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Clinical Trials in the USA / NCT07348718
Active, not recruiting Observational

Rubix LS Diabetic Kidney Disease (DKD) Registry Study

NCT07348718 · tracked via the Priya Life Science USA tracker
Sponsor
Rubix LS
Phase
Observational
Started
2025-12-15
Last updated
2026-01-16

Condition(s) studied

Diabetic Kidney Disease (DKD)

Investigational drug(s) / intervention(s)

Kidney-Protective Therapies Used in Routine Care

Kidney-Protective Therapies Used in Routine Care: Observed medication exposure during usual care (not assigned by the study), including ACE inhibitor/ARB therapy, SGLT2 inhibitors, nonsteroidal mineralocorticoid receptor antagonists, GLP-1 receptor agonists, and other clinician-directed therapies; exposure ascertained from the medical record.

Study summary

Diabetic kidney disease (DKD) is a common complication of type 2 diabetes that can lead to kidney failure and increases the risk of cardiovascular disease. This prospective, observational patient registry will follow adults with type 2 diabetes and DKD who are receiving routine clinical care at participating sites, with intentional enrollment from underserved communities. Health information will be collected from medical records and brief questionnaires (including social and access factors) for up to 24 months to understand DKD progression, real-world treatment patterns, and outcomes. This study does not assign any treatment. With participant consent and appropriate privacy safeguards, de-identified registry data may be shared with researchers to accelerate evidence generation and inform future studies focused on improving outcomes.

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria: Age ≥18 years at the time of enrollment Documented diagnosis of type 2 diabetes mellitus in the medical record Evidence of chronic kidney disease consistent with diabetic kidney disease (DKD), defined by one or more of the following, with evidence of chronicity (present for ≥3 months based on prior laboratory results, diagnosis codes, or clinician documentation): eGFR \<60 mL/min/1.73 m², and/or Urine albumin-to-creatinine ratio (UACR) ≥30 mg/g Receiving ongoing clinical care at a participating site with medical record data available for longitudinal follow-up Able and willing to provide written informed consent (and authorization for medical record review, as applicable) and to complete registry questionnaires Exclusion Criteria: End-stage kidney disease at baseline (maintenance dialysis) or history of kidney transplant Type 1 diabetes mellitus Known primary kidney disease not primarily attributable to diabetes that, in the investigator's judgment, is expected to drive kidney outcomes (e.g., polycystic kidney disease, active glomerulonephritis, lupus nephritis, vasculitis) Inability to provide informed consent or comply with registry procedures (e.g., no feasible longitudinal follow-up through the participating site)

Primary outcome measure(s)

  • Annualized Estimated Glomerular Filtration Rate (eGFR) Slope — 24 months
    Annualized change in kidney function, defined as the slope of estimated glomerular filtration rate (eGFR; mL/min/1.73m2/year) from baseline through 24 months. All available eGFR values obtained in routine clinical care during follow-up will be used. eGFR slope will be estimated using models that account for repeated measures (e.g., linear mixed-effects with random intercept/slope). Baseline eGFR is the value closest to enrollment; more negative slopes indicate faster decline.

Trial sites (1)

FacilityCityRegionStatus
Rubix LS Lawrence Massachusetts

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07348718 on ClinicalTrials.gov ↗ ← All trials in the USA