IgA Nephropathy (IgAN)
Conditions
Interventions
Study setting: Sri Jayewardenepura General Hospital, National Hospital of Sri Lanka, The National Institute of Nephrology, Dialysis and Transplantation and Colombo North Teaching Hospital.
Study drug
Sponsors
Eledon Pharmaceuticals, Inc
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female >18 years of age 2. Biopsy proven IgAN 3. Urine protein > 0.75g/24 hours at Screening despite optimization with ACE inhibitors or angiotensin receptor blockers (ARB) 4. eGFR >45 mL/min per 1.73 m2 or eGFR 30 mL/min per 1.73 m2 with a kidney biopsy within 2 years of Screening showing < 50% tubulointerstitial fibrosis 5. Agree to comply with contraception requirements during and for 90 days after study completion.
Exclusion criteria
Exclusion criteria: 1. Any secondary IgAN as defined by the investigator 2. Patients who have undergone a kidney transplant 3. Any history of kidney disease other than IgAN 4. Any history of diabetes (Type 1 or Type 2) 5. Seated blood pressure > 140 mmHg (systolic) or > 90 mmHg (diastolic) at the Screening Visit. Patients must be on a stable dose and regimen of an ACE inhibitor or ARB for at least 90 days 6. Significant liver disease,; 7. Pregnancy or breastfeeding; 8. Concurrent participation in another interventional study or treatment with an investigational drug
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy: Change in 24 hour urine protein to creatinine ratio (UPCR) participants [Time Frame: Up to 24 weeks ] Safety: Number of participants with treatment related serious adverse events, treatment emergent adverse events (TEAE’s) and AE’s of special interest (AEoSI) which include: •Anaphylaxis •Any thromboembolic (TE) event •Bleeding •Fungal and opportunistic infections •Malignancy [ Time Frame: Through study completion, an average of 100 weeks] Safety: Changes in vital signs, electrocardiogram changes (ECG) and clinical laboratory measures [ Time Frame: Through study completion, an average of 100 weeks] [] [] | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in eGFR slope [Time Frame: Baseline- 96 weeks ] Change in urine protein excretion (mg/mg) [ Time Frame: Up to 96 weeks ] Development of Anti drug Antibodies (ADAs) [ Time Frame: Up to 96 weeks ] [] [] | — |
Countries
Australia,China,Croatia,Malaysia,New Zealand,Philippines,Poland,Spain,Sri Lanka,Thailand,United Kingdom,United States
Contacts
Public ContactDr. Chula Herath
Consultant Nephrologist
Outcome results
None listed