Decision Impact Trial of KidneyIntelX

NCT04791358 | Recruiting

• 1 other identifier: RAI 20-1001
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetic Kidney Disease

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

KidneyIntelX DIAGNOSTIC_TEST

KidneyIntelX is an in-vitro diagnostic that enables accurate risk prediction of progressive decline in kidney function and kidney failure in patients with type 2 diabetes and existing CKD at stages 1-3 (eGFR of 30 to 59 ml/min/1.73m2, or eGFR ≥ 60 ml/min/1.73m2 and uACR ≥ 30 mg/g).

Eligibility Criteria

• Age: 23 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-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 30-60 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.

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.

Sponsors & Collaborators

• Renalytix AI, Inc.: lead

Study Sites (1)

Delmar Family Medicine

Slingerlands, New York, 12159, United States

RECRUITING

MeSH Terms

Conditions

Diabetic Nephropathies

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Central Study Contacts

Roger Tun

CONTACT

646-397-3970; rtun@renalytix.com

Study Design

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

Study Record Dates

• First Submitted: March 4, 2021
• First Posted: March 10, 2021
• Study Start: November 1, 2021
• Primary Completion: November 1, 2024
• Study Completion: December 1, 2024
• Last Updated: April 12, 2024

Record last verified: 2024-04

Locations

US (1)