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Real World Evidence Clinical Utility Study of KidneyIntelX

Real World Evidence Clinical Utility Study of KidneyIntelX in Patients With Type 2 Diabetes and Chronic Kidney Disease

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
23 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at how the KidneyIntelX test affects care for people with type 2 diabetes and long-term kidney disease. The test is used as part of usual care in primary care offices at Mount Sinai.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You have type 2 diabetes and long-term kidney disease from diabetes, in stages G3a–G3b or G1–G2 with A2–A3. These stages describe kidney function and protein levels in urine.

Who can't join

  • You do not meet the requirements for the group KidneyIntelX is meant to be used in.
  • Your kidney filtering rate (eGFR) is below 30, or it is 60 or higher without albumin (a protein) in your urine.
  • You have end-stage kidney disease (kidney failure) or are getting kidney recovery treatments when you join.
  • You are pregnant when you join.
  • You are currently in the hospital.
  • You do not have at least 6 months of medical history before your starting KidneyIntelX test.
  • You are currently taking Enbrel.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Individuals with Type 2 diabetes and concurrent chronic (diabetic) kidney disease (G3a-G3b or G1-G2, A2-A3) per KDIGO CKD staging. Exclusion Criteria: * Patents without the appropriate characteristics as identified in the KidneyIntelX intended use population. * 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 without minimum 6 month pre-baseline KidneyIntelX medical history. * Patients who are currently on Enbrel.

Study sites (1)

NY