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A Study to Evaluate TOUR006 in Patients With Chronic Kidney Disease and Elevated Hs-CRP

CompletedPhase 2

Sponsor: Tourmaline Bio, Inc., a Novartis Company

Conditions: Chronic Kidney Diseases, Chronic Kidney Insufficiency, Chronic Renal Diseases, Chronic Renal Insufficiency, Kidney Insufficiency, Chronic

Interventions: TOUR006 - 50 MG, TOUR006 - 25 MG, TOUR006 - 15 MG, Placebo

Countries: United States

This study will evaluate the safety, tolerability, pharmacokinetics, and CRP-lowering effect of quarterly and monthly subcutaneous administration of TOUR006 (also known as pacibekitug) in participants with chronic kidney disease and elevated hs-CRP.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Age ≥18 years at time of ICF signature.
* 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:

* Clinical evidence or suspicion of active infection
* 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

Locations (38)

Birmingham, Alabama, United States
Huntsville, Alabama, United States
Huntsville, Alabama, United States
Phoenix, Arizona, United States
San Dimas, California, United States
Valencia, California, United States
Valencia, California, United States
Stamford, Connecticut, United States
Greenacres City, Florida, United States
Pembroke Pines, Florida, United States
Plantation, Florida, United States
Port Orange, Florida, United States
Tampa, Florida, United States
Savannah, Georgia, United States
Chicago, Illinois, United States
Morton, Illinois, United States
Council Bluffs, Iowa, United States
Metairie, Louisiana, United States
Las Vegas, Nevada, United States
Middletown, New York, United States
Charlotte, North Carolina, United States
Fargo, North Dakota, United States
Cincinnati, Ohio, United States
Marion, Ohio, United States
Bethlehem, Pennsylvania, United States
Providence, Rhode Island, United States
Fort Mill, South Carolina, United States
Greenville, South Carolina, United States
Knoxville, Tennessee, United States
Greenville, Texas, United States
+ 8 more on CT.gov