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

A

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

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

Trial contacts and locations

29

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Central trial contact

Brandy Dupee

Data sourced from clinicaltrials.gov

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