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NCT06362759CompletedPhase 2

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

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Quarterly and Monthly TOUR006 in Participants With Chronic Kidney Disease and Elevated High-Sensitivity C-Reactive Protein

Source: ClinicalTrials.gov · Last updated 11 Aug 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
143 (actual)
First submitted
27 Mar 2024
Start date
15 May 2024
Primary completion date
6 Mar 2025
Lead sponsor
Tourmaline Bio, Inc., a Novartis Company
NCT number
NCT06362759

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 143
  • From 15 May 2024 to the primary completion date, 6 Mar 2025
  • 38 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (38)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
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BethlehemUnited StatesUnknown status
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BirminghamUnited StatesUnknown status
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CharlotteUnited StatesUnknown status
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ChicagoUnited StatesUnknown status
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CincinnatiUnited StatesUnknown status
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Council BluffsUnited StatesUnknown status
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FargoUnited StatesUnknown status
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Fort MillUnited StatesUnknown status
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Greenacres CityUnited StatesUnknown status
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GreenvilleUnited StatesUnknown status
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GreenvilleUnited StatesUnknown status
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HoustonUnited StatesUnknown status
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HuntsvilleUnited StatesUnknown status
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HuntsvilleUnited StatesUnknown status
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KenoshaUnited StatesUnknown status
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KnoxvilleUnited StatesUnknown status
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LampasasUnited StatesUnknown status
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Las VegasUnited StatesUnknown status
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ManassasUnited StatesUnknown status
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MarionUnited StatesUnknown status
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McKinneyUnited StatesUnknown status
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MetairieUnited StatesUnknown status
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MiddletownUnited StatesUnknown status
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MorgantownUnited StatesUnknown status
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MortonUnited StatesUnknown status
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Pembroke PinesUnited StatesUnknown status
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PhoenixUnited StatesUnknown status
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PlantationUnited StatesUnknown status
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Port OrangeUnited StatesUnknown status
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ProvidenceUnited StatesUnknown status
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San AntonioUnited StatesUnknown status
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San AntonioUnited StatesUnknown status
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San DimasUnited StatesUnknown status
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SavannahUnited StatesUnknown status
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StamfordUnited StatesUnknown status
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TampaUnited StatesUnknown status
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ValenciaUnited StatesUnknown status
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ValenciaUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.