Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-04-01 @ 2:34 AM
Study NCT ID:
NCT07348718
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2026-01-16
First Post:
2026-01-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rubix LS Diabetic Kidney Disease (DKD) Registry Study
Sponsor:
Rubix LS
Organization:
Study Overview
Official Title:
Rubix LS DKD Equity Registry (RUBIX-DKD): A Prospective Observational Patient Registry to Characterize Diabetic Kidney Disease Trajectories, Treatment Patterns, and Outcomes in Underserved Communities and to Enable a Future Embedded Phase IV Pragmatic Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2026-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Detailed Description:
This study is a prospective, multi-site observational patient registry designed to characterize real-world diabetic kidney disease (DKD) trajectories, care patterns, and outcomes in care settings that serve underserved communities. The registry is intended to generate representative evidence that reflects routine clinical practice and to identify clinical and non-clinical factors that influence DKD progression and care delivery.
Participants will continue to receive all medical care as determined by their treating clinicians; no treatments, diagnostic tests, or clinical management decisions are assigned by the registry. Longitudinal data will be captured primarily from existing sources (e.g., electronic health records and, where available, linked administrative/claims data), including kidney function and albuminuria measures, cardiometabolic risk factors, comorbid conditions, medication exposure and persistence, clinically relevant safety events, and healthcare utilization. Participants will also be invited to complete brief questionnaires to capture patient-reported outcomes and social determinants of health (SDOH), including access and care barriers that may affect treatment initiation, monitoring, and outcomes.
The registry will support descriptive and comparative effectiveness analyses using appropriate observational methods to address confounding and missingness, and will enable development and validation of risk stratification and treatment-response models to inform precision therapy targeting and equitable implementation in real-world settings. A core emphasis is the creation of a high-quality, standardized dataset with clear provenance and data quality checks to support reproducible research.
Data sharing is a foundational component of the registry. With explicit participant consent and privacy safeguards, de-identified participant-level data and supporting documentation may be made available to qualified researchers under the data access approach described in the IPD sharing plan. Finally, findings and infrastructure developed through this registry (e.g., trial-ready sites, validated phenotypes, and risk models) are intended to inform the design of a subsequent Phase IV pragmatic study, which would be conducted under a separate protocol and separately registered, with re-contact and re-consent as applicable.
Participants will continue to receive all medical care as determined by their treating clinicians; no treatments, diagnostic tests, or clinical management decisions are assigned by the registry. Longitudinal data will be captured primarily from existing sources (e.g., electronic health records and, where available, linked administrative/claims data), including kidney function and albuminuria measures, cardiometabolic risk factors, comorbid conditions, medication exposure and persistence, clinically relevant safety events, and healthcare utilization. Participants will also be invited to complete brief questionnaires to capture patient-reported outcomes and social determinants of health (SDOH), including access and care barriers that may affect treatment initiation, monitoring, and outcomes.
The registry will support descriptive and comparative effectiveness analyses using appropriate observational methods to address confounding and missingness, and will enable development and validation of risk stratification and treatment-response models to inform precision therapy targeting and equitable implementation in real-world settings. A core emphasis is the creation of a high-quality, standardized dataset with clear provenance and data quality checks to support reproducible research.
Data sharing is a foundational component of the registry. With explicit participant consent and privacy safeguards, de-identified participant-level data and supporting documentation may be made available to qualified researchers under the data access approach described in the IPD sharing plan. Finally, findings and infrastructure developed through this registry (e.g., trial-ready sites, validated phenotypes, and risk models) are intended to inform the design of a subsequent Phase IV pragmatic study, which would be conducted under a separate protocol and separately registered, with re-contact and re-consent as applicable.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: