Chronic Kidney DiseasePhase 4HOLISTICNCT07811427
Heart-Kidney-Diabetes Multidisciplinary Care MOdels for CardiovascuLar Health In Patients With Chronic Kidney DiSease and Diabetes: A PragmaTIC Cluster Randomized Controlled Trial (HOLISTIC)
A Phase 4 study testing The intervention with the MCM is Kidney-Heart GDMT initiation and titration for dose optimization (as clinically tolerated), within 4 months of enrollment in the study. in people with Chronic Kidney Disease and Type II Diabetes, run by Baim Institute for Clinical Research.
Trial summary
Our overarching goal of this study is to provide rigorous evidence for using an accelerated risk-based approach to implementing guideline directed medical therapies (GDMT) using a multidisciplinary care model (MCM) versus a usual care model (UCM) to improve a composite GDMT score, reduce kidney disease and heart… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease, Type II Diabetes
- What is being tested?
- The intervention with the MCM is Kidney-Heart GDMT initiation and titration for dose optimization (as clinically tolerated), within 4 months of enrollment in the study.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 570 participants
- Where
- No sites listed yet
- Study dates
- Dec 2026to May 2029
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provide written informed consent
- Adults ≥18 years of age with T2D and CKD at high or very high KDIGO risk (Figure A1): eGFR 45-59 mL/min/1.73 m2 and UACR >300 mg/g OR eGFR 30-44 mL/min/1.73 m2 and UACR >30 mg/g OR any eGFR <30 mL/min/1.73 m2.
Who cannot join
- Advanced HF on inotrope support or requiring left ventricular assist device support.
- Chronic hemodialysis or peritoneal dialysis or kidney transplant
- Life expectancy of <1-year, and vulnerable populations such as pregnant women, incarcerated individuals, or those with active psychiatric illness.
- Unreliable or non-compliant, including patients with known history of alcoholism, drug abuse, or serious psychiatric disorder; as well as patients unwilling to abide by the requirements of the protocol
- Any condition that would interfere with the patient's ability to comply with study instructions, might confound the interpretation of the study, or put the patient at risk
- Personnel, or any relative of personnel, of the Sponsor, the CRO, or the investigative site(s)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Patricia Wedge M Chief Operating Officer, RN, BSN, CCRC contact
About this study
Our overarching goal of this study is to provide rigorous evidence for using an accelerated risk-based approach to implementing guideline directed medical therapies (GDMT) using a multidisciplinary care model (MCM) versus a usual care model (UCM) to improve a composite GDMT score, reduce kidney disease and heart failure (HF) events, hospitalizations, and total healthcare costs for patients with type 2 diabetes (T2D) and CKD with high- to very-high Kidney Disease: Improving Global Outcomes (KDIGO) risk.
Read the detailed description
The study is designed to provide evidence for MCM versus UCM to improve a composite GDMT score, reduce major kidney and cardiovascular risks, reduce hospitalizations (and thereby healthcare costs), and improve QoL, for patients with T2D and high and very high KDIGO CKD risk. These Specific Aims address critical gaps including lack of patient access to subspecialists, PCC and patient inertia, and inadequate infrastructure to optimize nutrition. The MCM is designed to increase GDMT uptake across the health system, PCC, and patient domains. Outside the US, MCMs in patients with CKD and T2D have shown promise by reducing CKM risk factors, healthcare costs, subspecialty clinic visits, and hospitalizations. Given lack of patient access to subspecialists in the US,32 especially nephrologists, a specialist-dominant model for GDMT uptake and optimization may not be feasible in many health systems. Notably, PCCs are also in shortage by workforce capacity, and they have large patient panels, severe time constraints, and competing priorities. Therefore, maintaining vital PCC and patient relationships, while bringing a primary-care-based CKM pharmacist onboard with consulting subspecialists, is a way forward. HOLISTIC will answer a call for research on team-based primary care to alleviate physician shortages for under-served health needs such as T2D and CKD. This approach can also capitalize on successes pioneered by telehealth during the COVID-19 pandemic for complex chronic conditions by assisting PCCs through pharmacist led CMM. Finally, it allows a strategic re-purposing of existing resources (pharmacist clinicians) who can support PCCs and lead CMM and GDMT deployment in a risk-appropriate and timely fashion, to demonstrate value to this alternate model across optimal care delivery, clinical outcomes, cost savings/return on investment.
- Conditions
- Chronic Kidney Disease, Type II Diabetes
- Being tested
- The intervention with the MCM is Kidney-Heart GDMT initiation and titration for dose optimization (as clinically tolerated), within 4 months of enrollment in the study.
- Keywords
- Cardiovascular-kidney-metabolic, Multidisciplinary Care Model, Guideline Directed Medical Therapies
- Medical subject headings
- Renal Insufficiency, Chronic, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The intervention with the MCM is Kidney-Heart GDMT initiation and titration for dose optimization (as clinically tolerated), within 4 months of enrollment in the study.Other
The intervention with the MCM is Kidney-Heart GDMT initiation and titration for dose optimization (as clinically tolerated), within 4 months of enrollment in the study.
| Study group | Role | What they receive |
|---|---|---|
| multidisciplinary care model (MCM) intervention | Active comparator | This model/arm will include Primary Care Clinician (PCC) delivered care assisted by a Multidisciplinary Heart-Kidney-Diabetes Care Team Model (MCM) Receives: Other: The intervention with the MCM is Kidney-Heart GDMT initiation and titration for dose optimization (as clinically tolerated), within 4 months of enrollment in the study. |
| a usual care model (UCM) | No intervention | This model/arm will include PCC delivered care with as-needed Local Specialist Support, representing the Usual Care Model (UCM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Composite Guideline-Directed Medical Therapy (GDMT) Score
Composite GDMT calculated from baseline to Month 12 across five pre-defined medication classes (RAS inhibitors, SGLT2 inhibitors, GLP-1 receptor antagonists, non-steroidal mineralocorticoid receptor antagonists, and statins). The score is the sum of baseline use and changes during follow-up (+1 for initiation of a medication class and -1 for discontinuation). This represents a single composite outcome.
Measured: Baseline to 12 months
Secondary outcomes (7)
Number of participants with all-cause mortality
Number of participants who die from any cause during the 12-month follow-up.
Measured: 12 Months
Outcome Measure: Number of Participants with Worsening Kidney Disease
Number of participants experiencing worsening kidney disease, defined according to the study protocol as ≥40% decline in estimated glomerular filtration rate (eGFR) from enrollment, eGFR <10 mL/min/1.73 m², initiation of dialysis, or kidney transplantation.
Measured: 12 Months
Outcome Measure: Number of Participants with Worsening Heart Failure Events
Number of participants experiencing worsening heart failure, including heart failure hospitalization or urgent heart failure visit.
Measured: 12 Months
Outcome Measure: Major Adverse Cardiovascular Events (MACE)
Number of participants experiencing major adverse cardiovascular events, defined as the composite of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke
Measured: 12 Months
Outcome Measure: Change from Baseline in Kidney Disease Quality of Life (KDQOL-36) Summary Score
Mean change from baseline to Month 12 in the Kidney Disease Quality of Life (KDQOL-36) summary score. Unit of Measure: Points
Measured: Baseline and 12 Months
Change in PREVENT-CVD Predicted Cardiovascular Risk Score
Change from baseline to 12 months in predicted cardiovascular risk estimated using the PREVENT-CVD risk calculator among participants without established cardiovascular disease at baseline.
Unit of Measure: Percentage points (%)
Measured: 12 Months
eGFR Total Slope
Annualized rate of change in estimated glomerular filtration rate (eGFR) from baseline through 12 months.
Unit of Measure: mL/min/1.73 m²/year
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2026
- Study startDec 2026 (estimated)
- Primary completionMay 2029 (estimated)
- Study completionMay 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The proposed study uses an intervention that requires clinic-level randomization, which minimizes contamination between patients cared for within the same clinic. Therefore, we propose to conduct a cluster randomized, two-group trial of a MCM versus UCM. Each of the 6 health systems will have 6 clinics, with each clinic representing a cluster as the unit of randomization. Block randomization will be completed using a computer-generated algorithm to allocate clinics within the site randomly at a 1:1 ratio to MCM or UCM. The analysis of the primary outcome will be stratified by study site. Study outcomes pertain to the individual participant rather than the clinic.
- Masking
- None (open label)
- Enrolment
- 570 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baim Institute for Clinical Research
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07811427
- Sponsor's protocol ID
- BICR 2026-02
- Acronym
- HOLISTIC
- Status last verified
- Sep 2026
- First submitted
- 5 Jun 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heart-Kidney-Diabetes Multidisciplinary Care MOdels for CardiovascuLar Health In Patients With Chronic Kidney DiSease and Diabetes: A PragmaTIC Cluster Randomized Controlled Trial (HOLISTIC)
- ClinicalTrials.gov ID
- NCT07811427
- Acronym / sponsor ID
- HOLISTIC / BICR 2026-02
- Conditions
- Chronic Kidney Disease, Type II Diabetes
- Keywords
- Cardiovascular-kidney-metabolic, Multidisciplinary Care Model, Guideline Directed Medical Therapies
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 570 participants (estimated)
- Lead sponsor
- Baim Institute for Clinical ResearchUniversity, hospital or other
- Study start
- Dec 2026 (estimated)
- Primary completion
- May 2029 (estimated)
- Study completion
- May 2029 (estimated)
- First posted
- 10 Sep 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.
Our overarching goal of this study is to provide rigorous evidence for using an accelerated risk-based approach to implementing guideline directed medical therapies (GDMT) using a multidisciplinary care model (MCM) versus a usual care model (UCM) to improve a composite GDMT score, reduce kidney disease and heart failure (HF) events, hospitalizations, and total healthcare costs for patients with type 2 diabetes (T2D) and CKD with high- to very-high Kidney Disease: Improving Global Outcomes (KDIGO) risk.
Detailed description
The study is designed to provide evidence for MCM versus UCM to improve a composite GDMT score, reduce major kidney and cardiovascular risks, reduce hospitalizations (and thereby healthcare costs), and improve QoL, for patients with T2D and high and very high KDIGO CKD risk. These Specific Aims address critical gaps including lack of patient access to subspecialists, PCC and patient inertia, and inadequate infrastructure to optimize nutrition. The MCM is designed to increase GDMT uptake across the health system, PCC, and patient domains. Outside the US, MCMs in patients with CKD and T2D have shown promise by reducing CKM risk factors, healthcare costs, subspecialty clinic visits, and hospitalizations. Given lack of patient access to subspecialists in the US,32 especially nephrologists, a specialist-dominant model for GDMT uptake and optimization may not be feasible in many health systems. Notably, PCCs are also in shortage by workforce capacity, and they have large patient panels, severe time constraints, and competing priorities. Therefore, maintaining vital PCC and patient relationships, while bringing a primary-care-based CKM pharmacist onboard with consulting subspecialists, is a way forward. HOLISTIC will answer a call for research on team-based primary care to alleviate physician shortages for under-served health needs such as T2D and CKD. This approach can also capitalize on successes pioneered by telehealth during the COVID-19 pandemic for complex chronic conditions by assisting PCCs through pharmacist led CMM. Finally, it allows a strategic re-purposing of existing resources (pharmacist clinicians) who can support PCCs and lead CMM and GDMT deployment in a risk-appropriate and timely fashion, to demonstrate value to this alternate model across optimal care delivery, clinical outcomes, cost savings/return on investment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The proposed study uses an intervention that requires clinic-level randomization, which minimizes contamination between patients cared for within the same clinic. Therefore, we propose to conduct a cluster randomized, two-group trial of a MCM versus UCM. Each of the 6 health systems will have 6 clinics, with each clinic representing a cluster as the unit of randomization. Block randomization will be completed using a computer-generated algorithm to allocate clinics within the site randomly at a 1:1 ratio to MCM or UCM. The analysis of the primary outcome will be stratified by study site. Study outcomes pertain to the individual participant rather than the clinic.
| Arm | Type | Receives |
|---|---|---|
| multidisciplinary care model (MCM) intervention | Active comparator | Other: The intervention with the MCM is Kidney-Heart GDMT initiation and titration for dose optimization (as clinically tolerated), within 4 months of enrollment in the study.This model/arm will include Primary Care Clinician (PCC) delivered care assisted by a Multidisciplinary Heart-Kidney-Diabetes Care Team Model (MCM) |
| a usual care model (UCM) | No intervention | –This model/arm will include PCC delivered care with as-needed Local Specialist Support, representing the Usual Care Model (UCM) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Provide written informed consent
- Adults ≥18 years of age with T2D and CKD at high or very high KDIGO risk (Figure A1): eGFR 45-59 mL/min/1.73 m2 and UACR >300 mg/g OR eGFR 30-44 mL/min/1.73 m2 and UACR >30 mg/g OR any eGFR <30 mL/min/1.73 m2.
Key exclusion criteria (6 listed)
- Advanced HF on inotrope support or requiring left ventricular assist device support.
- Chronic hemodialysis or peritoneal dialysis or kidney transplant
- Life expectancy of <1-year, and vulnerable populations such as pregnant women, incarcerated individuals, or those with active psychiatric illness.
- Unreliable or non-compliant, including patients with known history of alcoholism, drug abuse, or serious psychiatric disorder; as well as patients unwilling to abide by the requirements of the protocol
- Any condition that would interfere with the patient's ability to comply with study instructions, might confound the interpretation of the study, or put the patient at risk
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 |
|---|---|---|
| The intervention with the MCM is Kidney-Heart GDMT initiation and titration for dose optimization (as clinically tolerated), within 4 months of enrollment in the study.The intervention with the MCM is Kidney-Heart GDMT initiation and titration for dose optimization (as clinically tolerated), within 4 months of enrollment in the study. | Other | multidisciplinary care model (MCM) intervention |
Primary outcome
Change in Composite Guideline-Directed Medical Therapy (GDMT) Score
Time frame: Baseline to 12 months
Composite GDMT calculated from baseline to Month 12 across five pre-defined medication classes (RAS inhibitors, SGLT2 inhibitors, GLP-1 receptor antagonists, non-steroidal mineralocorticoid receptor antagonists, and statins). The score is the sum of baseline use and changes during follow-up (+1 for initiation of a medication class and -1 for discontinuation). This represents a single composite outcome.
7 secondary outcomes
Number of participants with all-cause mortality
Time frame: 12 Months
Outcome Measure: Number of Participants with Worsening Kidney Disease
Time frame: 12 Months
Outcome Measure: Number of Participants with Worsening Heart Failure Events
Time frame: 12 Months
Outcome Measure: Major Adverse Cardiovascular Events (MACE)
Time frame: 12 Months
Outcome Measure: Change from Baseline in Kidney Disease Quality of Life (KDQOL-36) Summary Score
Time frame: Baseline and 12 Months
Change in PREVENT-CVD Predicted Cardiovascular Risk Score
Time frame: 12 Months
eGFR Total Slope
Time frame: 12 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 10 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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.
Patricia Wedge M Chief Operating Officer, RN, BSN, CCRC contact
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing The intervention with the MCM is Kidney-Heart GDMT initiation and titration for dose optimization (as clinically tolerated), within 4 months of enrollment in the study. in people with Chronic Kidney Disease and Type II Diabetes, run by Baim Institute for Clinical Research.
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 2 inclusion and 6 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: opening soon, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact C. Michael Gibson, MS, MD Chief Executive Officer, MS, MD (617-307-5200, info@baiminstitute.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Composite Guideline-Directed Medical Therapy (GDMT) Score (time frame: Baseline to 12 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 10 Sep 2026.