Real World Evidence Clinical Utility Study of KidneyIntelX
Recruiting · New York, New York
Always free
Study care at no cost to you
For your time and travel
Many studies pay you back
Most need no insurance or papers
Legal status usually isn't required; we'll tell you each study's requirements
Interpreters available
Ask for your language
Your choice
Voluntary — you can stop anytime
What is this study?
The purpose of this study is to assess the impact of the KidneyIntelX assay utilized as part of the current standard of care on the management of patients seen in the primary care physician's office at Mount Sinai.
It is , overseen by an independent and licensed medical staff.
Read the full clinical description
The purpose of this study is to assess the impact of the KidneyIntelX assay utilized as part of the current standard of care on the management of patients seen in the primary care physician's office at Mount Sinai.
Who this study is looking for
In plain language, from the study's own rules. The study team confirms the full details with you — this isn't a final yes or no.
✅ You may be able to join if…
- •Have type 2 diabetes.
- •Also have chronic (diabetic) kidney disease based on KDIGO CKD staging (G3a–G3b or G1–G2, with A2–A3).
- •Can provide at least 6 months of KidneyIntelX medical history before the study baseline (pre-baseline).
🚫 You may not be able to join if…
- •Do not meet the KidneyIntelX intended-use characteristics.
- •Have eGFR less than 30 or eGFR 60 or higher (as stated) when there is no albuminuria.
- •Have end-stage renal disease (ESRD) or are in renal recovery treatments at enrollment.
- •Are pregnant at the time of enrollment.
- •Are currently hospitalized.
Are you a good fit?
Simplified highlights. The study team always confirms the full details with you.
- ✓People with type 2 diabetes and chronic (diabetic) kidney disease that fits KDIGO CKD stages
- ✓CKD severity must fall within allowed eGFR/albuminuria ranges (not very advanced or mismatched)
- ✓Not pregnant at enrollment
- ✓Not currently hospitalized
- ✓Have at least 6 months of KidneyIntelX medical history before baseline
- !Not for people who are pregnant or breastfeeding
How this study is designed
The real details, in plain words. Tap the underlined words to learn what they mean.
- ✓Everyone in this study receives an active treatment — there is no placebo group.
What to expect, step by step
· This study lasts about 26 weeks (~6 months)- 1
Usually a few weeks
The study team checks whether the study is a good fit for you, with a visit and sometimes lab tests. You can ask any questions before deciding.
- 2
Treatment
About 26 weeksIf you join and choose to continue, you receive the study treatment and are watched closely by medical staff.
- 3
Follow-up
After treatment, the team checks on your health and confirms the visit schedule with you. You can leave the study at any point.
What's being tested
- Diagnostic_test: KidneyIntelX
Has this treatment been tested before?
The study team can share what safety testing has been done so far.
Who's running this study?
Sponsor
Renalytix AI, Inc.
Every study is also reviewed by an independent that protects participants.
What you need to know before you apply
What is this study testing?+
The purpose of this study is to assess the impact of the KidneyIntelX assay utilized as part of the current standard of care on the management of patients seen in the primary care physician's office at Mount Sinai.
Is it safe? Who makes sure of that?+
This is a research study. Every study is reviewed and monitored by an independent ethics board (called an IRB) whose job is to protect participants, and care is overseen by licensed medical staff. You'll be told the known risks before you agree to anything, and you can stop at any time.
Will I get a placebo instead of the real treatment?+
Some studies compare a treatment against a placebo (an inactive version), and some don't. If this one does, the study team will explain your chances of receiving the active treatment before you decide. Nothing is hidden from you.
Do I have to stop taking my current medications?+
It depends on the study. Some let you stay on your current medications and some ask you to adjust them. Never stop a medication on your own — the study team will review everything with you first.
Does it cost anything? Will I be paid?+
Study-related care is provided at no cost to you. Some studies also pay for your time; the coordinator can tell you if this one does. You should never be asked to pay to take part.
Do I need insurance? Will anyone ask about my immigration status?+
No. You do not need health insurance to take part in a research study, and you will not be asked about your immigration status to join. Taking part is about whether you're a medical fit for the study.
What if English isn't my first language?+
You have the right to understand everything before you agree. Study sites can often provide materials or an interpreter in your language — you can ask the coordinator for one.
Is my information private?+
Yes. Your health information is only shared with the study sites you choose to be contacted by, and only to help match and enroll you. It is never sold, and you can ask us to delete it at any time.
Source: ClinicalTrials.gov · NCT04802395 · Locations: New York