Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05198284
Other study ID # RAI 19-1002
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date November 1, 2021
Est. completion date November 1, 2026

Study information

Verified date April 2024
Source Renalytix AI, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 2000
Est. completion date November 1, 2026
Est. primary completion date December 1, 2023
Accepts healthy volunteers No
Gender All
Age group 23 Years and older
Eligibility 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.

Study Design


Intervention

Diagnostic Test:
KidneyIntelX
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.

Locations

Country Name City State
United States Mount Sinai Health System New York New York

Sponsors (1)

Lead Sponsor Collaborator
Renalytix AI, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary HbA1c Proportion (target: 20% increase) of patients that achieve individualized target of HbA1c. 12 Months
Primary 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
Primary SGLT2/ GLP1 Proportion (target: 20% increase) of patients recently treated with SGLT2 inhibitors or GLP1 agonists. 12 Months
Primary 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
Primary Referrals Proportion (target: 20% increase) of patients referred/managed by a dietician, diabetologist, or nephrologist. 12 Months
See also
  Status Clinical Trial Phase
Recruiting NCT06386172 - Electronic Decision-support System to Improve Detection and Care of Patients With Chronic Kidney Disease in Stockholm N/A
Recruiting NCT04910867 - APOL1 Genetic Testing Program for Living Donors N/A
Completed NCT03434145 - Changes of Ocular Structures After Hemodialysis in Patients With Chronic Kidney Diseases N/A
Recruiting NCT04984226 - Sodium Bicarbonate and Mitochondrial Energetics in Persons With CKD Phase 2
Active, not recruiting NCT05887817 - Effects of Finerenone on Vascular Stiffness and Cardiorenal Biomarkers in T2D and CKD (FIVE-STAR) Phase 4
Recruiting NCT05318196 - Molecular Prediction of Development, Progression or Complications of Kidney, Immune or Transplantation-related Diseases
Terminated NCT05022329 - COVID-19 Vaccine Boosters in Patients With CKD Phase 2/Phase 3
Not yet recruiting NCT04925661 - HEC53856 Phase Ib Study in Patients With Non-dialysis Renal Anemia Phase 1
Recruiting NCT04961164 - Resistant Starch Prebiotic Effects in Chronic Kidney Disease N/A
Completed NCT05015647 - Low Protein Diet in CKD Patients at Risk of Malnutrition N/A
Completed NCT03426787 - Helping Empower Liver and Kidney Patients N/A
Recruiting NCT06094231 - Treating Patients With Renal Impairment and Altered Glucose MetAbolism With TherapeutIc Carbohydrate Restriction and Sglt2-Inhibiton - a Pilot Study N/A
Completed NCT04363554 - The Kidneys Ability to Concentrate and Dilute Urine in Patients With Autosomal Dominant Polycystic Kidney Disease N/A
Recruiting NCT04831021 - Pre- or Per-dialytic Physical Exercise : a Cardioprotective Role? N/A
Terminated NCT04877847 - Multi-Center Trial Utilizing Low Frequency Ultrasound in the Prevention of Post-Contrast Acute Kidney Injury N/A
Recruiting NCT04422652 - Combination of Novel Therapies for CKD Comorbid Depression Phase 2
Completed NCT05055362 - Effect a Honey, Spice-blended Baked Good Has on Salivary Inflammation Markers in Adults: a Pilot Study N/A
Not yet recruiting NCT06330480 - Check@Home: General Population Screening for Early Detection of Atrial Fibrillation and Chronic Kidney Disease N/A
Recruiting NCT03176862 - Left Ventricular Fibrosis in Chronic Kidney Disease N/A
Terminated NCT02539680 - Intestinal Phosphate Transporter Expression in CKD Patients N/A