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

NCT04534439 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2021-08-25

No results posted yet for this study

Summary

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.

Conditions

  • Diabetic Nephropathies
  • Diabetes Mellitus, Type 2
  • Nephropathy, Diabetic

Interventions

DRUG

APX-115

oral administration of APX-115 400mg capsule once daily for 12 weeks

DRUG

Placebo

oral administration of APX-115-matching placebo 400mg capsule once daily for 12 weeks

Sponsors & Collaborators

  • Aptabio Therapeutics, Inc.

    lead INDIV

Principal Investigators

  • Istavan Wittmann, MD · University of Pecs

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-24
Primary Completion
2021-07-26
Completion
2021-08-23

Countries

  • Bulgaria
  • Czechia
  • Hungary
  • Serbia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04534439 on ClinicalTrials.gov