Diabetic Kidney Disease (DKD)NCT07348718
Rubix LS Diabetic Kidney Disease (DKD) Registry Study
An observational study of Diabetic Kidney Disease (DKD), run by Rubix LS at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetic Kidney Disease (DKD)
- What is being tested?
- Kidney-Protective Therapies Used in Routine Care
- How many people
- 2,000 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2025to 1 Apr 2026
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Diabetic Kidney Disease (DKD)
- Being tested
- Kidney-Protective Therapies Used in Routine Care
- 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
- Medical subject headings
- Diabetic Nephropathies, Renal Insufficiency, Chronic, Diabetes Mellitus, Type 2, Albuminuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kidney-Protective Therapies Used in Routine CareDrug
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months
Secondary outcomes (1)
Time to DKD Progression Composite Outcome
Time from enrollment (baseline) to first occurrence of a DKD progression event, defined as any of the following: sustained ≥40% decline in eGFR from baseline confirmed by a repeat value ≥4 weeks apart; initiation of maintenance dialysis; kidney transplant; or kidney failure-related death. Events will be identified from routine clinical data (EHR and, where available, claims) and validated per protocol. Participants without an event will be censored at last follow-up.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start15 Dec 2025
- Primary completion31 Mar 2026 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Kidney Disease (DKD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Rubix LS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Reginald Swift, Principal investigator, Rubix LS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07348718
- Sponsor's protocol ID
- RLS-DKD-REG-001
- Status last verified
- Jan 2026
- First submitted
- 8 Jan 2026
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07348718
- Acronym / sponsor ID
- RLS-DKD-REG-001
- Conditions
- Diabetic Kidney Disease (DKD)
- Keywords
- Diabetic Kidney Disease, Chronic Kidney Disease, Type 2 Diabetes Mellitus, Albuminuria, UACR, eGFR, CKD Progression, eGFR Slope
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Rubix LSIndustry (pharma, biotech, devices)
- Study start
- 15 Dec 2025 (actual)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 16 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kidney-Protective Therapies Used in Routine CareObserved 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. | Drug | – |
Primary outcome
Annualized Estimated Glomerular Filtration Rate (eGFR) Slope
Time frame: 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.
1 secondary outcome
Time to DKD Progression Composite Outcome
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Diabetic Kidney Disease (DKD)
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QUARTET-DKD: Quadruple Therapy for Type 2 Diabetic Nephropathy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Reginald Swift principal investigator
Rubix LS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Kidney Disease (DKD), run by Rubix LS at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Annualized Estimated Glomerular Filtration Rate (eGFR) Slope (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026.