Are you living with Chronic Kidney Disease (CKD)?

If so, consider joining the TRANQUILITY study, a clinical trial for people with Chronic Kidney Disease.

Study Overview

Are you living with Chronic Kidney Disease (CKD)?

If so, consider joining the TRANQUILITY study, a clinical trial for people with Chronic Kidney Disease.

Study Overview

What is the TRANQUILITY study?

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.

Who can join the TRANQUILITY study?

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.

What will happen during the study?

Participation in the TRANQUILITY study lasts approximately 12 months. Study participants can expect the following:

Pre-screening (Optional)
Your doctor may decide to check the level of hs-CRP in your blood. If the results of the pre-screen hs-CRP test qualify you for the study you will receive a secondary ICF, to be included in the full study.
Review & Sign the Informed Consent Form
The Informed Consent Form (ICF) contains information about the study including its goals, duration, benefits, risks, tests, and procedures.
Screening Period
Receive further study health assessments to confirm if you qualify for the study. This period can be up to 14 days.
Study Treatment Period
Receive up to 6 doses of TOUR006 or placebo administered subcutaneously, once a month. The study treatment period will last 6 months.
Follow-up Period
Study team will follow-up with patient on days 240, 300, and 365 to determine study health assessments. The follow-up period will last 6 months.

Participation in this study is voluntary. You can ask any questions you have and may leave the study at any time, for any reason.

Will you be compensated?

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.

About the Study Drug

What is the study drug?

The investigational study drug is named TOUR006 and it targets and inhibits the IL-6 (Interleukin 6) pathway.

What is an “investigational drug?”

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.

Will I receive the study drug?

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.

Interested in the TRANQUILITY study?

Contact a study clinic near you!

Contact a Study Clinic

Where can I learn more?

Clinicaltrials.gov

Overview of Clinical Trials

Here are some common questions and answers about study participation.

If you have additional questions about participating in a clinical trial, contact a study clinic near you.

Study Clinic Locations

Find 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.

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