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OpenTrials
Active, Not Recruiting

NCT Number: NCT05198284

Prospective Decision Impact Clinical Utility Trial of KidneyIntelX

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Diabetic Kidney Disease Chronic Disease Chronic Kidney Disease Stage 1 Chronic Kidney Disease Stage 2 Chronic Kidney Disease Stage 3 Chronic Kidney Diseases Diabetes Complications Diabetes Mellitus Diabetic Nephropathies Disease Attributes Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

23 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mount Sinai Health System

New York, 10029, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

KidneyIntelX

Diagnostic Test

KidneyIntelX is a blood-based clinical diagnostic tool that assesses the risk of progressive kidney function decline in chronic kidney disease patients with type 2 diabetes.

Primary outcomes

  1. Blood pressure

    Time frame: 12 Months

    Proportion (target: 20% increase from prior measurements) of visits in which each participant achieves target blood pressure of <140/90 mmHg (as per the NKF CKD management guidelines).

  2. HbA1c

    Time frame: 12 Months

    Proportion (target: 20% increase) of patients that achieve individualized target of HbA1c.

  3. ACEi/ARB

    Time frame: 12 Months

    Proportion (target: 20% increase) of patients recently treated with statins and or angiotensin-converting-enzyme inhibitors and angiotensin II receptor blockers.

  4. SGLT2/ GLP1

    Time frame: 12 Months

    Proportion (target: 20% increase) of patients recently treated with SGLT2 inhibitors or GLP1 agonists.

  5. Urine albumin to creatinine ratio

    Time frame: 12 Months

    In those with baseline albuminuria, proportion (target: 20%) of patients achieving a 30% decrease in their urine albumin to creatinine ratio from averaged pre-enrollment values to average post-enrollment values through 1 year.

  6. Referrals

    Time frame: 12 Months

    Proportion (target: 20% increase) of patients referred/managed by a dietician, diabetologist, or nephrologist.

Sponsors and collaborators

Lead sponsor

Renalytix AI, Inc.

Industry

Registry information

Official study title

A Prospective Decision Impact Clinical Utility Trial of KidneyIntelX in Patients With Type 2 Diabetes and Existing Chronic Kidney Disease

Important dates

Study start
2021
Primary completion
2023
Study completion
2026
First posted
Jan 20, 2022
Registry last updated
Apr 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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