A Study to Evaluate TOUR006 in Patients With Chronic Kidney Disease and Elevated Hs-CRP
NCT ID: NCT06362759
Last Updated: 2025-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
PHASE2
143 participants
INTERVENTIONAL
2024-05-15
2025-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
TOUR006 - 50 MG
50 mg administered subcutaneously at Day 1 and Day 90 (Placebo administered at 30, 60, 120, and 150 Day timepoints)
TOUR006 - 50 MG
TOUR006 50 MG
TOUR006 - 25 MG
25 mg administered subcutaneously at Day 1 and Day 90 (Placebo administered at 30, 60, 120, and 150 Day timepoints)
TOUR006 - 25 MG
TOUR006 25 MG
TOUR006 - 15 MG
15 mg administered subcutaneously at Days 1, 30, 60, 90, 120, and 150
TOUR006 - 15 MG
TOUR006 15 MG
Placebo
Administered subcutaneously at Days 1, 30, 60, 90, 120, and 150
Placebo
Placebo
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
TOUR006 - 50 MG
TOUR006 50 MG
TOUR006 - 25 MG
TOUR006 25 MG
TOUR006 - 15 MG
TOUR006 15 MG
Placebo
Placebo
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Serum hs-CRP level ≥2.0 mg/L and \<15 mg/L
* Diagnosis of chronic kidney disease, eGFR ≥15 and \<60 mL/min/1.73 m2 or eGFR ≥60 mL/min/1.73m2 and UPCR\>200 mg/g
* Received COVID-19 vaccine at least 30 days prior to the Screening visit, per participant verbal attestation.
* Agreement to comply with contraception and reproduction restrictions
Exclusion Criteria
* Current or recent COVID-19 infection within 30 days
* Serious infection within 6 months or more than 1 such episode within 18 months
* Any history of a serious opportunistic infection within 18 months
* Known history of immunodeficiency
* History of gastrointestinal ulceration or perforation within 12 months
* History of active diverticulitis, active inflammatory bowel disease, or GI abscess within 12 months
* History of GI bleeding requiring hospitalization and/or transfusion within 6 months
* New York Heart Association Class III or IV congestive heart failure and/or hospitalization for heart failure exacerbation within 6 months
* Acute coronary syndrome, stroke, transient ischemic attack, or other thrombotic or thromboembolic event, or arterial revascularization procedure within 6 months
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Tourmaline Bio, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Clinical Trials
Role: STUDY_DIRECTOR
Tourmaline Bio
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Site - 0101
Birmingham, Alabama, United States
Site - 0135
Huntsville, Alabama, United States
Site - 0145
Huntsville, Alabama, United States
Site - 0104
Phoenix, Arizona, United States
Site - 0125
San Dimas, California, United States
Site - 0112
Valencia, California, United States
Site - 0128
Valencia, California, United States
Site - 0136
Stamford, Connecticut, United States
Site - 0113
Greenacres City, Florida, United States
Site - 0149
Pembroke Pines, Florida, United States
Site - 0144
Plantation, Florida, United States
Site - 0119
Port Orange, Florida, United States
Site - 0151
Tampa, Florida, United States
Site - 0122
Savannah, Georgia, United States
Site - 0106
Chicago, Illinois, United States
Site - 0115
Morton, Illinois, United States
Site - 0114
Council Bluffs, Iowa, United States
Site - 0129
Metairie, Louisiana, United States
Site - 0123
Las Vegas, Nevada, United States
Site - 0130
Middletown, New York, United States
Site - 0110
Charlotte, North Carolina, United States
Site - 0117
Fargo, North Dakota, United States
Site - 0120
Cincinnati, Ohio, United States
Site - 0127
Marion, Ohio, United States
Site - 0132
Bethlehem, Pennsylvania, United States
Site - 0126
Providence, Rhode Island, United States
Site - 0102
Fort Mill, South Carolina, United States
Site - 0103
Greenville, South Carolina, United States
Site - 0108
Knoxville, Tennessee, United States
Site - 0148
Greenville, Texas, United States
Site - 0105
Houston, Texas, United States
Site - 0111
Lampasas, Texas, United States
Site - 0150
McKinney, Texas, United States
Site - 0107
San Antonio, Texas, United States
Site - 0141
San Antonio, Texas, United States
Site - 0109
Manassas, Virginia, United States
Site - 0147
Morgantown, West Virginia, United States
Site - 0134
Kenosha, Wisconsin, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
TOUR006-C01
Identifier Type: -
Identifier Source: org_study_id