Safety, Tolerability and Renal Effects of APX-115 in Subjects With Type 2 Diabetes and Nephropathy

A

Aptabio Therapeutics, Inc.

Status and phase

Completed
Phase 2

Conditions

Diabetic Nephropathies
Nephropathy, Diabetic
Diabetes Mellitus, Type 2

Treatments

Drug: Placebo
Drug: APX-115

Study type

Interventional

Identifiers

NCT04534439
A01-115-02-EU
2019-004155-37 (EudraCT Number)

Details and patient eligibility

About

This is a proof of concept (PoC) trial to evaluate the safety, tolerability and renal effect of APX-115 in subjects with Type 2 diabetes and nephropathy.

Enrollment

140 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Clinical Diagnosis of type 2 diabetes and nephropathy
  • First morning void (FMV) UACR between 200 and 3000 mg/g, inclusive
  • 30 mL/min/1.73m2 ≤ eGFR ≤ 90 mL/min/1.73m2 using CKD-EPI formula at screening
  • HbA1c ≤ 10% at screening visit
  • Subject who has been taking unchanged dosage of ACE inhibitor or ARB medication for at least 3 months prior to screening and is not anticipated to change its dosage during the course of the study
  • Willing to be under dietary management for diabetes

Exclusion criteria

  • History of type 1 diabetes mellitus or gestational diabetes
  • Subject's renal impairment and/or albuminuria is considered to be of origin other than Diabetic Kidney Disease
  • Subject with uncontrolled blood pressure
  • Clinically significant abnormal laboratory findings
  • History of any cardiovascular event within 6 months prior to screening or cardiovascular procedure planned during the clinical trial
  • Diagnostic or interventional procedure requiring a contrast agent within 4 weeks before the screening visit or planned during the course of the study
  • Clinically significant ECG abnormalities on a 12-lead ECG at the screening visit or before randomization
  • Current or history of NYHA class IV heart failure

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

140 participants in 2 patient groups, including a placebo group

APX-115
Experimental group
Description:
Oral administration of APX-115 400mg, daily
Treatment:
Drug: APX-115
Placebo
Placebo Comparator group
Description:
Oral administration of APX-115-matching placebo 400mg, daily
Treatment:
Drug: Placebo

Trial contacts and locations

16

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Data sourced from clinicaltrials.gov

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