Rubix LS Diabetic Kidney Disease (DKD) Registry Study

NCT07348718 | Active Not Recruiting

• 1 other identifier: RLS-DKD-REG-001
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetic Kidney Disease (DKD)

Keywords

Diabetic Kidney Disease; Chronic Kidney Disease; Type 2 Diabetes Mellitus; Albuminuria; UACR; eGFR; CKD Progression; eGFR Slope; Patient Registry; Observational Study; Real-World Evidence; Health Equity; Social Determinants of Health; SGLT2 Inhibitor; Finerenone

Outcome Measures

Primary Outcomes (1)

• Annualized Estimated Glomerular Filtration Rate (eGFR) Slope

  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.

  24 months

Secondary Outcomes (1)

• Time to DKD Progression Composite Outcome

  24 months

Interventions

Kidney-Protective Therapies Used in Routine Care DRUG

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.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults (≥18 years) with type 2 diabetes and chronic kidney disease consistent with diabetic kidney disease (e.g., reduced eGFR and/or elevated UACR) receiving routine clinical care at participating sites. Sites will primarily include safety-net systems, community hospitals, and FQHC-affiliated networks, with intentional enrollment strategies to ensure meaningful representation of underserved populations disproportionately affected by DKD. Longitudinal clinical data will be obtained from medical records, supplemented by participant questionnaires capturing patient-reported outcomes and social determinants of health.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Rubix LS: lead

Study Sites (1)

Rubix LS

Lawrence, Massachusetts, 01840, United States

Location

MeSH Terms

Conditions

Diabetic Nephropathies; Renal Insufficiency, Chronic; Diabetes Mellitus, Type 2; Albuminuria

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Renal Insufficiency; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Proteinuria; Urination Disorders; Urological Manifestations; Signs and Symptoms

Study Officials

• Reginald Swift

  Rubix LS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2026
• First Posted: January 16, 2026
• Study Start: December 15, 2025
• Primary Completion: March 31, 2026
• Study Completion: April 1, 2026
• Last Updated: January 16, 2026

Record last verified: 2026-01

Locations

US (1)