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Clinical Trial Details

Trial ID: L0600
Source ID: NCT06362759
Associated Drug: Tour006 - 50 Mg
Title: A Study to Evaluate TOUR006 in Patients With Chronic Kidney Disease and Elevated Hs-CRP
Acronym: TRANQUILITY
Status: ACTIVE_NOT_RECRUITING
Study Results: NO
Results:
Conditions: Chronic Kidney Diseases|Chronic Kidney Insufficiency|Chronic Renal Diseases|Chronic Renal Insufficiency|Kidney Insufficiency, Chronic|C-Reactive Protein|High Sensitivity C-Reactive Protein|Hs-CRP|hsCRP
Interventions: DRUG: TOUR006 - 50 MG|DRUG: TOUR006 - 25 MG|DRUG: TOUR006 - 15 MG|OTHER: Placebo
Outcome Measures: Primary: Evaluate the effects of TOUR006 compared with placebo on hs-CRP, Evaluates the change from baseline in hs-CRP comparing TOUR006 and placebo, 90 days | Secondary: Evaluate the effects of TOUR006 compared with placebo on hs-CRP, Evaluates the change from baseline in hs-CRP comparing TOUR006 and placebo, 180 days|Evaluate the pharmacokinetics by measuring serum concentrations of TOUR006, Evaluates the serum concentrations of TOUR006 over time, Baseline through Day 365|Evaluate the safety and tolerability of TOUR006 in participants with elevated cardiovascular risk and CKD, Evaluates the percentage of participants with treatment emergent adverse events and serious adverse events, 365 days
Sponsor/Collaborators: Sponsor: Tourmaline Bio, Inc.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 143
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-05-15
Completion Date: 2025-12
Results First Posted:
Last Update Posted: 2025-01-10
Locations: Site - 0124, Birmingham, Alabama, 35205, United States|Site - 0101, Birmingham, Alabama, 35209, United States|Site - 0135, Huntsville, Alabama, 35763, United States|Site - 0145, Huntsville, Alabama, 35805, United States|Site - 0104, Phoenix, Arizona, 85018, United States|Site - 0125, San Dimas, California, 91773, United States|Site - 0112, Valencia, California, 91355, United States|Site - 0128, Valencia, California, 91355, United States|Site - 0136, Stamford, Connecticut, 06905, United States|Site - 0142, Boca Raton, Florida, 33434, United States|Site - 0113, Greenacres City, Florida, 334667, United States|Site - 0149, Pembroke Pines, Florida, 33024, United States|Site - 0144, Plantation, Florida, 33317, United States|Site - 0119, Port Orange, Florida, 32127, United States|Site - 0151, Tampa, Florida, 33634, United States|Site - 0122, Savannah, Georgia, 31406, United States|Site - 0139, Boise, Idaho, 83706, United States|Site - 0106, Chicago, Illinois, 60655, United States|Site - 0115, Morton, Illinois, 61550, United States|Site - 0133, Park Ridge, Illinois, 60068, United States|Site - 0114, Council Bluffs, Iowa, 51501, United States|Site - 0129, Metairie, Louisiana, 70006, United States|Site - 0140, Saint Clair Shores, Michigan, 48081, United States|Site - 0123, Las Vegas, Nevada, 89121, United States|Site - 0130, Middletown, New York, 10940, United States|Site - 0110, Charlotte, North Carolina, 28208, United States|Site - 0117, Fargo, North Dakota, 58104, United States|Site - 0120, Cincinnati, Ohio, 45219, United States|Site - 0127, Marion, Ohio, 43302, United States|Site - 0132, Bethlehem, Pennsylvania, 18017, United States|Site - 0138, Scottdale, Pennsylvania, 15683, United States|Site - 0126, Providence, Rhode Island, 02818, United States|Site - 0102, Fort Mill, South Carolina, 29707, United States|Site - 0103, Greenville, South Carolina, 29607, United States|Site - 0118, Rock Hill, South Carolina, 29732, United States|Site - 0116, Rapid City, South Dakota, 57702, United States|Site - 0143, Knoxville, Tennessee, 37909, United States|Site - 0108, Knoxville, Tennessee, 37923, United States|Site - 0148, Greenville, Texas, 75402, United States|Site - 0105, Houston, Texas, 77043, United States|Site - 0111, Lampasas, Texas, 76550, United States|Site - 0150, McKinney, Texas, 75069, United States|Site - 0107, San Antonio, Texas, 78212, United States|Site - 0141, San Antonio, Texas, 78255, United States|Site - 0109, Manassas, Virginia, 20110, United States|Site - 0137, Kingwood, West Virginia, 26537, United States|Site - 0147, Morgantown, West Virginia, 26505, United States|Site - 0134, Kenosha, Wisconsin, 53144, United States|Site - 0121, Wauwatosa, Wisconsin, 53226, United States
URL: https://clinicaltrials.gov/show/NCT06362759

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress