A Study to Evaluate TOUR006 in Patients With Chronic Kidney Disease and Elevated Hs-CRP
Completed · Phase 2 · Has a placebo group
Conditions studied: 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
In brief
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.
Key facts
- Study ID
- NCT06362759
- Run by
- Tourmaline Bio, Inc., a Novartis Company
- People needed
- 143
- Starts
- 2024-05-15
- Expected to finish
- 2025-12-04
- Last updated by the study team
- 2026-02-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- 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
Full record on ClinicalTrials.gov
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