Formoterol in Diabetes

NCT07022418 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-02-05

No results posted yet for this study

Summary

The purpose of the study is to evaluate if formoterol fumarate is effective in treating patients with diabetic kidney disease. Study participants will be randomly assigned to either receive formoterol fumarate (in addition to their current standard of care treatment) or standard of care treatment only. Study participants will have a 50% chance of receiving formoterol fumarate and a 50% chance of not receiving formoterol fumarate. Both groups will continue their standard of care treatment during the study. The primary goal is to gather data on feasibility and effect sizes to properly power a future clinical trial.

Conditions

  • Diabetic Nephropathies
  • Diabetic Kidney Disease

Interventions

DRUG

Formoterol furmarate (20 μg)

Investigators chose to use the long-acting β2-AR agonist, formoterol, because of its efficacy and safety profile in patients with COPD and because formoterol showed the most association with protection from progression of CKD in our retrospective study.

Sponsors & Collaborators

  • Dialysis Clinic, Inc.

    collaborator INDUSTRY
  • Medical University of South Carolina

    lead OTHER

Principal Investigators

  • Joshua Lipschutz, MD · Medical University of South Carolina

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2025-12-01
Primary Completion
2026-12-31
Completion
2027-11-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT07022418 on ClinicalTrials.gov