Decision Impact Trial of KidneyIntelX

Last updated: April 11, 2024
Sponsor: Renalytix AI, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diabetic Kidney Disease

Treatment

KidneyIntelX

Clinical Study ID

NCT04791358
RAI 20-1001
  • Ages > 23
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 23 years of age or older.
  • Clinical history of confirmed type 2 diabetes.
  • Evidence of DKD Stages 1-3:
  • Baseline eGFR of 30-60 ml/min/1.73m2 (confirmed 3 months apart with at least one valuewithin 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 clinicallyavailable prior).
  • The subject must be able to comprehend and sign an approved informed consent form andother applicable study documents.

Exclusion

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.

Study Design

Total Participants: 1500
Treatment Group(s): 1
Primary Treatment: KidneyIntelX
Phase:
Study Start date:
November 01, 2021
Estimated Completion Date:
December 01, 2024

Connect with a study center

  • Delmar Family Medicine

    Slingerlands, New York 12159
    United States

    Active - Recruiting

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