Diabetic NephropathiesPhase 2NCT07022418
Formoterol in Diabetes
A Phase 2 study testing Formoterol furmarate (20 μg) in people with Diabetic Nephropathies and Diabetic Kidney Disease, run by Medical University of South Carolina at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetic Nephropathies, Diabetic Kidney Disease
- What is being tested?
- Formoterol furmarate (20 μg)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2025to Nov 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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.
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
Recruitment, 8437920965, recruitment@musc.edu
About this study
Official title: Prospective Randomized Pilot Trial of Formoterol in Patients With Diabetic Kidney Disease
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.
Read the detailed description
Glomerular function is highly dependent on specialized cells known as podocytes, which are critical components of glomeruli. Diseases affecting podocytes and the glomerulus, such as diabetes, are the leading causes of ESKD, and there are no specific therapies that restore injury-induced loss of podocyte structure and function. It was previously shown using mouse models of podocyte injury that formoterol fumarate, a long-acting β2-AR agonist given four hours following injury, when glomerular dysfunction is already established, restored glomerular structure, significantly reduced proteinuria, and accelerated recovery of glomerular function. To determine if a similar effect occurred in CKD, specifically DN, investigators used streptozotocin, a murine model of type 1 diabetes, and a high fat diet (HFD), a murine model of type 2 diabetes, to examine the role of formoterol fumarate in DN. Following formoterol fumarate treatment, there was a marked recovery from and reversal of DN in the streptozotocin and HFD mice treated with formoterol fumarate compared to those treated with vehicle alone at the ultrastructural, histological, and functional levels. Investigators also performed a competing risk regression in Veterans aged 65 or over with incident CKD stage 4 to compare the rate of ESKD progression in Veterans without and with COPD, who use β2-AR agonists. Investigators found a 25.6% reduction in the rate of ESKD in Veterans with COPD compared to those without4. In a second cohort of Veterans, Investigators demonstrated significantly slower progression from CKD stage 3 to CKD stage 5 in patients with COPD compared to those without COPD. Together these data indicate that β2-AR agonists, especially formoterol fumarate, may be a novel treatment for DN.
- Conditions
- Diabetic Nephropathies, Diabetic Kidney Disease
- Being tested
- Formoterol furmarate (20 μg)
- Keywords
- Diabetes
- Medical subject headings
- Diabetic Nephropathies, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Formoterol furmarate (20 μg)Drug
Investigators chose to use the long-acting β2-AR agonist, formoterol, because of its efficacy and safety profile in patients with COPD and because formoterol showed the most association with protection from progression of CKD in our retrospective study.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care Only | No intervention | Standard of Care Treatment Only |
| Formoterol Fumarate + Standard of Care Treatment | Experimental | Formoterol Fumarate Inhalation Solution as one 20 mcg unit-dose vial administered twice daily (morning and evening) by nebulization (in addition to standard of care treatment) Receives: Drug: Formoterol furmarate (20 μg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility: refusal rate and adherence during the 36-week treatment
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.
Measured: 36 weeks
To assess the safety, tolerability, and acceptability of the intervention with formoterol
Rates of adverse events and safety measures will be compared between groups. The investigators will assess adherence with the intervention and study medication.
Measured: 36 Weeks
To perform preliminary efficacy testing and determine the variability of albuminuria
Changes in albuminuria will be compared between groups to provide preliminary efficacy testing.
Measured: 36 Weeks
To perform preliminary efficacy testing and determine the variability of eGFR.
Changes in eGFR will be compared between groups to provide preliminary efficacy testing. eGFR will be assessed using the CKD-Epi Formula.
Measured: 36 Weeks
Secondary outcomes (14)
Safety Monitoring: Body Weight
Body weight will be measured using a digital scale accurate to +/- 0.1 kg at Screening, Week 0, Week 24, and Week 36. The investigator monitors changes in participants' body to detect any changes that may indicate treatment effects or safety concerns.
Measured: 36 Weeks
EKG Evaluations
An EKG will be performed at Screening, Week 0, Week 4, Week 16, Week 36, and Week 40. The investigators will be monitoring for new EKG changes suggestive of beta-adrenergic use such as flattening of the T wave, prolongation of the QTc interval, and ST segment depression, and/or serum potassium <3.0 mEQ/L refractory to medical therapy.
Measured: 40 Weeks
Adherence
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
Measured: 36 Weeks
Adverse Events
Rate of protocol related adverse events and serious adverse events will be compared between groups
Measured: 40 Weeks
Tolerability and acceptability
Intervention Tolerability: Participants will be asked every four weeks (Week 4-36) to rate on a 1-10 Likert scale how tolerable the intervention was over the past four weeks.
Intervention Acceptability: Satisfaction with the intervention will be assessed every 4 weeks (Week 4-36) with a questionnaire that asks participants to rate on a 1-10 Likert scale how satisfied they were with specific domains of the intervention over the past 4 weeks. The major domains that will be assessed are satisfaction with: 1) how hard was it to adhere to prescribed treatment, and 2) how likely they feel they can adhere to the prescribed treatment for the next four weeks. Participants will also be asked in open-ended fashion to provide feedback on each domain of the intervention. The investigators will also assess intervention acceptability by comparing the frequency of protocol related adverse events, requirement for protocol modification, and attrition between groups.
Measured: 32 Weeks
Liver Ultrasound Elastography
non-invasive liver ultrasound elastography to determine if the patients had an improvement in liver steatosis with formoterol
Measured: 36 Weeks
Laboratory Evaluations: HbA1c
HbA1c assessments at Screening, Week 0, Week 16, Week 36, and Week 40 will be estimated and compared between and within groups.
Measured: 40 Weeks
Laboratory Evaluations: CMP
Comprehensive Metabolic Panel (CMP) (including hypokalemia assessments) at Screening, Week 0, Week 4, Week 12, Week 24, Week 36, and Week 40 will be estimated and compared between and within groups.
Measured: 40 Weeks
Laboratory Evaluations: Urine Albumin
Change in albuminuria between groups from baseline to the end of the study
Measured: 40 Weeks
Laboratory Evaluations: eGFR
Change in estimated glomerular filtration rate (eGFR, CKD-Epi eGFR formula) between groups from baseline to the end of the study
Measured: 40 Weeks
Safety Monitoring: Heart Rate
The investigator monitors changes in participants' heart rate throughout the trial to detect any changes that may indicate treatment effects or safety concerns.
Measured: 40 Weeks
Safety Monitoring: Blood Pressure
The investigator monitors changes in participants' blood pressure throughout the trial to detect any changes that may indicate treatment effects or safety concerns. Blood pressure (BP) will be measured with a sphygmomanometer (average of 2 seated values taken after five minutes of rest).
Measured: 40 Weeks
Safety Monitoring: Respiratory Rate
The investigator monitors changes in participants' respiratory rate throughout the trial to detect any changes that may indicate treatment effects or safety concerns.
Measured: 40 Weeks
Safety Monitoring: Temperature
The investigator monitors changes in participants' temperature throughout the trial to detect any changes that may indicate treatment effects or safety concerns.
Measured: 40 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2025
- Study start1 Dec 2025
- Primary completionDec 2026 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic NephropathiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- Dialysis Clinic, Inc.
- Responsible party
- Principal investigator, Joshua Lipschutz, Medical University of South Carolina
- Investigators
- Joshua Lipschutz, MD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07022418
- Sponsor's protocol ID
- Pro00144030
- Status last verified
- Nov 2025
- First submitted
- 21 May 2025
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Pilot Trial of Formoterol in Patients With Diabetic Kidney Disease
- ClinicalTrials.gov ID
- NCT07022418
- Acronym / sponsor ID
- Pro00144030
- Conditions
- Diabetic Nephropathies, Diabetic Kidney Disease
- Keywords
- Diabetes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- Dialysis Clinic, Inc.
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 15 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Glomerular function is highly dependent on specialized cells known as podocytes, which are critical components of glomeruli. Diseases affecting podocytes and the glomerulus, such as diabetes, are the leading causes of ESKD, and there are no specific therapies that restore injury-induced loss of podocyte structure and function. It was previously shown using mouse models of podocyte injury that formoterol fumarate, a long-acting β2-AR agonist given four hours following injury, when glomerular dysfunction is already established, restored glomerular structure, significantly reduced proteinuria, and accelerated recovery of glomerular function. To determine if a similar effect occurred in CKD, specifically DN, investigators used streptozotocin, a murine model of type 1 diabetes, and a high fat diet (HFD), a murine model of type 2 diabetes, to examine the role of formoterol fumarate in DN. Following formoterol fumarate treatment, there was a marked recovery from and reversal of DN in the streptozotocin and HFD mice treated with formoterol fumarate compared to those treated with vehicle alone at the ultrastructural, histological, and functional levels. Investigators also performed a competing risk regression in Veterans aged 65 or over with incident CKD stage 4 to compare the rate of ESKD progression in Veterans without and with COPD, who use β2-AR agonists. Investigators found a 25.6% reduction in the rate of ESKD in Veterans with COPD compared to those without4. In a second cohort of Veterans, Investigators demonstrated significantly slower progression from CKD stage 3 to CKD stage 5 in patients with COPD compared to those without COPD. Together these data indicate that β2-AR agonists, especially formoterol fumarate, may be a novel treatment for DN.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care Only | No intervention | –Standard of Care Treatment Only |
| Formoterol Fumarate + Standard of Care Treatment | Experimental | Drug: Formoterol furmarate (20 μg)Formoterol Fumarate Inhalation Solution as one 20 mcg unit-dose vial administered twice daily (morning and evening) by nebulization (in addition to standard of care treatment) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Formoterol furmarate (20 μg)Investigators chose to use the long-acting β2-AR agonist, formoterol, because of its efficacy and safety profile in patients with COPD and because formoterol showed the most association with protection from progression of CKD in our retrospective study. | Drug | Formoterol Fumarate + Standard of Care Treatment |
Primary outcome
Feasibility: refusal rate and adherence during the 36-week treatment
Time frame: 36 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 formoterol
Time frame: 36 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 albuminuria
Time frame: 36 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.
Time frame: 36 Weeks
Changes in eGFR will be compared between groups to provide preliminary efficacy testing. eGFR will be assessed using the CKD-Epi Formula.
14 secondary outcomes
Safety Monitoring: Body Weight
Time frame: 36 Weeks
EKG Evaluations
Time frame: 40 Weeks
Adherence
Time frame: 36 Weeks
Adverse Events
Time frame: 40 Weeks
Tolerability and acceptability
Time frame: 32 Weeks
Liver Ultrasound Elastography
Time frame: 36 Weeks
Laboratory Evaluations: HbA1c
Time frame: 40 Weeks
Laboratory Evaluations: CMP
Time frame: 40 Weeks
Laboratory Evaluations: Urine Albumin
Time frame: 40 Weeks
Laboratory Evaluations: eGFR
Time frame: 40 Weeks
Safety Monitoring: Heart Rate
Time frame: 40 Weeks
Safety Monitoring: Blood Pressure
Time frame: 40 Weeks
Safety Monitoring: Respiratory Rate
Time frame: 40 Weeks
Safety Monitoring: Temperature
Time frame: 40 Weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
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Diabetic Nephropathies MeSH:D003928, Diabetes Mellitus, Type 2
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Joshua Lipschutz, MD principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Formoterol furmarate (20 μg) in people with Diabetic Nephropathies and Diabetic Kidney Disease, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Recruitment Contact ((843) 792-0965, recruitment@musc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility: refusal rate and adherence during the 36-week treatment (time frame: 36 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.