Back to search results

Formoterol for Diabetic Kidney Disease

This study is looking into whether formoterol fumarate, a medication already used for lung conditions, can help people with diabetic kidney disease. Researchers chose formoterol because past studies in animals and a review of patient data suggested it might protect the kidneys. You might be able to join if you are 18-75 years old, have type 2 diabetes, and have moderate diabetic kidney disease (CKD G2 to G3b; A2-A3 with a specific range for urinary albumin to creatinine excretion rate, UACR). The main goals are to see if the study is practical to run, if formoterol is safe and well-tolerated, and to get early information on how well it works to reduce protein in the urine (albuminuria). This information will help plan a larger study in the future. The study is currently unclear on its status and aims to enroll 120 participants.

Study design
This is an interventional study where participants will be randomly assigned to either receive formoterol fumarate or standard care, with a 50% chance of being in either group. Both groups will continue their usual medical treatments.
What's involved
Participants will receive treatment for 36 weeks. The study will assess refusal rates, adherence, safety, tolerability, acceptability, and albuminuria during this time.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoints are measured at 36 weeks, indicating participants will be followed for at least this duration.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07022418

Formoterol in Diabetes

Recruiting
PHASE2Ages 18–75InterventionalTreatment
Medical University of South Carolina
~120 participants
Updated 2026-02-05 on ClinicalTrials.gov
What's tested:Formoterol furmarate (20 μg)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Feasibility: refusal rate and adherence during the 36-week treatment
Measured over 36 weeks
+3 more outcomes measured

Conditions

Diabetic Nephropathies
Diabetic Kidney Disease

Explore related trials

Diabetes MellitusDiabetic Nephropathy

Where it's being run

1 sites across 1 states
South Carolina1

Study leadership

  • Joshua Lipschutz, MD · PRINCIPAL_INVESTIGATOR · Medical University of South Carolina

Who to contact

Recruitment Contact
[email protected]
(843) 792-0965
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

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

What this trial measures

  • Feasibility: refusal rate and adherence during the 36-week treatment36 weeks

    The primary measures of feasibility will be study refusal rate and adherence during the 36-week treatment. Refusal rate will be the percentage of individuals who are offered the opportunity to enroll but choose not to accept it. Adherence will be defined as the proportion of doses taken during the 36-week treatment period. For patients who fail to complete the study, adherence will be estimated as the number of doses they report taking for visits at which they are present over the total number of doses they should have received.

  • To assess the safety, tolerability, and acceptability of the intervention with formoterol36 Weeks

    Rates of adverse events and safety measures will be compared between groups. The investigators will assess adherence with the intervention and study medication.

  • To perform preliminary efficacy testing and determine the variability of albuminuria36 Weeks

    Changes in albuminuria will be compared between groups to provide preliminary efficacy testing.

  • To perform preliminary efficacy testing and determine the variability of eGFR.36 Weeks

    Changes in eGFR will be compared between groups to provide preliminary efficacy testing. eGFR will be assessed using the CKD-Epi Formula.