Actively Recruiting
Prospective Randomized Pilot Trial of Formoterol in Patients With Diabetic Kidney Disease
Led by Medical University of South Carolina · Updated on 2026-02-05
120
Participants Needed
1
Research Sites
47 weeks
Total Duration
On this page
Sponsors
M
Medical University of South Carolina
Lead Sponsor
D
Dialysis Clinic, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the potential of formoterol fumarate in treating patients with diabetic kidney disease. This phase 2 randomized trial aims to assess the feasibility, safety, and preliminary effectiveness of adding formoterol fumarate to the standard care for diabetic nephropathy. The study builds on promising preclinical and retrospective data suggesting formoterol may help restore kidney function and slow disease progression in diabetes-related kidney damage. Participants will be randomly assigned to one of two groups: one group will receive formoterol fumarate inhalation solution twice daily via nebulization along with their usual standard of care treatment, while the other group will continue with standard of care treatment only. This treatment phase lasts 36 weeks. The trial also includes safety monitoring and assessments up to 40 weeks. Throughout the study, participants will undergo various evaluations including laboratory tests for kidney function (eGFR and urine albumin), blood sugar (HbA1c), and heart monitoring (EKG, blood pressure, heart rate). Researchers will track adherence, tolerability, safety, and changes in kidney function to understand the treatment's impact. The total study duration includes treatment and follow-up assessments over approximately 40 weeks.
CONDITIONS
Brief Title
Formoterol in Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 75 years
- Diagnosis of type 2 diabetes according to American Diabetes Association criteria
- On stable medical therapy for at least 3 months
- Stage CKD G2 to G3b; A2-A3 as defined by eGFR without need for renal biopsy
- Diagnosed with diabetic kidney disease by a nephrologist
- Urinary albumin to creatinine excretion rate between 200-5000 mg/g/24hrs on at least two occasions
- HbA1c less than 8%
- Receiving stable doses of ACE inhibitor or ARB therapy for at least 3 months unless contraindicated
- Receiving stable doses of other anti-hypertensive medications, insulin, oral or injectable non-insulin agents, and cholesterol lowering medications for at least 3 months unless contraindicated
- Willing and able to comply with study schedule and provide informed consent
You will not qualify if you...
- Female participants who are pregnant, breastfeeding, or planning pregnancy
- Current use of beta-agonist medications
- Organ transplant recipients
- History of NYHA class III/IV heart failure or serious heart events within past 12 months
- History of asthma
- Serum potassium levels below 3.5 mEQ/L
- Uncontrolled hypertension with systolic BP over 150 mmHg or diastolic BP over 95 mmHg
- EKG showing QTc prolongation, tachyarrhythmia, or sinus tachycardia over 100 bpm
- Known hypersensitivity to formoterol fumarate, ACE inhibitors, or ARBs
- Advanced organ failure
- Untreated or uncontrolled cardiovascular, pulmonary, or gastrointestinal disease
- Body mass index over 50
- Active untreated cancer
- Alcohol or drug abuse within past 6 months
- Involuntary incarceration
- Participation in another interventional study
- Unable or unwilling to complete the 36-week intervention
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 36 weeks
Participants receive formoterol fumarate inhalation solution twice daily by nebulization in addition to standard care, or standard care alone, to assess safety, tolerability, and preliminary efficacy for diabetic kidney disease.
Regular visits during treatment (visit frequency as per study schedule)
Duration - 4 weeks
Participants are monitored for safety and health outcomes after completing the treatment phase.
Visits for safety monitoring up to 40 weeks from start
Trial Site Locations
Total: 1 location
1
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
Research Team
R
Recruitment Contact
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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