Formoterol for diabetic kidney disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Effects of low oxygen levels on kidney function in healthy individuals and diabetes patients

  This study is testing how low oxygen levels affect kidney function in healthy people and those with diabetes to see if there are different risks for kidney health.

  Recruiting Poitiers University Hospital · Poitiers · NCT06846034

• Understanding Diabetic Kidney Disease in Patients with Type 2 Diabetes

  This study is trying to understand how kidney disease affects people with Type 2 diabetes and macroalbuminuria by looking at their kidney samples and other health markers over 20 years to improve treatment options.

  Recruiting at 13 sites Herlev Hospital · Skejby, Aarhus and 12 other locations · NCT04916132

• MTX-439 safety test in healthy adults and adults with diabetic kidney disease

  This phase 1 study tests MTX-439 in healthy adults and adults with diabetic kidney disease to see if it is safe and how the body handles it.

  Recruiting Phase 1 Mediar Therapeutics · Melbourne, Victoria · NCT07473323

• Transformative 2.0 for diabetic kidney disease

  This project will try to see if adults with diabetic kidney disease who take SGLT2 diabetes medicines have different biological patterns in archived kidney tissue than similar people who do not take these medicines.

  Recruiting University of Pennsylvania · Philadelphia, Pennsylvania · NCT07444203

• ACE Reno Pico Cell Matrix for reducing proteinuria and supporting kidney function

  This trial will test whether taking ACE Reno, a sublingual peptide solution four times daily for 12 weeks, can lower urine protein and help stabilize kidney function in adults with nephropathy or chronic kidney disease.

  Recruiting Phase 4 Ace Cells Lab Limited · Giza, GZ · NCT07187713

• Pharmacist prescribing to improve kidney care for people with type 2 diabetes

  This project will test whether pharmacist prescribing guided by step-by-step algorithms helps adults with type 2 diabetes and early diabetic kidney disease who lack a regular doctor start recommended kidney‑protecting medications.

  Recruiting Nova Scotia Health Authority · Halifax, Nova Scotia · NCT07169422

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.