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

Angion

Status and phase: Enrolling; Phase 2

Conditions: Proteinuria; Glomerular Disease

Treatments: Drug: Placebo; Drug: ANG-3070

Study type: Interventional

Funder types: Industry

Identifiers

NCT04939116

ANG3070-CKD-201

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or female participants aged 18 and older.
2. 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.
3. Estimated glomerular filtration rate (eGFR) by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) ≥ 40 mL/min/1.73m2.
4. Urinary protein excretion ≥ 1 g/day on a 24-hour urine collection.
5. All participants must be on the SOC therapy, including the maximally tolerated/recommended doses of an ACEi or ARB, but not both.

Exclusion criteria

1. Positive Hepatitis B (HBV), Hepatitis C (HCV), or human immunodeficiency virus (HIV) viral screening; historical or during screening.
2. Aspartate Aminotransferase (AST) or alanine Aminotransferase (ALT) or total bilirubin > 2 x ULN.
3. Hemoglobin A1C > 8.5%.
4. Known predisposition to bleeding and/or thrombosis
5. Type I diabetes mellitus.
6. 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 4 patient groups, including a placebo group

200 mg QD

Experimental group

Description:

200 mg of ANG-3070 will be taken once daily for 12 weeks.

Treatment:

Drug: ANG-3070

400 mg QD

Experimental group

Description:

400 mg of ANG-3070 will be taken once daily for 12 weeks

Treatment:

Drug: ANG-3070

300 mg BID

Experimental group

Description:

300 mg of ANG-3070 will be taken twice a day for 12 weeks.

Treatment:

Drug: ANG-3070

Placebo

Placebo Comparator group

Description:

Placebo capsules will be taken once or twice daily for 12 weeks.

Treatment:

Drug: Placebo