| Trial ID: | L0938 |
| Source ID: | NCT06072326
|
| Associated Drug: |
Sotagliflozin
|
| Title: |
Ambrisentan Sotagliflozin and Prevention of Renal Injury; a Randomized Evaluation
|
| Acronym: |
ASPIRE
|
| Status: |
NOT_YET_RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 1 Diabetes Mellitus With Diabetic Nephropathy
|
| Interventions: |
DRUG: Sotagliflozin|DRUG: Ambrisentan|DRUG: Ambrisentan and Sotagliflozin
|
| Outcome Measures: |
Primary: change from baseline in Urine Albumin-Creatinine Ratio (UACR), change from baseline in Urine Albumin-Creatinine Ratio (UACR) when treated with ambrisentan alone versus combination of sotagliflozin and ambrisentan., 4 weeks | Secondary: change from baseline in mGFR, Glomerular Filtration Rate (GFR) using iohexol clearance techniques., 4 weeks|Change in biomarkers of fluid retention, Change from baseline biomarkers of fluid retention (body weight, hemoglobin, N-terminal prohormone of Brain Natriuretic Peptide (NT-proBNP)), 4 weeks|Change in biomarkers of fluid retention, Change from baseline biomarkers of fluid retention (Body Weight), 4 weeks|Change in biomarkers of fluid retention, Change from baseline biomarkers of fluid retention (hemoglobin), 4 weeks|Change in biomarkers of fluid retention, Change from baseline biomarkers of fluid retention (N-terminal prohormone of Brain Natriuretic Peptide (NT-proBNP)), 4 weeks|Change from baseline Extracellular Volume (ECV), Extracellular volume (ECV) using iohexol clearance techniques and bioimpedance spectroscopy., 4 weeks|Change from baseline blood pressure, Change in blood pressure as measure in mmHg, 4 weeks
|
| Sponsor/Collaborators: |
Sponsor: University Medical Center Groningen | Collaborators: Juvenile Diabetes Research Foundation|Lexicon Pharmaceuticals
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
36
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2025-09
|
| Completion Date: |
2027-12
|
| Results First Posted: |
|
| Last Update Posted: |
2025-04-22
|
| Locations: |
University of Colorado, Anschutz Medical Center, Aurora, Colorado, 80045, United States|Institute de Recherches Cliniques de Montreal, Montréal, Quebec, H2W IR7, Canada|University of Toronto, Toronto, M5G 2N2, Canada|Steno Diabetes Center Copenhagen, Copenhagen, 2730 Herlev, Denmark|University of Helsinki, Helsinki, Uusimaa, 00029 HUS, Finland|Amsterdam University Academic Center, Amsterdam, Noord Holland, 1081 HV, Netherlands|University Medical Center Groningen, Groningen, 9700 RB, Netherlands
|
| URL: |
https://clinicaltrials.gov/show/NCT06072326
|
