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Clinical Trial Details

Trial ID: L5249
Source ID: NCT04929379
Associated Drug: Fenofibrate
Title: A Pilot Study of Fenofibrate to Prevent Kidney Function Loss in Type 1 Diabetes
Acronym: PERL-FENO
Status: ACTIVE_NOT_RECRUITING
Study Results: NO
Results:
Conditions: Diabetic Nephropathies
Interventions: DRUG: Fenofibrate|OTHER: Placebo
Outcome Measures: Primary: Baseline-adjusted iGFR at 8 weeks after randomization, GFR measured by iohexol plasma disappearance (ml/min/1.73 m2), adjusted by its baseline value, 8 weeks after randomization|Baseline-adjusted iGFR at the end of the drug wash-out period, GFR measured by iohexol plasma disappearance (ml/min/1.73 m2), adjusted by its baseline value, 84 weeks after randomization|Baseline-adjusted levels of serum biomarkers of increased ESKD risk at the end of the drug wash-out period, Levels of the following 21 serum biomarkers, adjusted by their baseline values: CD160, CD27, DLL1, EDA2R, EFNA4, EPHA2, GFRA1, IL1RT1, KIM1, LAYN, LTBR, PI3, PVRL4, RELT, SYND1, TNFR1, TNFR2, TNFRSF10A, TNFRSF4, TNFRSF6B, WFDC2, 84 weeks after randomization | Secondary: Baseline-adjusted iGFR at the end of treatment, GFR measured by iohexol plasma disappearance (ml/min/1.73 m2), adjusted by its baseline value, 76 weeks after randomization|iGFR at the end of treatment, GFR measured by iohexol plasma disappearance (ml/min/1.73 m2), adjusted by its value at week 8, 76 weeks after randomization|Baseline-adjusted eGFR-SCr at 8 weeks after randomization, GFR estimated from serum creatinine (ml/min/1.73 m2) using the CKD-EPI equation, adjusted by its baseline value, 8 weeks after randomization|Baseline-adjusted eGFR-SCr at the end of treatment, GFR estimated from serum creatinine (ml/min/1.73 m2) using the CKD-EPI equation, adjusted by its baseline value, 76 weeks after randomization|eGFR-SCr at the end of treatment, GFR estimated from serum creatinine (ml/min/1.73 m2) using the CKD-EPI equation, adjusted by its value at week 8, 76 weeks after randomization|Baseline-adjusted eGFR-SCr at the end of the wash-out period, GFR estimated from serum creatinine (ml/min/1.73 m2) using the CKD-EPI equation, adjusted by its baseline value, 84 weeks after randomization|Baseline-adjusted eGFR-CysC at 8 weeks after randomization, GFR estimated from serum cystatin C (ml/min/1.73 m2) using the CKD-EPI equation, adjusted by its baseline value, 8 weeks after randomization|Baseline-adjusted eGFR-CysC at the end of treatment, GFR estimated from serum cystatin C (ml/min/1.73 m2) using the CKD-EPI equation, adjusted by its baseline value, 76 weeks after randomization|eGFR-CysC at the end of treatment, GFR estimated from serum cystatin C (ml/min/1.73 m2) using the CKD-EPI equation, adjusted by its value at week 8, 76 weeks after randomization|Baseline-adjusted eGFR-CysC at the end of the wash-out period, GFR estimated from serum cystatin C (ml/min/1.73 m2) using the CKD-EPI equation, adjusted by its baseline value, 84 weeks after randomization|Baseline-adjusted uAER at 8 weeks after randomization, Urinary Albumin excretion rate (uAER, mg/24/hr) based on overnight urine collection, adjusted by its baseline value, 8 weeks after randomization|Baseline-adjusted uAER at the end of treatment, Urinary albumin excretion rate (uAER, mg/24 hr) based on overnight urine collection, adjusted by its baseline value, 76 weeks after randomization|uAER at the end of treatment, Urinary Albumin excretion rate (uAER, mg/24 hr) based on overnight urine collection, adjusted by its value at week 8, 76 weeks after randomization|Baseline-adjusted uAER at the end of the wash-out period, Urinary albumin excretion rate (uAER, mg/24 hr) based on overnight urine collection, adjusted by its baseline value, 84 weeks after randomization|Baseline-adjusted creatinine clearance at 8 weeks after randomization, Creatinine clearance (ml/min) based on overnight urine collection, adjusted by its baseline value, 8 weeks after randomization|Baseline-adjusted ERPF at 8 weeks after randomization, Effective renal plasma flow (ml/min) measured by means of para-aminohippurate infusion, adjusted by its baseline value, 8 weeks after randomization|Baseline-adjusted afferent renal arteriolar resistance at 8 weeks after randomization, Afferent renal arteriolar resistance (dyne/s/cm5) measured by means of para-aminohippurate infusion, adjusted by its baseline value, 8 weeks after randomization|Baseline-adjusted efferent renal arteriolar resistance at 8 weeks after randomization, Efferent renal arteriolar resistance (dyne/s/cm5) measured by means of para-aminohippurate infusion, adjusted by its baseline value, 8 weeks after randomization|Baseline-adjusted glomerular hydrostatic pressure at 8 weeks after randomization, Glomerular hydrostatic pressure (mmHg) measured by means of para-aminohippurate infusion, adjusted by its baseline value, 8 weeks after randomization|Baseline-adjusted glomerular filtration pressure at 8 weeks after randomization, Glomerular filtration pressure (mmHg) measured by means of para-aminohippurate infusion, adjusted by its baseline value, 8 weeks after randomization|Baseline-adjusted glomerular oncotic pressure at 8 weeks after randomization, Glomerular oncotic pressure (mmHg) measured by means of para-aminohippurate infusion, adjusted by its baseline value, 8 weeks after randomization|eGFR-SCr trajectory, Trajectory of GFR estimated from serum creatinine (ml/min/year/1.73 m2) using the CKD-EPI equation, 8 to 76 weeks from randomization|eGFR-SCys trajectory, Trajectory of GFR estimated from serum cystatin C (ml/min/year/1.73 m2) using the CKD-EPI equation, 8 to 76 weeks from randomization|Baseline-adjusted levels of serum biomarkers of increased ESKD risk at the end of treatment, Levels of the following 21 serum biomarkers, adjusted by their baseline values: CD160, CD27, DLL1, EDA2R, EFNA4, EPHA2, GFRA1, IL1RT1, KIM1, LAYN, LTBR, PI3, PVRL4, RELT, SYND1, TNFR1, TNFR2, TNFRSF10A, TNFRSF4, TNFRSF6B, WFDC2, 76 weeks after randomization|Levels of serum biomarkers of increased ESKD risk at the end of treatment, Levels of the following 21 serum biomarkers, adjusted by their values at week 8: CD160, CD27, DLL1, EDA2R, EFNA4, EPHA2, GFRA1, IL1RT1, KIM1, LAYN, LTBR, PI3, PVRL4, RELT, SYND1, TNFR1, TNFR2, TNFRSF10A, TNFRSF4, TNFRSF6B, WFDC2, 76 weeks after randomization
Sponsor/Collaborators: Sponsor: Alessandro Doria | Collaborators: University of Michigan|University of Minnesota
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 40
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2022-01-04
Completion Date: 2025-08-01
Results First Posted:
Last Update Posted: 2024-12-02
Locations: Joslin Diabetes Center, Boston, Massachusetts, 02215, United States|Lahey Hospital and Medical center, Burlington, Massachusetts, 01805, United States|Brehm Center for Diabetes Research / University of Michigan, Ann Arbor, Michigan, 48105, United States|SUNY Upstate Medical University, Syracuse, New York, 13210, United States
URL: https://clinicaltrials.gov/show/NCT04929379