Recruiting
Phase 2

Formoterol Fumarate

Sponsor:

Medical University of South Carolina

Code:

NCT07022418

Conditions

Diabetic Nephropathies

Diabetic Kidney Disease

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Formoterol furmarate (20 μg)

Study Details

Brief 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

Study ID

NCT07022418

Start date

Dec 1, 2025

Status verified date

Nov, 2025

Completion date

Nov, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Adults aged 18-75
  • Diagnosis of type 2 diabetes according to American Diabetes Association (ADA) criteria
  • On stable medical therapy for at least 3 months
  • Stage CKD G2 to G3b; A2-A3 as defined by eGFR with no requirement for renal biopsy for diagnosis
  • Diabetic kidney disease as per Nephrologist
  • Urinary albumin to creatinine excretion rate (UACR) 200-5000 mg/g/24hrs on at least two occasions (one of these can be a spot UACR)
  • HbA1c <8%
  • Receiving stable doses of ACE inhibitor or ARB therapy prior to screening (at least 3 months, unless contraindicated) and/or a stable dose of an SGLT inhibitor (at least 3 months preceding enrollment)
  • Receiving stable doses of all additional anti-HTN medications, insulin, oral and injectable non-insulin agents and cholesterol lowering medications at least 3 months prior (unless contraindicated) to randomization and agree to maintain until the study's conclusion.
  • Willing and able to comply with schedule of events and protocol requirements, including written informed consent.

Exclusion Criteria:

  • Female subjects who are pregnant or breast feeding or who plan on becoming pregnant
  • Currently take beta-agonists
  • Organ transplant recipients
  • Any history of New York Heart Association (NYHA) class III/IV heart failure or recent history of serious heart problem (CABG, stroke, MI) in the past 12 months
  • Any history of asthma
  • Patients with serum potassium levels <3.5 mEQ/L
  • Patients with uncontrolled HTN SBP >150mmHg, DBP >95mmHg
  • EKG showing QTc elongation or tachyarrhythmia; including sinus tachycardia >100bpm
  • Contraindications to formoterol fumarate (hypersensitivity, including patients with known hypersensitivity to ACE inhibitors or ARBs)
  • Advanced organ failure
  • Untreated/uncontrolled cardiovascular, pulmonary, or gastrointestinal disease
  • Patients with BMI >50
  • Active untreated cancer
  • Alcohol or drug abuse in the past 6 months
  • Being involuntarily incarcerated
  • Participating in another interventional study
  • Unable or unwilling to do the 36-week intervention

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: Standard of Care Only

Standard of Care Treatment Only

experimental: Formoterol Fumarate + Standard of Care Treatment

Formoterol Fumarate Inhalation Solution as one 20 mcg unit-dose vial administered twice daily (morning and evening) by nebulization (in addition to standard of care treatment)

Interventions

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.

Primary outcome measure

  • Feasibility: refusal rate and adherence during the 36-week treatment [ Time Frame: 36 weeks ]
  • To assess the safety, tolerability, and acceptability of the intervention with formoterol [ Time Frame: 36 Weeks ]
  • To perform preliminary efficacy testing and determine the variability of albuminuria [ Time Frame: 36 Weeks ]
  • To perform preliminary efficacy testing and determine the variability of eGFR. [ Time Frame: 36 Weeks ]

Central Contacts and Locations

Central contacts

Recruitment Contact

(843) 792-0965recruitment@musc.edu

Locations

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Recruitment

8437920965recruitment@musc.edu

More Information

Sponsor

Medical University of South Carolina

Last update posted

Feb 5, 2026

Last verified

Nov, 2025

Keywords

  • Diabetes

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Medical University of South Carolina on 2026-02-05.