NCT04802395 · Renalytix AI, Inc.
Real World Evidence Clinical Utility Study of KidneyIntelX
What this study is about
The purpose of this study is to assess the impact of the KidneyIntelX assay utilized as part of the current the usual treatment on the management of patients seen in the primary care physician's office at Mount Sinai.
View original scientific 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.
Interventions
DIAGNOSTIC_TEST
KidneyIntelX
KidneyIntelX is an in-vitro diagnostic that enables accurate risk prediction of progressive decline in kidney function 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).
Primary outcome measures
Referrals
Time frame: 6 Months
Proportion (target: 20%) of patients referred to a dietician, diabetologist, or nephrologist.
Statins and or ACEi/ARB
Time frame: 6 Months
Proportion (target: 20% increase) of patients treated with statins and or angiotensin-converting-enzyme inhibitors and angiotensin II receptor blockers.
HbA1c
Time frame: 6 Months
Proportion (target: 20% increase) of patients to receive information and or advice on their individualized target of HbA1c.
SGLT2/ GLP1
Time frame: 6 Months
Proportion (target: 20% increase) of patients treated with SGLT2 inhibitors or GLP1 agonists.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Individuals with Type 2 diabetes and concurrent chronic (diabetic) kidney disease (G3a-G3b or G1-G2, A2-A3) per KDIGO CKD staging.
Exclusion criteria
- Patents without the appropriate characteristics as identified in the KidneyIntelX intended use population.
- 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 without minimum 6 month pre-baseline KidneyIntelX medical history.
- Patients who are currently on Enbrel.
Where
- New York, New York
Collaborators
Mount Sinai Hospital, New York
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 12, 2024 · Source of record for eligibility and locations