A Phase 2 Multicenter Double-Blind Randomized Placebo-controlled Study of Safety and Efficacy Of ANG-3070 in Patients with Primary Glomerular Disease and Persistent Proteinuria.
Are you eligible to participate in this study?
You may be eligible for this study if you meet the following criteria:
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Conditions: Patients With Primary Glomerular Disease And Persistent Proteinuria
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Age: Between 18 - 100 Years
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Gender: Male or Female
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Other Inclusion Criteria:
- Diagnosis of IgA nephropathy or primary FSGS
- Estimated glomerular filtration rate (eGFR) by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) = 30 mL/min/1.73m2
- Urinary protein excretion, as measured by UPCR (geometric mean of 3 first-void urine), per threshold values below:
- a. IgA nephropathy: = 750 mg/g or 85 mg/mmol of creatinine
- b. FSGS: = 1000 mg/g or 113 mg/mmol of creatinine
- Stable blood pressure = 140/90 mmHg with stable antihypertensive regimen for at least 12 weeks prior to screening
- All participants must be on the SOC therapy, including the maximally tolerated/recommended doses of an ACEi or ARB, but not both.
- Renin-angiotensin-aldosterone system (RAAS) blockers and Sodium glucose cotransporter 2 (SGLT-2) inhibitors must be stable
- Immunosuppressive or immunomodulatory therapy must be stable
- Both genders of childbearing potential must agree to use adequate contraception
- Participants must be willing and able to give written Informed Consent and to comply with protocol requirements
- Participants must be judged to be otherwise fit for the study by the Investigator
You may not be eligible for this study if the following are true:
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- Diagnosis of IgA nephropathy or primary FSGS
- Estimated glomerular filtration rate (eGFR) by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) = 30 mL/min/1.73m2
- Urinary protein excretion, as measured by UPCR (geometric mean of 3 first-void urine), per threshold values below:
- a. IgA nephropathy: = 750 mg/g or 85 mg/mmol of creatinine
- b. FSGS: = 1000 mg/g or 113 mg/mmol of creatinine
- Stable blood pressure = 140/90 mmHg with stable antihypertensive regimen for at least 12 weeks prior to screening
- All participants must be on the SOC therapy, including the maximally tolerated/recommended doses of an ACEi or ARB, but not both.
- Renin-angiotensin-aldosterone system (RAAS) blockers and Sodium glucose cotransporter 2 (SGLT-2) inhibitors must be stable
- Immunosuppressive or immunomodulatory therapy must be stable
- Both genders of childbearing potential must agree to use adequate contraception
- Participants must be willing and able to give written Informed Consent and to comply with protocol requirements
- Participants must be judged to be otherwise fit for the study by the Investigator
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