Prospective Decision Impact Trial of KidneyIntelX

Prospective Decision Impact Trial of KidneyIntelX
warningThe safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT04960514
Recruitment Status : **RECRUITING NOW**

First Posted : July 14, 2021

Last Update Posted : October 28, 2022

Sponsor:

Information provided by (Responsible Party):

Renalytix AI, Inc.

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Brief Summary:

The current 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.

Diabetic Kidney Disease Chronic Kidney Disease Stage 1 Chronic Kidney Disease Stage 2 Chronic Kidney Disease, Stage 3 (Moderate)Diagnostic Test: KidneyIntelX

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Study Type :Observational
Estimated Enrollment :2000 participants
Observational Model:Cohort
Time Perspective:Prospective
Official Title:A Prospective Decision Impact Trial of KidneyIntelX in Patients With Type 2 Diabetes and Existing Chronic Kidney Disease
Actual Study Start Date :November 22, 2021
Estimated Primary Completion Date :November 1, 2023
Estimated Study Completion Date :December 1, 2026
Resource links provided by the National Library of Medicine NIH NLM ABRV BLK 4

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Intervention Details:

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Primary Outcome Measures :

  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.

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Information from the National Library of Medicine NIH NLM ABRV BLK 4

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:  23 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:  All
Accepts Healthy Volunteers:  No
Sampling Method:  Non-Probability Sample

Patients with Type 2 diabetes and existing chronic kidney disease stages 1-3.

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.

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Contact: Roger Tun646-397-3970 ext 106rtun@renalytix.com

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Atrium Health Wake Forest Baptist – Family Medicine – Piedmont Plaza
Winston-Salem, North Carolina, United States, 27104
Contact: Benjamin Bagwell         

Renalytix AI, Inc.

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Responsible Party:Renalytix AI, Inc.
ClinicalTrials.gov Identifier:NCT04960514    
Other Study ID Numbers:RAI 19-1003
First Posted:July 14, 2021    Key Record Dates
Last Update Posted:October 28, 2022
Last Verified:October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:Undecided

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Studies a U.S. FDA-regulated Drug Product:No
Studies a U.S. FDA-regulated Device Product:No

Additional relevant MeSH terms:

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Kidney Diseases
Renal Insufficiency, Chronic
Diabetic Nephropathies
Urologic Diseases
Renal Insufficiency
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases

Source: View full study details on ClinicalTrials.gov

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

October 29, 2022Comments OffClinicalTrials.gov | Endocrinology Clinical Trials | Endocrinology Studies | US National Library of Medicine
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