Clinical trial · Observational
Prospective Decision Impact Trial of KidneyIntelX
A Prospective Decision Impact Trial of KidneyIntelX in Patients With Type 2 Diabetes and Existing Chronic Kidney Disease
NCT04960514CI-TRIAL-00121924active not recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Kidney Disease Stage 1 | — | UNRESOLVED | — |
| Chronic Kidney Disease Stage 2 | — | UNRESOLVED | — |
| Chronic Kidney Disease, Stage 3 (Moderate) | — | UNRESOLVED | — |
| Diabetic Kidney Disease | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| KidneyIntelX | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (6)
- measure
- Blood pressure
- timeFrame
- 12 Months
- description
- 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).
- measure
- HbA1c
- timeFrame
- 12 Months
- description
- Proportion (target: 20% increase) of patients that achieve individualized target of HbA1c.
- measure
- ACEi/ARB
- timeFrame
- 12 Months
- description
- Proportion (target: 20% increase) of patients recently treated with statins and or angiotensin-converting-enzyme inhibitors and angiotensin II receptor blockers.
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 23 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.