RECRUITING

Real World Evidence Clinical Utility Study of KidneyIntelX

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to assess the impact of the KidneyIntelX assay utilized as part of the current standard of care on the management of patients seen in the primary care physician's office at Mount Sinai.

Official Title

Real World Evidence Clinical Utility Study of KidneyIntelX in Patients With Type 2 Diabetes and Chronic Kidney Disease

Quick Facts

Study Start:2021-03-02
Study Completion:2026-12-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04802395

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:23 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Individuals with Type 2 diabetes and concurrent chronic (diabetic) kidney disease (G3a-G3b or G1-G2, A2-A3) per KDIGO CKD staging.
  1. * Patents without the appropriate characteristics as identified in the KidneyIntelX intended use population.
  2. * Patients with eGFR \<30 or ≥ 60 ml/min/1.73m2 without albuminuria.
  3. * Patients with ESRD or on renal recovery treatments at time of enrollment.
  4. * Patients who are pregnant at the time of enrollment.
  5. * Patients who are currently hospitalized.
  6. * Patients without minimum 6 month pre-baseline KidneyIntelX medical history.
  7. * Patients who are currently on Enbrel.

Contacts and Locations

Study Contact

Roger Tun
CONTACT
646-397-3970
rtun@renalytix.com

Study Locations (Sites)

Mount Sinai Health System
New York, New York, 10029
United States

Collaborators and Investigators

Sponsor: Renalytix AI, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-03-02
Study Completion Date2026-12-01

Study Record Updates

Study Start Date2021-03-02
Study Completion Date2026-12-01

Terms related to this study

Additional Relevant MeSH Terms

  • Chronic Kidney Diseases
  • Diabetic Kidney Disease