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Clinical Trial Details

Trial ID: L1438
Source ID: NCT05285878
Associated Drug: Fingolimod
Title: Fingolimod for the Abrogation of Interstitial Fibrosis and Tubular Atrophy Following Kidney Transplantation
Acronym:
Status: ENROLLING_BY_INVITATION
Study Results: NO
Results:
Conditions: Interstitial Fibrosis|Kidney Transplant; Complications|Kidney Transplant Rejection|Kidney Transplant Failure and Rejection|Kidney Transplant Failure|Kidney Failure, Chronic|Graft Rejection
Interventions: DRUG: Fingolimod|DRUG: Placebo
Outcome Measures: Primary: Emergent and Adverse Events, The difference in the proportion of cumulative treatment-emergent (TE) adverse events (AE) determined to be ≥ grade 3 severity that occur during 12 months from the first dose of FTY720 compared to the placebo group., Baseline (day of kidney transplant surgery); 3, 14, 30, 90, 180, 270, and 365 days after starting study drug or placebo | Secondary: Fraction of Renal Cortical Volume Occupied by Interstitium, A doubling of the fraction of renal cortical volume occupied by interstitium (VvInt/cortex) compared to the baseline biopsy in participants taking 0.5mg/day fingolimod (experimental group) or placebo (control group) for 3 months, Baseline, 3 months after kidney transplant, 1 year after kidney transplant|MCP1 Biomarker, Measurement of Monocyte Chemoattractant Protein-1, Baseline, 90 days, and 1 year after the first dose of fingolimod or placebo|Procollagen 3 Peptide Biomarker, Measurement of Procollagen 3 Peptide, Baseline, 90 days, and 1 year after the first dose of fingolimod or placebo|BMP-7 Protein Biomarker, Measurement of Bone Morphogenetic Protein 7, Baseline, 90 days, and 1 year after the first dose of fingolimod or placebo|TGF-beta Biomarker, Measurement of Transforming Growth Factor beta, Baseline, 90 days, and 1 year after the first dose of fingolimod or placebo|RhoA of Blood Monocytes, Measurement of Ras homolog family member A protein, Baseline, 90 days, and 1 year after the first dose of fingolimod or placebo|RICTOR Biomarker, Measurement of RPTOR Independent Companion Of MTOR Complex 2, Baseline, 90 days, and 1 year after the first dose of fingolimod or placebo|Urinary Albumin:Creatinine Ratio, The ratio of albumin to creatinine in a urine sample from the patient, Baseline; 3, 14, 30, 90, 180, 270, and 365 days after starting study drug or placebo|Change in Estimated Glomerular Filtration Rate, Estimated glomerular filtration rate relative to the baseline value or previous endpoints, Baseline; 3, 14, 30, 90, 180, 270, and 365 days after starting study drug or placebo|Causes of End-Stage Renal Disease, Recording the cause of end-stage renal disease, if it develops, Up to 1 year after taking the first dose of the study drug or placebo|Biopsy-Proven Acute Rejection, Biopsy-proven acute rejection as diagnosed by a qualified pathologist, Baseline, 3 months after kidney transplant, 1 year after kidney transplant|Patient Survival, Whether the patient is deceased or alive, Baseline; 3, 14, 30, 90, 180, 270, and 365 days after starting study drug or placebo|Graft Survival, Whether the patient required a new kidney graft or the patient is deceased, Baseline; 3, 14, 30, 90, 180, 270, and 365 days after starting study drug or placebo
Sponsor/Collaborators: Sponsor: The Methodist Hospital Research Institute
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 20
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, CARE_PROVIDER)|Primary Purpose: TREATMENT
Start Date: 2022-07-28
Completion Date: 2027-12
Results First Posted:
Last Update Posted: 2025-03-14
Locations: Houston Methodist Research Institute, Houston, Texas, 77030, United States
URL: https://clinicaltrials.gov/show/NCT05285878