Health TrialsbyHealthPanel

Formoterol in Diabetes

ConditionsDiabetic NephropathiesDiabetic Kidney Disease
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorMedical University of South Carolina

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Standard of Care OnlyNo intervention 0 interventions
Group B: Formoterol Fumarate + Standard of Care TreatmentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
36 weeks
2

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.

Time frame
36 Weeks
3

To perform preliminary efficacy testing and determine the variability of albuminuria

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

Time frame
36 Weeks
4

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.

Time frame
36 Weeks

Secondary outcomes

1

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.

Time frame
36 Weeks
2

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.

Time frame
40 Weeks
3

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

Time frame
36 Weeks
4

Adverse Events

Rate of protocol related adverse events and serious adverse events will be compared between groups

Time frame
40 Weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Medical University of South Carolina

Lead sponsor

Dialysis Clinic, Inc.

Collaborator

Source ClinicalTrials.gov
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