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Anti-inflammatory

TOUR006 - 50 MG for Chronic Kidney Disease (TRANQUILITY Trial)

Q: How many individuals are currently enrolled in this research trial?

This study requires the recruitment of 120 eligible participants who meet the defined inclusion criteria. Patients have the opportunity to enroll at various locations, including Site - 0104 in Phoenix, <a href="https://www.withpower.com/clinical-trials/arizona">Arizona</a> and Site - 0102 in Fort Mill, <a href="https://www.withpower.com/clinical-trials/south-carolina">South carolina</a>.

Q: Are multiple facilities within the city conducting this study?

Currently, enrollment for this study is open at 5 sites. These locations are situated in Phoenix, Fort Mill, and Rapid City along with an additional 2 undisclosed places. Opting for the nearest site can reduce travel requirements when partaking in the trial.

Q: Has the FDA granted approval for TOUR006 - 50 MG?

Given the nature of this Phase 2 trial, our team at Power has assessed TOUR006 - 50 MG with a safety rating of 2 on a scale from 1 to 3. This grade reflects existing safety data without evidence supporting efficacy yet.

Q: Is the enrollment process for this study currently ongoing?

As per the details on clinicaltrials.gov, this study is actively seeking eligible individuals. The trial was initially listed on May 1st, 2024, and last modified on May 6th of the same year.

Phase 2

Recruiting

Research Sponsored by Tourmaline Bio, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥18 years at time of ICF signature

Diagnosis of chronic kidney disease, eGFR ≥15 and <60 mL/min/1.73 m2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 365 days

Awards & highlights

TRANQUILITY Trial Summary

This trial will look at how safe and well-tolerated a new drug is when given as a shot under the skin every three months or every month to people with chronic kidney disease and high levels of

Who is the study for?

This trial is for adults over 18 with chronic kidney disease who have an eGFR between ≥15 and <60 mL/min/1.73 m2 and elevated hs-CRP levels (≥2.0 mg/L but <15 mg/L). Participants must have received a COVID-19 vaccine at least 30 days prior to screening and agree to follow contraception guidelines.Check my eligibility

What is being tested?

The study tests TOUR006 at different doses (25 MG, 50 MG, and 15 MG) versus a placebo in patients with chronic kidney disease. It aims to assess the drug's safety, how well it's tolerated, its pharmacokinetics (how it moves through the body), and its ability to lower CRP when given quarterly or monthly by injection.See study design

What are the potential side effects?

While specific side effects of TOUR006 are not listed here, common ones may include reactions at the injection site, potential allergic responses, changes in blood markers related to kidney function or inflammation levels.

TRANQUILITY Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Select...

My kidney function is reduced but not severely.

TRANQUILITY Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 365 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~365 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 365 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Secondary outcome measures

Evaluate the effects of TOUR006 compared with placebo on hs-CRP

Evaluate the pharmacokinetics by measuring serum concentrations of TOUR006

Evaluate the safety and tolerability of TOUR006 in participants with elevated cardiovascular risk and CKD

TRANQUILITY Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: TOUR006 - 50 MGExperimental Treatment1 Intervention

50 mg administered subcutaneously at Day 1 and Day 90 (Placebo administered at 30, 60, 120, and 150 Day timepoints)

Group II: TOUR006 - 25 MGExperimental Treatment1 Intervention

25 mg administered subcutaneously at Day 1 and Day 90 (Placebo administered at 30, 60, 120, and 150 Day timepoints)

Group III: TOUR006 - 15 MGExperimental Treatment1 Intervention

15 mg administered subcutaneously at Days 1, 30, 60, 90, 120, and 150

Group IV: PlaceboPlacebo Group1 Intervention

Administered subcutaneously at Days 1, 30, 60, 90, 120, and 150

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Tourmaline Bio, Inc.Lead Sponsor

1 Previous Clinical Trials

81 Total Patients Enrolled

Clinical TrialsStudy DirectorTourmaline Bio

2,202 Previous Clinical Trials

888,794 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are currently enrolled in this research trial?

"This study requires the recruitment of 120 eligible participants who meet the defined inclusion criteria. Patients have the opportunity to enroll at various locations, including Site - 0104 in Phoenix, Arizona and Site - 0102 in Fort Mill, South carolina."

Answered by AI

Are multiple facilities within the city conducting this study?

"Currently, enrollment for this study is open at 5 sites. These locations are situated in Phoenix, Fort Mill, and Rapid City along with an additional 2 undisclosed places. Opting for the nearest site can reduce travel requirements when partaking in the trial."

Answered by AI

Has the FDA granted approval for TOUR006 - 50 MG?

"Given the nature of this Phase 2 trial, our team at Power has assessed TOUR006 - 50 MG with a safety rating of 2 on a scale from 1 to 3. This grade reflects existing safety data without evidence supporting efficacy yet."

Answered by AI

Is the enrollment process for this study currently ongoing?

"As per the details on clinicaltrials.gov, this study is actively seeking eligible individuals. The trial was initially listed on May 1st, 2024, and last modified on May 6th of the same year."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "A Study to Evaluate TOUR006 in Patients With Chronic Kidney Disease and Elevated Hs-CRP". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06362759.

All > Chronic Kidney Disease > Greensboro