BridgeMD
New treatment option for Diabetic Nephropathies
Official title Formoterol in Diabetes
ClinicalTrials.gov ID: NCT07022418
What this study is testing
What is Formoterol furmarate (20 μg)?
Formoterol furmarate (20 μg) is an investigational medicine, being studied as a potential treatment for diabetic nephropathies.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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
You likely can't join if
- Female people 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...
- Any history of asthma
- Patients with serum potassium levels \<3.5 mEQ/L
See the full eligibility 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...
- Willing and able to comply with schedule of events and protocol requirements, including written informed consent.
- Female people 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 treatment study
- Unable or unwilling to do the 36-week intervention
The study team makes the final eligibility decision.
Where it's taking place
- Charleston, South Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Charleston, South Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.