NCT05198284

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
6mo left

Started Nov 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress90%
Nov 2021Nov 2026

Study Start

First participant enrolled

November 1, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 5, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 20, 2022

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Expected
Last Updated

April 12, 2024

Status Verified

April 1, 2024

Enrollment Period

2.1 years

First QC Date

January 5, 2022

Last Update Submit

April 11, 2024

Conditions

Diabetic Kidney DiseaseChronic Kidney DiseasesChronic Kidney Disease Stage 1Chronic Kidney Disease Stage 2Chronic Kidney Disease Stage 3

Outcome Measures

Primary Outcomes (6)

  • Blood pressure

    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).

    12 Months

  • HbA1c

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

    12 Months

  • ACEi/ARB

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

    12 Months

  • SGLT2/ GLP1

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

    12 Months

  • Urine albumin to creatinine ratio

    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.

    12 Months

  • Referrals

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

    12 Months

Interventions

KidneyIntelXDIAGNOSTIC_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.

Eligibility Criteria

Age23 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mount Sinai Health System

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Diabetic NephropathiesRenal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesRenal InsufficiencyChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • David W Lam, MD

    Mount Sinai Health System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2022

First Posted

January 20, 2022

Study Start

November 1, 2021

Primary Completion

December 1, 2023

Study Completion (Estimated)

November 1, 2026

Last Updated

April 12, 2024

Record last verified: 2024-04

Locations

US(1)