The TRANQUILITY study is a clinical research study for people who have a diagnosis of chronic kidney disease (CKD) and high levels of a protein in their blood called high-sensitivity C-Reactive Protein (hs-CRP). Participants will have their hs-CRP tested if they decide to take part in the study.
The investigational study drug is named TOUR006, and it targets and inhibits the IL-6 (Interleukin 6) pathway. The hs-CRP protein is a marker for IL-6 driven inflammation. Studies suggest that IL-6 driven inflammation increases the risk of atherosclerotic cardiovascular disease (ASCVD), ASCVD is the disease process that causes heart attacks and the majority of strokes.
It is not known whether any drug that targets and inhibits IL-6 pathway will affect the risk of ASCVD. This Phase 2 study will not examine whether or not the study drug TOUR006 affects the risk of ASCVD. The goal of the study is to evaluate the safety and hs-CRP-lowering effect of quarterly and monthly TOUR006 and to compare TOUR006 with placebo.
Study participants may be able to join the study if they meet the following requirements:
Age ≥ 18 years
Confirmed diagnosis of chronic kidney disease CKD
No recent history of serious or chronic infections, have no immunocompromising conditions, and not taking medications that impair the immune system.
This is not a complete list of study eligibility requirements. The study doctor will review the full requirements for this study with you.
Participation in the TRANQUILITY study lasts approximately 12 months. Study participants can expect the following:
Participation in this study is voluntary. You can ask any questions you have and may leave the study at any time, for any reason.
Participants will receive all study-related procedures and the TOUR006 or placebo at no cost. You may be eligible for reasonable compensation for your time to attend study visits and/or reimbursement for certain approved study-related costs, such as transportation, lodging, and meals.
The investigational study drug is named TOUR006 and it targets and inhibits the IL-6 (Interleukin 6) pathway.
Investigational means the study medication is not approved by regulatory authorities like the US Food and Drug Administration (FDA), and it can only be used in clinical research studies like TRANQUILITY.
Participants will be chosen at random to receive either TOUR006 or a placebo. 75% of participants will receive TOUR006 and 25% of participants will receive placebo. A single dose of the assigned treatment will be given subcutaneously once a month, for 6 months.
Here are some common questions and answers about study participation.
Clinical research studies are designed to answer specific questions about the safety or effectiveness of investigational drugs, vaccines, other experimental approaches, or new ways of using existing treatments. Studies are important for medical advancement. Current treatments for diseases and conditions are only available because of study volunteers, and what we learn from the TRANQUILITY study could help accelerate the development of new therapies and inform future research, which may help patients with CKD and elevated hs-CRP in the future.
Before enrolling in a clinical trial, you must sign an Informed Consent Form (ICF). The ICF contains information about the study, including study goals, how long the study will last, benefits and risks, and the tests and procedures you will receive.
Study participation involves visiting a clinic regularly, taking or receiving an investigational drug, and having assessments to monitor your health. You can still see your regular doctor, but you should let them know that you are participating in a study.
Participation in clinical research studies is your choice, and you may stop at any time.
If you have additional questions about participating in a clinical trial, contact a study clinic near you.
Use the filters, map, and listing to find the study clinic closest to you. Contact the study clinic to learn more.