (20) is a 43-question patient reported outcome survey tool to follow the impact of lupus or its treatment on the patient's quality of life. The questionnaire takes 7-8 minutes to complete and is validated and available in multiple languages. Participants will be asked to either fill in the questionnaire at home (and bring it on their next outpatient clinic visit) or while visiting the hospital during follow-up time. The questionnaires are filled in on paper.",[20,9],{"type":38,"name":52,"description":53,"armGroupLabels":54,"otherNames":27},"Mycophenolate Mofetil (MMF) Treatment","MMF 1000 mg twice daily (or 500 mg four times daily)",[20,9],{"type":38,"name":56,"description":57,"armGroupLabels":58,"otherNames":27},"Prednisolone","Following intravenous methylprednisolone induction (500mg, 3 days), oral prednisolone 1 mg\u002Fkg\u002Fday tapered to ≤5 mg\u002Fday within 3 months.",[20,9],[60],{"facility":61,"status":62,"city":63,"state":27,"zip":27,"country":64,"countryCode":65,"cosmosGeoPoint":66,"geoPoint":71,"contacts":72},"Amsterdam University Medical Center","RECRUITING","Amsterdam","Netherlands","NL",{"type":67,"coordinates":68},"Point",[69,70],4.88969,52.37403,{"lat":70,"lon":69},[73,78,81],{"name":74,"role":75,"phone":76,"phoneExt":27,"email":77},"Marc L Hilhorst, Principal Investigator","CONTACT","+31205669111","m.l.hilhorst@amsterdamumc.nl",{"name":79,"role":80,"phone":27,"phoneExt":27,"email":27},"Marc L Hilhorst, MD, PhD","PRINCIPAL_INVESTIGATOR",{"name":82,"role":83,"phone":27,"phoneExt":27,"email":27},"Suryanti D Crum, MD","SUB_INVESTIGATOR",{"type":80,"investigatorFullName":85,"investigatorTitle":86,"investigatorAffiliation":5,"oldNameTitle":27,"oldOrganization":27},"Marc L. Hilhorst","MD, PhD","100651326","phase-4-assessing-residual-inflammation-and-macrophage-presence-in-lupus-nephritis-after-3-months-of-intensified-treatment-with-prednisolone-mycofenolate-mofetil-and-voclosporin-as-compared-to-mycofenolate-mofetil-and-prednisolone-100651326",false,"NCT07760480","Assessing Residual Inflammation and Macrophage Presence in Lupus Nephritis After 3 Months of Intensified Treatment With Prednisolone, Mycofenolate Mofetil and Voclosporin as Compared to Mycofenolate Mofetil and Prednisolone","Assessing Residual Inflammation and Macrophage Presence in Lupus Nephritis After 3 Months of Intensified Treatment With Prednisolone, Mycofenolate Mofetil and Voclosporin as Compared to Mycofenolate Mofetil and Prednisolone, an Open Label Randomized Controlled Trial","MAPLE","Lupus nephritis patients\n\nInclusion Criteria:\n\n* Patients with de novo or flaring SLE according to the EULAR\u002FACR criteria and a suspicion of class III or IV LN with a clinical indication to perform a kidney biopsy\n* Age 16-70 years\n* eGFR as measured by cystatin C \\>20 mL\u002Fmin\n\nExclusion Criteria:\n\n* LN class I, II or pure class V upon kidney biopsy\n* eGFR as measured by cystatin C \\\u003C20 mL\u002Fmin\n* Histological chronicity score (NIH) of 8 or higher in the kidney biopsy\n* Active infection of any kind as evidenced by cultures (blood, urine or otherwise)\n* History of hepatitis B, hepatitis C, tuberculosis and\u002For HIV\n* Treatment with any of the following agents within one month before screening:\n\ntacrolimus, belimumab, anifrolumab - Treatment with any of the following agents within 6 months before screening: rituximab, daratumumab, eculizumab\n\n* Prolongation of QT-interval (QTc \\>470ms) and\u002For bradycardia (resting heart rate \\\u003C50bpm) measured on two separate occasions\n* Hyperkalaemia (serum potassium \\>6.0 mmol\u002FL)\n* Hypertension (blood pressure \\> 165\u002F105 mmHg, with symptoms of hyperten sion)\\*\n* Co-administration of voclosporin with strong CYP3A4 inhibitors (e.g., ke toconazole, itraconazole, clarithromycin)\n* Pregnancy\n\n  * A single elevated blood pressure measurement will not lead to immediate exclusion from the trial. Antihypertensive therapy may be initiated as appropriate. Dose adjustments of voclosporin should be made in accordance with Section 11.3.2 of the protocol\n\nSLE patients without LN (disease control group) Inclusion criteria\n\n* Diagnosis of SLE according to EULAR\u002FACR guidelines\n* Age 16-70\n\nExclusion criteria\n\n* Suspicion of LN\n* Signs of active infection\n\nHealthy subjects (control group) Inclusion criteria\n\n* Blank medical history\n* Age 16-70\n* A majority (75%) of female healthy subjects will be sought\n\nExclusion criteria\n\n\\- Signs of active infection",true,"ALL","16 Years","70 Years",{"count":100,"type":101},55,"ESTIMATED","INTERVENTIONAL",[104],"PHASE4","The goal of this clinical trial is to learn how different treatments affect immune cells in the kidney in people with active lupus nephritis (LN), a kidney manifestation of systemic lupus erythematosus (SLE). It will also investigate whether early changes in kidney tissue can predict long-term treatment response and whether blood or urine biomarkers can be used to monitor disease activity without the need for repeat kidney biopsies.\n\nThe main questions it aims to answer are:\n\n* Does adding voclosporin to standard treatment with mycophenolate mofetil (MMF) and prednisolone result in greater early improvement of kidney inflammation compared with MMF and prednisolone alone?\n* Are specific macrophage and monocyte populations associated with treatment response and long-term kidney outcomes?\n* Can blood- or urine-based biomarkers be identified that reflect kidney inflammation and treatment response?\n\nResearchers will compare MMF, prednisolone, and voclosporin (triple therapy) with MMF and prednisolone alone (dual therapy) to determine whether intensified treatment leads to faster and more complete immunological and histological remission.\n\nParticipants with newly diagnosed or relapsing proliferative lupus nephritis will:\n\n* Be randomly assigned to receive either triple therapy (MMF, prednisolone, and voclosporin) or dual therapy (MMF and prednisolone).\n* Undergo a kidney biopsy before treatment starts and a repeat kidney biopsy after 3 months of treatment.\n* Provide blood and urine samples during follow-up for immune cell analyses and biomarker studies.\n* Complete patient-reported outcomes questionnaires\n* Attend regular study visits and clinical assessments for up to 2 years.\n\nIn addition, participants with SLE without lupus nephritis and healthy volunteers will provide blood samples to allow comparison of circulating immune cell populations between groups.",[107,108],"Lupus Nephritis","Systemic Lupus Erythematosus (SLE)",[107,110,111,112,113,114,115,116,117],"LN","SLE","Systemic lupus erythematosus","volcosporin","mmf","cellcept","prednisolone","kidney biopsy","2026-08-10",{"date":120,"type":121},"2026-08-12","ACTUAL",{"date":123,"type":121},"2026-04-23",{"date":125,"type":101},"2030-04",{"name":5,"class":6},1]