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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT04960514 |
|
Recruitment Status : **RECRUITING NOW**
First Posted : July 14, 2021 Last Update Posted : October 28, 2022 |
Sponsor:
Information provided by (Responsible Party):
Renalytix AI, Inc.
Brief Summary:
The current 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.
| Diabetic Kidney Disease Chronic Kidney Disease Stage 1 Chronic Kidney Disease Stage 2 Chronic Kidney Disease, Stage 3 (Moderate) | Diagnostic Test: KidneyIntelX |
| Study Type : | Observational |
| Estimated Enrollment : | 2000 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | A Prospective Decision Impact Trial of KidneyIntelX in Patients With Type 2 Diabetes and Existing Chronic Kidney Disease |
| Actual Study Start Date : | November 22, 2021 |
| Estimated Primary Completion Date : | November 1, 2023 |
| Estimated Study Completion Date : | December 1, 2026 |
- Blood pressure [ Time Frame: 12 Months ]
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).
- HbA1c [ Time Frame: 12 Months ]
Proportion (target: 20% increase) of patients that achieve individualized target of HbA1c.
- ACEi/ARB [ Time Frame: 12 Months ]
Proportion (target: 20% increase) of patients recently treated with statins and or angiotensin-converting-enzyme inhibitors and angiotensin II receptor blockers.
- SGLT2/ GLP1 [ Time Frame: 12 Months ]
Proportion (target: 20% increase) of patients recently treated with SGLT2 inhibitors or GLP1 agonists.
- Urine albumin to creatinine ratio [ Time Frame: 12 Months ]
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.
- Referrals [ Time Frame: 12 Months ]
Proportion (target: 20% increase) of patients referred/managed by a dietician, diabetologist, or nephrologist.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study:  | 23 Years and older  (Adult, Older Adult) |
| Sexes Eligible for Study: Â | All |
| Accepts Healthy Volunteers: Â | No |
| Sampling Method: Â | Non-Probability Sample |
Patients with Type 2 diabetes and existing chronic kidney disease stages 1-3.
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04960514
| Contact: Roger Tun | 646-397-3970 ext 106 | rtun@renalytix.com |
| Atrium Health Wake Forest Baptist – Family Medicine – Piedmont Plaza | |
| Winston-Salem, North Carolina, United States, 27104 | |
| Contact: Benjamin Bagwell       | |
Renalytix AI, Inc.
| Responsible Party: | Renalytix AI, Inc. |
| ClinicalTrials.gov Identifier: | NCT04960514 Â Â |
| Other Study ID Numbers: | RAI 19-1003 |
| First Posted: | July 14, 2021 Â Â Key Record Dates |
| Last Update Posted: | October 28, 2022 |
| Last Verified: | October 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
| Kidney Diseases Renal Insufficiency, Chronic Diabetic Nephropathies Urologic Diseases |
Renal Insufficiency Diabetes Complications Diabetes Mellitus Endocrine System Diseases |
Source: View full study details on ClinicalTrials.gov
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
