Pilot Study of Formoterol Inhalation Added to Standard Treatment for Adults with Diabetic Kidney Disease Aged 18 to 75

What this Trial Is About

Researchers are evaluating the potential of formoterol fumarate in treating patients with diabetic kidney disease. This phase 2 randomized trial aims to assess the feasibility, safety, and preliminary effectiveness of adding formoterol fumarate to the standard care for diabetic nephropathy. The study builds on promising preclinical and retrospective data suggesting formoterol may help restore kidney function and slow disease progression in diabetes-related kidney damage. Participants will be randomly assigned to one of two groups one group will receive formoterol fumarate inhalation solution twice daily via nebulization along with their usual standard of care treatment, while the other group will continue with standard of care treatment only. This treatment phase lasts 36 weeks. The trial also includes safety monitoring and assessments up to 40 weeks. Throughout the study, participants will undergo various evaluations including laboratory tests for kidney function eGFR and urine albumin, blood sugar HbA1c, and heart monitoring EKG, blood pressure, heart rate. Researchers will track adherence, tolerability, safety, and changes in kidney function to understand the treatments impact. The total study duration includes treatment and follow-up assessments over approximately 40 weeks.

Formoterol in Diabetes