A Phase 2 Study to Evaluate the Safety, PD, PK, and Clinical Activity of ADX-097 in Participants With IgAN, LN or C3G
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age16+
SponsorAkebia Therapeutics
About this trial
A Phase 2 Study to Evaluate the Safety, Pharmacodynamics, Pharmacokinetics, and Clinical Activity of ADX-097 Administered Subcutaneously in Male and Female Participants Aged 16 Years or Older with Immunoglobulin A Nephropathy (IgAN), Lupus Nephritis (LN), or Complement Component 3 Glomerulopathy (C3G)
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or female participants aged ≥16 years.
uPCR ≥0.5 g/g (from the average of 3 first morning voids [FMVs]).
Screening eGFR ≥30 mL/min/1.73m2 calculated by the Chronic Kidney Disease Epidemiology Collaboration creatinine equation (CKD-EPI GFR).
Participants receiving a renin-angiotensin-aldosterone system (RAAS) inhibitor, sodium-glucose cotransporter-2 (SGLT2) inhibitor, sparsentan, or atrasenten must have been on a stable dose (at the maximum recommended dose according to local guidelines or maximum tolerated dose) for at least 8 weeks prior to Study Day 1 and the dose is projected to remain stable until completion of the study.
Disqualifiers
Rapidly progressive glomerulonephritis defined as a 50% decline in eGFR within 12 weeks of screening.
Concomitant significant renal disease other than IgAN, C3G, or LN per investigator discretion.
Participants with a history of and/or presence of anti-factor H antibodies at screening.
Uncontrolled hypertension with mean seated systolic blood pressure (BP) ≥160 mmHg or diastolic BP ≥100 mmHg based on the average of 2 measurements obtained at approximately 2-minute intervals after the individual has been sitting for 5 minutes.
Trial design
Design model
Single group
Treatments tested in this trial
ADX-097
DrugSubcutaneous Infusions
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Open Label: ADX-097Other 1 intervention
Trial outcomes
Primary outcomes
1
Number of participants reporting treatment emergent adverse events (TEAEs)
Time frame
Up to 30 weeksSecondary outcomes
1
Change from baseline in urine protein-to-creatinine ratio (uPCR)
Time frame
Baseline and up to 26 weeks2
Change from baseline in estimated glomerular filtration rate (eGFR)
Time frame
Baseline and up to 26 weeks3
Trough plasma Concentration of ADX-097
Blood samples will be collected for the analysis of pharmacokinetic parameters at specified timepoints.
Time frame
At Days 1, 8, 22, 50, 78, 106, 134 and 176Sponsors and contacts
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Source ClinicalTrials.gov