| NCT ID | NCT07022418 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Medical University of South Carolina |
| Condition | Diabetic Nephropathies |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2025-12-01 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 120 participants in total. It began in 2025-12-01 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Joshua Lipschutz, MD
PRINCIPAL INVESTIGATOR
Medical University of South Carolina
Frequently Asked Questions
Who can join the NCT07022418 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Diabetic Nephropathies. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07022418 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07022418 currently recruiting?
Yes, NCT07022418 is actively recruiting participants. Contact the research team at recruitment@musc.edu for enrollment information.
Where is the NCT07022418 trial being conducted?
This trial is being conducted at Charleston, United States.
Who is sponsoring the NCT07022418 clinical trial?
NCT07022418 is sponsored by Medical University of South Carolina. The principal investigator is Joshua Lipschutz, MD at Medical University of South Carolina. The trial plans to enroll 120 participants.