Mechanistic Evaluation of Atrasentan in Patients With IgA Nephropathy (IgAN)
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Illinois at Chicago
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Signed informed consent.
Male or female ≥18 years with biopsy-confirmed IgAN; eGFR ≥30 mL/min/1.73 m² for main cohort; >40 mL/min/1.73 m² for optional biopsy cohort.
Screening UPCR ≥0.5 g/g measured by first morning void.
Maximally tolerated or locally approved maximal ACEi/ARB dose before enrollment; diuretics, other antihypertensives and SGLT2i, if used, stabilized for at least 90 days before baseline.
Disqualifiers
Hypersensitivity to study treatment/excipients or similar drug classes.
CKD primarily attributable to non-IgAN etiology.
Suspected RPGN or IgA vasculitis.
Nephrotic syndrome.
Trial design
Design model
Single group
Treatments tested in this trial
atrasentan
DrugAtrasentan 0.75 mg oral tablet once daily for 52 weeks, added to optimized supportive care.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: AtrasentanExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline to Month 6 (Week 26)Secondary outcomes
1
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/or as a composite.
Time frame
Baseline through Month 6Other outcomes
1
Composite kidney mpMRI endpoint at Month 12
Change from baseline in composite and individual imaging biomarkers; Month 12.
Time frame
Baseline to month 122
Imaging biomarker trajectory over 12 months
Geometric mean percent change from baseline in composite and individual imaging biomarkers at Month 6 and Month 12.
Time frame
Baseline to month 123
Urine and blood biomarkers over 12 months
Geometric mean percent change from baseline at Weeks 4, 12, 26 and 52.
Time frame
Baseline to month 124
Imaging biomarker slopes
Change over time from baseline to Month 12 in T1 mapping, ADC and phase-contrast renal artery blood flow.
Time frame
baseline to Month 12Sponsors and contacts
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University of Illinois at Chicago
Lead sponsor
Novartis
Collaborator
University of Michigan
Collaborator
Endeavor Health
Collaborator
University of North Carolina, Chapel Hill
Collaborator
Icahn School of Medicine at Mount Sinai
Collaborator
Source ClinicalTrials.gov
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