Improving Kidney Care in Type 2 Diabetes: A Study of Pharmacist Prescribing Versus Usual Care
RX4DKD
Community Pharmacist Prescription for Diabetic Kidney Disease (Rx4DKD): A Randomized Controlled Trial and Implementation Study
1 other identifier
interventional
120
1 country
1
Brief Summary
Type 2 diabetes is the leading cause of chronic kidney disease, which can result in serious complications such as kidney failure and heart disease. Although effective medications exist to slow the progression of kidney damage, they are often underused in primary care, particularly for individuals without a regular family doctor. In response to this gap, 46 community pharmacy-led primary care clinics were launched across Nova Scotia in 2023 to serve under-resourced areas. Pharmacists at these clinics can prescribe for many chronic conditions, but currently not for diabetic kidney disease. To address this, the research team collaborated with kidney, diabetes, and primary care experts, patient partners and regulatory bodies to develop and validate step-by-step prescribing guide (called algorithms) that support pharmacists in identifying and managing diabetic kidney disease. All medications included are approved, publicly funded in Nova Scotia, target people with earlier categories of diabetic kidney disease and includebuilt-in safety monitoring, nurse practitioner consultation or referral to a kidney doctor. This study will evaluate whether these algorithms improve kidney protective medication use which have shown to be beneficial for people with diabetes and kidney disease. The investigators will recruit 120 adults with type 2 diabetes from a provincial diabetes registry who do not have a primary care provider and screen them at pharmacy clinics for diabetic kidney disease. Those eligible and who wish to participate will be randomly assigned to either an intervention group receiving pharmacist-led care using the algorithms or a control group receiving usual care through walk-in, mobile, or virtual clinics. The investigators will measure how many patients begin and continue recommended medications, as well as any medication-related side effects or hospitalizations. Pharmacist participants will also complete a survey to identify what helps or hinders implementation in real-world practice. This research is relevant because it aims to expand access to kidney-protective treatments for people with diabetes, especially those with early forms of diabetic kidney disease who do not have regular access to primary care provider, ultimately improving long-term health outcomes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2026
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 30, 2025
CompletedFirst Posted
Study publicly available on registry
September 11, 2025
CompletedStudy Start
First participant enrolled
March 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2028
March 18, 2026
March 1, 2026
1.8 years
August 30, 2025
March 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Effectiveness of Community Pharmacist-Led Prescribing Algorithms to Improve Guideline-Directed Medical Therapy Use in Diabetic Kidney Disease: The Rx4DKD Randomized Controlled Trial
Number of participants newly initiated on and adherent to a least one of RASi, SGLT2i and nsMRA at 12 months will be calculated for the pharmacist-led community pharmacy primary care clinic using the intervention (validated diabetic kidney disease prescribing algorithms) compared to usual care for people without a family doctor (eg. virtual care, walk-in clinic).
From randomization to the end of follow-up period at 12 months.
Effectiveness of Community Pharmacist-Led Prescribing Algorithms to Improve Guideline-Directed Medical Therapy Use in Diabetic Kidney Disease: The Rx4DKD Randomized Controlled Trial
The number of participants who discontinue use of any newly initiated RASi, SGLT2i, nsRMA during the study follow-up period due to a treatment-related adverse event (specifically hyperkalemia, acute changes in serum creatinine or hypotension) will be calculated.
From randomization to the end of the follow-up period at 12 months.
Secondary Outcomes (3)
Effectiveness of Community Pharmacist-Led Prescribing Algorithms to Improve Guideline-Directed Medical Therapy Use in Diabetic Kidney Disease: The Rx4DKD Randomized Controlled Trial
At baseline
Effectiveness of Community Pharmacy-Led Prescribing Algorithms to Improve Guideline-Directed Medical Therapy Use in Diabetic Kidney Disease: The Rx4DKD Randomized Controlled Trial.
From randomization to end of follow-up period at 12 months.
Effectiveness of Community Pharmacist-Led Prescribing Algorithms to Improve Guideline-Directed Medical Therapy Use in Diabetic Kidney Disease: The Rx4DKD Randomized Controlled Trial
From randomization to end of follow-up perio at 12 months.
Study Arms (2)
Arm 1 ( Intervention group)
ACTIVE COMPARATORParticipants will receive ongoing clinical care from a community pharmacy primary care clinic, with pharmacists managing diabetic kidney disease using validated prescription algorithms.
Arm 2 ( control group)
PLACEBO COMPARATORParticipants will continue with usual care through, walk-in or mobile clinics for their diabetic kidney disease care.
Interventions
Participants in the control group will receive usual care for diabetic kidney disease which includes virtual care, walk-in clinics, or mobile health clinics for people without a primary care provider.
Pharmacist working in community pharmacy primary care clinic in Nova Scotia will utilize previously validated diabetic kidney disease decision support algorithms for renin-angiotensin system inhibitors (RASi), sodium-glucose co-transporter 2 inhibitors (SGLT2i), or nonsteroidal mineralocorticoid receptor antagonists (nsMRA).
Eligibility Criteria
You may qualify if:
- Adults ≥18 years with T2D and DKD (eGFR≥ 30-60 ml/min/1.73m2 and/or UACR≥3 mg/mmol)
- Adults who do not have primary care provider,
- Adults who are eligible for initiation of treatment with RASi, SGLT2i or nsMRA
You may not qualify if:
- Hypotension
- Type 1 diabetes
- History of allergy or intolerance to either, renin angiotensin system inhibitor (RASi), SGLT2 inhibitor (SGLT2i) and nonsteroidal mineralocorticoid receptor antagonist (nsMRA).
- Already receiving all three medications: RASi, SGLT2i, and nsMRA .
- Exceed algorithm thresholds for potassium levels or eGFR less than 30 mL/min/1.73m²
- Limited life expectancy of less than 1 year
- Followed by a subspecialty physician (e.g., nephrologist or endocrinologist)
- Unable to give consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dalhousie University
Halifax, Nova Scotia, b3h 2y9, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor, Pharmacy, Faculty of Health, College of Pharmacy, Dalhousie University; Scientific Affiliate, Nova Scotia Health Research and Innovation, Associate Scientist, MSSU
Study Record Dates
First Submitted
August 30, 2025
First Posted
September 11, 2025
Study Start
March 1, 2026
Primary Completion (Estimated)
January 1, 2028
Study Completion (Estimated)
July 1, 2028
Last Updated
March 18, 2026
Record last verified: 2026-03