Decision Impact Trial of KidneyIntelX
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.
Conditions:
🦠 Diabetic Kidney Disease
🗓️ Study Start (Actual) 1 November 2021
🗓️ Primary Completion (Estimated) 1 November 2024
✅ Study Completion (Estimated) 1 December 2024
👥 Enrollment (Estimated) 1500
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Slingerlands, New York, United States

📋 Eligibility Criteria

Description

    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 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.
Ages Eligible for Study: 23 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 4 March 2021
  • First Submitted that Met QC Criteria 9 March 2021
  • First Posted 10 March 2021

Study Record Updates

  • Last Update Submitted that Met QC Criteria 11 April 2024
  • Last Update Posted 12 April 2024
  • Last Verified April 2024