Formoterol for diabetic kidney disease
Prospective Randomized Pilot Trial of Formoterol in Patients With Diabetic Kidney Disease
This trial will test whether adding formoterol fumarate to usual care helps adults with type 2 diabetes who have moderate diabetic kidney disease.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Medical University of South Carolina Academic / other |
| Locations | 1 site (Charleston, South Carolina) |
| Trial ID | NCT07022418 on ClinicalTrials.gov |
What this trial studies
This Phase 2, randomized study assigns participants to receive either formoterol fumarate (20 µg) in addition to their standard care or to continue standard care alone, with roughly a 50/50 split. The trial targets adults with type 2 diabetes and CKD stages G2–G3b with elevated albuminuria, and requires stable background diabetes and blood pressure therapies. The primary purpose is to gather feasibility data and estimate effect sizes to power a larger definitive trial. The rationale includes preclinical mouse models showing reversal of diabetic nephropathy after formoterol and observational cohort data suggesting lower ESKD rates among users of β2-AR agonists.
Who should consider this trial
Good fit: Adults 18–75 with type 2 diabetes, CKD G2–G3b and albuminuria (UACR 200–5000 mg/g), HbA1c <8%, and on stable background therapy (including ACE inhibitor/ARB and/or SGLT2 inhibitor when appropriate) are the intended participants.
Not a fit: People with more advanced kidney failure (stage 4–5 or on dialysis), non-diabetic kidney disease, poorly controlled diabetes (HbA1c ≥8%), unstable medication regimens, or other contraindications to β2-agonists are unlikely to benefit or are ineligible.
Why it matters
Potential benefit: If successful, adding formoterol could slow or partially reverse kidney damage in people with diabetic kidney disease and reduce progression to end-stage kidney disease.
How similar studies have performed: Preclinical mouse studies showed marked recovery of diabetic nephropathy with formoterol and an observational Veterans cohort found lower ESKD rates with β2-AR agonist use, but randomized human trials of this approach are currently limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Charleston, South Carolina
- Medical University of South Carolina — Charleston, South Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Joshua Lipschutz, MD — Medical University of South Carolina
- Study coordinator: Recruitment Contact
- Email: recruitment@musc.edu
- Phone: (843) 792-0965
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.