Study of Safety and Efficacy of ANG-3070 in Chronic Kidney Disease

Study Overview
=================
Brief Summary
-----------------
The major objective is to demonstrate the safety and efficacy of ANG-3070 in patients with primary glomerular disease and persistent proteinuria.

Detailed Description
-----------------
To evaluate the safety and efficacy of ANG-3070 in patients with primary glomerular disease and persistent proteinuria while on the SOC, as measured by a reduction in the 24-hour urinary protein excretion.

Official Title
-----------------
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

Conditions
-----------------
Glomerular Disease, Proteinuria

Intervention / Treatment
-----------------
* Drug: ANG-3070
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female participants aged 18 and older. Diagnosis of a primary glomerular disease confirmed from a past renal biopsy. Participants with genetic forms of FSGS may be enrolled without a renal biopsy if the clinical picture is consistent with the genetic testing results. Estimated glomerular filtration rate (eGFR) by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) ≥ 40 mL/min/1.73m2. Urinary protein excretion ≥ 1 g/day on a 24-hour urine collection. All participants must be on the SOC therapy, including the maximally tolerated/recommended doses of an ACEi or ARB, but not both. Exclusion Criteria: Positive Hepatitis B (HBV), Hepatitis C (HCV), or human immunodeficiency virus (HIV) viral screening; historical or during screening. Aspartate Aminotransferase (AST) or alanine Aminotransferase (ALT) or total bilirubin > 2 x ULN. Hemoglobin A1C > 8.5%. Known predisposition to bleeding and/or thrombosis Type I diabetes mellitus. Renal disease secondary to systemic disease including but not limited to: systemic lupus erythematosus, anti-neutrophil cytoplasmic antibodies -associated diseases, anti-glomerular basement disease, secondary forms of focal segmental glomerulosclerosis, renal diseases associated with para-proteinemias, C3 glomerulopathy, and diabetic kidney disease.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 200 mg QD<br>200 mg of ANG-3070 will be taken once daily for 12 weeks. | Drug: ANG-3070<br>* Orally administered tyrosine kinase inhibitor capsule<br>|
| Experimental: 400 mg QD<br>400 mg of ANG-3070 will be taken once daily for 12 weeks | Drug: ANG-3070<br>* Orally administered tyrosine kinase inhibitor capsule<br>|
| Experimental: 300 mg BID<br>300 mg of ANG-3070 will be taken twice a day for 12 weeks. | Drug: ANG-3070<br>* Orally administered tyrosine kinase inhibitor capsule<br>|
| Placebo Comparator: Placebo<br>Placebo capsules will be taken once or twice daily for 12 weeks. | Drug: Placebo<br>* Orally administered placebo capsule<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage change in 24-hour urinary protein excretion at Week 12 |  | Week 12 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Glomerular Disease, Chronic Kidney Disease, Proteinuria