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Anti-inflammatory
TOUR006 for Chronic Kidney Disease (TRANQUILITY Trial)
Phase 2
Recruiting
Research Sponsored by Tourmaline Bio, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age ≥18 years at time of ICF signature
Diagnosis of chronic kidney disease, eGFR ≥15 and <60 mL/min/1.73 m2
Must not have
History of gastrointestinal ulceration or perforation
History of active diverticulitis, active inflammatory bowel disease, or GI abscess within 12 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 365 days
Summary
This trial will look at how safe and well-tolerated a new drug is when given as a shot under the skin every three months or every month to people with chronic kidney disease and high levels of
Who is the study for?
This trial is for adults over 18 with chronic kidney disease who have an eGFR between ≥15 and <60 mL/min/1.73 m2 and elevated hs-CRP levels (≥2.0 mg/L but <15 mg/L). Participants must have received a COVID-19 vaccine at least 30 days prior to screening and agree to follow contraception guidelines.
What is being tested?
The study tests TOUR006 at different doses (25 MG, 50 MG, and 15 MG) versus a placebo in patients with chronic kidney disease. It aims to assess the drug's safety, how well it's tolerated, its pharmacokinetics (how it moves through the body), and its ability to lower CRP when given quarterly or monthly by injection.
What are the potential side effects?
While specific side effects of TOUR006 are not listed here, common ones may include reactions at the injection site, potential allergic responses, changes in blood markers related to kidney function or inflammation levels.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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My kidney function is reduced but not severely.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had stomach ulcers or tears in my stomach/intestines.
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I haven't had diverticulitis, inflammatory bowel disease, or a GI abscess in the last year.
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I might have an active infection.
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I haven't had a serious infection in the last year.
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I have had a serious infection due to a weak immune system.
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I have severe heart failure or was hospitalized for it in the last 6 months.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 365 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~365 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Evaluate the effects of TOUR006 compared with placebo on hs-CRP
Secondary study objectives
Evaluate the pharmacokinetics by measuring serum concentrations of TOUR006
Evaluate the safety and tolerability of TOUR006 in participants with elevated cardiovascular risk and CKD
Trial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: TOUR006 - 50 MGExperimental Treatment1 Intervention
50 mg administered subcutaneously at Day 1 and Day 90 (Placebo administered at 30, 60, 120, and 150 Day timepoints)
Group II: TOUR006 - 25 MGExperimental Treatment1 Intervention
25 mg administered subcutaneously at Day 1 and Day 90 (Placebo administered at 30, 60, 120, and 150 Day timepoints)
Group III: TOUR006 - 15 MGExperimental Treatment1 Intervention
15 mg administered subcutaneously at Days 1, 30, 60, 90, 120, and 150
Group IV: PlaceboPlacebo Group1 Intervention
Administered subcutaneously at Days 1, 30, 60, 90, 120, and 150
Find a Location
Who is running the clinical trial?
Tourmaline Bio, Inc.Lead Sponsor
1 Previous Clinical Trials
81 Total Patients Enrolled
Clinical TrialsStudy DirectorTourmaline Bio
2,233 Previous Clinical Trials
902,153 Total Patients Enrolled