[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656055":3},{"organization":4,"outcomesModule":7,"designInfo":46,"detailedDescription":49,"studyPopulation":49,"armGroups":53,"interventions":60,"overallOfficials":68,"centralContacts":72,"locations":82,"responsibleParty":102,"collaborators":104,"id":116,"slug":117,"hasResults":118,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":122,"eligibilityCriteria":123,"healthyVolunteers":118,"sex":124,"minAge":125,"maxAge":49,"enrollmentInfo":126,"targetDuration":49,"studyType":129,"phases":130,"briefSummary":132,"conditions":133,"keywords":136,"overallStatus":147,"whyStopped":49,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":157},{"fullName":5,"class":6},"University of Illinois at Chicago","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":18},[9],{"measure":10,"description":11,"timeFrame":12},"Proportion of participants achieving improvement in at least one component of the composite kidney mpMRI endpoint at Month 6","The proportion of participants with improvement from baseline at Month 6 in at least one of: ≥5% decrease in cortical native T1 mapping time; ≥5% increase in cortical apparent diffusion coefficient (ADC); or ≥10% increase in phase-contrast-derived renal artery blood flow.","Baseline to Month 6 (Week 26)",[14],{"measure":15,"description":16,"timeFrame":17},"Percent change from baseline in urinary KIM-1 and MCP-1 over 6 months","Percent change from baseline in urine biomarkers Kidney Injury Molecule-1 (KIM-1) and Monocyte Chemoattractant Protein-1 (MCP-1), assessed individually and\u002For as a composite.","Baseline through Month 6",[19,23,26,29,33,37,40,43],{"measure":20,"description":21,"timeFrame":22},"Composite kidney mpMRI endpoint at Month 12","Change from baseline in composite and individual imaging biomarkers; Month 12.","Baseline to month 12",{"measure":24,"description":25,"timeFrame":22},"Imaging biomarker trajectory over 12 months","Geometric mean percent change from baseline in composite and individual imaging biomarkers at Month 6 and Month 12.",{"measure":27,"description":28,"timeFrame":22},"Urine and blood biomarkers over 12 months","Geometric mean percent change from baseline at Weeks 4, 12, 26 and 52.",{"measure":30,"description":31,"timeFrame":32},"Imaging biomarker slopes","Change over time from baseline to Month 12 in T1 mapping, ADC and phase-contrast renal artery blood flow.","baseline to Month 12",{"measure":34,"description":35,"timeFrame":36},"Urine\u002Fblood biomarker slopes","Change over time from baseline to Month 12 in composite and individual biomarkers.","Baseline to Month 12",{"measure":38,"description":39,"timeFrame":36},"Histopathology in biopsy cohort","Change from baseline to Month 12 in MEST-C scoring and histopathologic staining in the nested repeat-biopsy cohort.",{"measure":41,"description":42,"timeFrame":36},"Tissue expression profiles in biopsy cohort","Change from baseline to Month 12 in regional proteomics, transcriptomics and single-cell\u002Fnucleus RNA sequencing expression profiles.",{"measure":44,"description":45,"timeFrame":22},"Correlation with clinical kidney measures","Correlation of changes in UPCR and eGFR with imaging and biochemical biomarker outcomes.",{"allocation":47,"interventionModel":48,"interventionModelDescription":49,"primaryPurpose":50,"observationalModel":49,"timePerspective":49,"maskingInfo":51},"NA","SINGLE_GROUP",null,"TREATMENT",{"masking":52,"maskingDescription":49,"whoMasked":49},"NONE",[54],{"label":55,"type":56,"description":57,"interventionNames":58},"Atrasentan","EXPERIMENTAL","Adults with biopsy-confirmed IgAN receive atrasentan 0.75 mg orally once daily for 52 weeks in addition to optimized supportive care. The optional repeat-biopsy cohort is nested within this arm and is not a separate randomized arm.",[59],"Drug: atrasentan",[61],{"type":62,"name":63,"description":64,"armGroupLabels":65,"otherNames":66},"DRUG","atrasentan","Atrasentan 0.75 mg oral tablet once daily for 52 weeks, added to optimized supportive care.",[55],[67],"vanrafia",[69],{"name":70,"affiliation":5,"role":71},"Anand Srivastava, MD, MPH","PRINCIPAL_INVESTIGATOR",[73,78],{"name":74,"role":75,"phone":76,"phoneExt":49,"email":77},"Kimberly Silva, MPH","CONTACT","312-996-0185","ksilva4@uic.edu",{"name":79,"role":75,"phone":80,"phoneExt":49,"email":81},"Natalie Meza, MPH","3129966033","nmeza1@uic.edu",[83],{"facility":84,"status":49,"city":85,"state":86,"zip":87,"country":88,"countryCode":89,"cosmosGeoPoint":90,"geoPoint":95,"contacts":96},"University of Illinois Chicago","Chicago","Illinois","60612","United States","US",{"type":91,"coordinates":92},"Point",[93,94],-87.65005,41.85003,{"lat":94,"lon":93},[97,100,101],{"name":70,"role":75,"phone":98,"phoneExt":49,"email":99},"312-355-0627","asrivast@uic.edu",{"name":74,"role":75,"phone":76,"phoneExt":49,"email":77},{"name":70,"role":71,"phone":49,"phoneExt":49,"email":49},{"type":103,"investigatorFullName":49,"investigatorTitle":49,"investigatorAffiliation":49,"oldNameTitle":49,"oldOrganization":49},"SPONSOR",[105,108,110,112,114],{"name":106,"class":107},"Novartis","INDUSTRY",{"name":109,"class":6},"University of Michigan",{"name":111,"class":6},"Endeavor Health",{"name":113,"class":6},"University of North Carolina, Chapel Hill",{"name":115,"class":6},"Icahn School of Medicine at Mount Sinai","100656055","phase-4-mechanistic-evaluation-of-atrasentan-in-patients-with-iga-nephropathy-igan-100656055",false,"NCT07820995","Mechanistic Evaluation of Atrasentan in Patients With IgA Nephropathy (IgAN)","A Multicenter, Single Arm, Open Label, Pilot Study to Assess the Effect of Atrasentan Alongside Supportive Care on Structural and Functional Changes in Kidneys of Adult Patients With IgA Nephropathy (IgAN)","A-MECH","Inclusion Criteria:\n\n1. Signed informed consent.\n2. Male or female ≥18 years with biopsy-confirmed IgAN; eGFR ≥30 mL\u002Fmin\u002F1.73 m² for main cohort; \\>40 mL\u002Fmin\u002F1.73 m² for optional biopsy cohort.\n3. Screening UPCR ≥0.5 g\u002Fg measured by first morning void.\n4. Maximally tolerated or locally approved maximal ACEi\u002FARB dose before enrollment; diuretics, other antihypertensives and SGLT2i, if used, stabilized for at least 90 days before baseline.\n5. WOCBP and sexually active participants must comply with protocol contraception requirements.\n\nExclusion Criteria:\n\n1. Hypersensitivity to study treatment\u002Fexcipients or similar drug classes.\n2. CKD primarily attributable to non-IgAN etiology.\n3. Suspected RPGN or IgA vasculitis.\n4. Nephrotic syndrome.\n5. BNP \\>200 pg\u002FmL or NT-proBNP \\>450 pg\u002FmL at screening.\n6. Platelets \\\u003C80,000\u002FµL.\n7. Organ transplant history other than corneal transplant.\n8. Systemic immunosuppressants \\>2 weeks in prior 3 months or rituximab within 6 months.\n9. Confirmed BP \\>150\u002F95 mmHg based on mean of 3 screening measurements.\n10. Heart failure\u002Ffluid overload.\n11. Significant liver disease or transaminases\u002Fbilirubin \\>2× ULN.\n12. Hemoglobin \\\u003C9 g\u002FdL or transfusion for anemia within 3 months.\n13. Malignancy unless protocol-defined exception.\n14. Pregnancy\u002Fbreastfeeding or intent to become pregnant.\n15. Male intent to father a child\u002Fdonate sperm during study and 1 month after.\n16. Recent investigational\u002Fapproved IgAN treatment per protocol washout.\n17. Clinically significant unstable\u002Funcontrolled medical disorder that may confound results or add risk.\n18. Alcohol\u002Fillicit drug-related disorder within 3 years.\n19. WOCBP not using highly effective contraception; sexually active males unwilling to use condoms.\n20. Prohibited therapies.\n21. MRI contraindications.\n22. Optional biopsy cohort exclusion if biopsy risk is unacceptably high.","ALL","18 Years",{"count":127,"type":128},20,"ESTIMATED","INTERVENTIONAL",[131],"PHASE4","This multicenter, single-arm, open-label Phase 4 pilot study evaluates the effects of atrasentan added to optimized supportive care on kidney structure and function in adults with biopsy-confirmed IgA nephropathy. Approximately 20 participants will receive atrasentan 0.75 mg orally once daily for 52 weeks. Kidney multiparametric MRI is performed at baseline, 6 months, and 12 months, with blood and urine biomarker assessments throughout treatment. An optional nested cohort of up to 5 participants undergoes native kidney biopsy at baseline and 12 months.",[134,135],"IgA Nephropathy (IgAN)","Immunoglobulin A Nephropathy (IgAN)",[137,63,138,139,140,141,142,143,144,145,146],"IgA nephropathy","multiparametric MRI","MRI","biomarkers","kidney injury","mechanistic","fibrosis","renal blood flow","kidney biopsy","histopathology","NOT_YET_RECRUITING","2026-09-15",{"date":150,"type":151},"2026-09-21","ACTUAL",{"date":153,"type":128},"2026-09-29",{"date":155,"type":128},"2028-12-31",{"name":5,"class":6},1]