Active — Not RecruitingNot Applicable

Prospective Decision Impact Clinical Utility Trial of KidneyIntelX

United States2,000 participantsStarted 2021-11-01

Plain-language summary

The clinical utility trial is designed to evaluate how the results of KidneyIntelX test / platform impacts on the clinical management of type 2 diabetes patients identified as increased risk for rapid kidney function decline within 5-years.

Who can participate

Age range

23 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 23 years of age or older. * Clinical history of confirmed type 2 diabetes. * Evidence of DKD Stages 1-3: * Baseline eGFR of 30-59 ml/min/1.73m2 (confirmed 3 months apart with at least one value within 1 year prior to enrollment) * Individuals with eGFR ≥60 ml/min/1.73m2 and albuminuria (UACR ≥30mg/g) * All patients will have a HbA1c, eGFR, urine albumin and urine creatinine, eGFR, available from within 12 months of enrollment (to be obtained if not clinically available prior). * The subject must be able to comprehend and sign an approved informed consent form and other applicable study documents. Exclusion Criteria: * Patients with eGFR \<30 or ≥ 60 ml/min/1.73m2 without albuminuria. * Patients with ESRD or on renal recovery treatments at time of enrollment. * Patients who are pregnant at the time of enrollment. * Patients who are currently hospitalized. * Patients who are currently on Enbrel.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Blood pressure

Timeframe: 12 Months

HbA1c

Timeframe: 12 Months

ACEi/ARB

Timeframe: 12 Months

SGLT2/ GLP1

Timeframe: 12 Months

Urine albumin to creatinine ratio

Timeframe: 12 Months

Referrals

Timeframe: 12 Months

Trial details

NCT IDNCT05198284

SponsorRenalytix AI, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2023-12-01

View on ClinicalTrials.gov More Diabetic Kidney Disease trials

Who can participate

Age range

23 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.