AzTrials
AzTrials

Diabetic Kidney DiseaseRX4DKDNCT07169422

Improving Kidney Care in Type 2 Diabetes: A Study of Pharmacist Prescribing Versus Usual Care

A study testing Pharmacist-led validated diabetic kidney disease decision support algorithm. in people with Diabetic Kidney Disease and Type 2 Diabetes, run by Nova Scotia Health Authority at 1 site in Canada.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Pharmacist-led validated diabetic kidney disease decision support algorithm.
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
120 participants
Where
1 siteCanada
Study dates
1 Mar 2026to 1 Jul 2028
Phase
Interventional
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

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jo-Anne Wilson, BSc Pharm, ACPR, MEd, PharmD contact

9024886623

Jo-Anne.wilson@dal.ca

Laura Sills, RN, BSN contact

+1-(289)-201-4175

Laura.Sillis@nshelath.ca

Canada1 site, 1 recruiting
  • Dalhousie University

    Halifax, Nova Scotia, b3h 2y9

    Jo-Anne Wilson, 9024886623, jo-anne.wilson@dal.ca

    Recruiting

Other trials in Canada

About this study

Official title: Community Pharmacist Prescription for Diabetic Kidney Disease (Rx4DKD): A Randomized Controlled Trial and Implementation Study

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.

Read the detailed description

Importance: Diabetes is the leading cause of kidney disease. However, the use of guideline directed medical treatments (GDMT) to slow kidney disease progression and reduce the risk of heart disease remains suboptimal. Health system solutions are urgently needed to optimize treatment for individuals with diabetic kidney disease (DKD). Since 2023, the government of Nova Scotia launched 46 community pharmacist-led primary care clinics (CPPCCs) in medically under served areas and expanded the pharmacist's scope of practice to include medication prescribing, either independently or in virtual consultation with another prescriber. In collaboration with regulatory authorities, the investigators developed and validated algorithms focused on GDMT for DKD to support community pharmacists in its management. As part of the initial implementation, the prescribing algorithms will be integrated into a digital health application familiar to pharmacists delivering care in pharmacy primary care clinics. Herein, the investigators propose a hybrid type 1 effectiveness-implementation study to determine if the pharmacist-led prescription algorithms improve the use of GDMT in pharmacy primary care clinics compared to usual care provided through a walk-in or mobile health clinic or virtual care.

Objectives: This feasibility pilot RCT specifically seeks to: 1) Examine the feasibility of implementing the pharmacist-led prescription algorithms for DKD GDMT based on the number of individuals newly initiated and adherent to at least one of renin-angiotensin system inhibitors (RASi), sodium glucose cotransporter-2 inhibitors (SGLT2i) and nonsteroidal mineralocorticoid receptor antagonists (nsMRA) at the end of the study; 2) Determine the feasibility of conducting a pivotal RCT of the pharmacist-led prescription algorithms versus usual care based on recruitment rates and loss to follow up; and 3) Identify barriers and facilitators to the implementation of the pharmacist-led prescription algorithms in CPPCCs.

Research Plan: The investigators propose a hybrid type 1 design, combining an open-label parallel-group randomized controlled trial of 120 participants to test the feasibility of implementing pharmacist-led GDMT prescribing algorithms versus usual care. There will be up to 46 CPPCCs participating in the trial, all of which will be trained to use the validated algorithms. Potential participants will be recruited over 12 months from a centralized registry maintained by the Diabetes Care Program Nova Scotia which includes a list of patients with diabetes not rostered to a family physician. From the registry, individuals identified as having T2D will be invited to participate and those agreeing to participate will undergo screening lab tests performed at a pharmacy clinic to collaboratively establish a new diagnosis or confirm a pre-existing diagnosis of DKD (eGFR < 60 ml/min/1.73m2 and or UACR > 3 mg/mmol, persistence for at least 3 months).

Eligible participants will be randomized 1:1 to immediate enrolment with a community pharmacy clinic (intervention group) versus usual care (control group) and followed for 12 months. Barriers and facilitators will be identified through an electronic survey administered to pharmacist participants to capture both individual-level factors and environmental/contextual factors affecting implementation. The outcome measures will be summarized using counts and percentages and compared using chi-square test. Logistic regression will be used to report odds ratio and 95% confidence interval. Additional multivariable models will look at the association between sex, gender, race and ethnicity with adherence rate.

Our primary hypothesis is that there will be a greater than 30% increase in the number of people on at least one new GDMT (RASi, SGLT2i, nsMRA) for DKD at 12 months using the provincial medication database.

Secondary hypotheses include: 1) more than 30% of participants meeting eligibility criteria will undergo consent and randomization; and 2) participant loss to follow-up rate of <10% for study duration.

Study Significance: Population level interventions are needed to improve use of beneficial guideline-directed medical treatments. Validated pharmacist-led prescription algorithms offers an approach to improve DKD health care delivery and coordination of care.

Being tested
Usual care for diabetic kidney disease management without primary care provider., Pharmacist-led validated diabetic kidney disease decision support algorithm.
Keywords
diabetic kidney disease, pharmacist-led prescribing, type 2 diabetes, guideline directed medical treatments, pharmacy care models, decision support algorithym, chronic kidney disease
Medical subject headings
Diabetic Nephropathies, Diabetes Mellitus, Type 2, Renal Insufficiency, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Usual care for diabetic kidney disease management without primary care provider.Other

    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-led validated diabetic kidney disease decision support algorithm.Other

    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).

Study groups in NCT07169422
Study groupRoleWhat they receive
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.
Receives: Other: Pharmacist-led validated diabetic kidney disease decision support algorithm.
Arm 2 ( control group)Placebo comparatorParticipants will continue with usual care through, walk-in or mobile clinics for their diabetic kidney disease care.
Receives: Other: Usual care for diabetic kidney disease management without primary care provider.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: From randomization to the end of follow-up period at 12 months.

  2. 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.

    Measured: From randomization to the end of the follow-up period at 12 months.

Secondary outcomes (3)
  1. Effectiveness of Community Pharmacist-Led Prescribing Algorithms to Improve Guideline-Directed Medical Therapy Use in Diabetic Kidney Disease: The Rx4DKD Randomized Controlled Trial

    1. Number of participants who meet eligibility criteria after screening who do not consent to participate.

    Measured: At baseline

  2. Effectiveness of Community Pharmacy-Led Prescribing Algorithms to Improve Guideline-Directed Medical Therapy Use in Diabetic Kidney Disease: The Rx4DKD Randomized Controlled Trial.

    Number of consenting participants who are lost to follow-up at 12 months.

    Measured: From randomization to end of follow-up period at 12 months.

  3. Effectiveness of Community Pharmacist-Led Prescribing Algorithms to Improve Guideline-Directed Medical Therapy Use in Diabetic Kidney Disease: The Rx4DKD Randomized Controlled Trial

    Barriers and Facilitators using an electronic survey developed utilizing the theoretical domains framework will capture individual-level factors and environmental/contextual factors affecting implementation.

    Measured: From randomization to end of follow-up perio at 12 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Sep 2025
  2. Study start1 Mar 2026 (estimated)
  3. Primary completion1 Jan 2028 (estimated)
  4. Study completion1 Jul 2028 (estimated)

Resources

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 N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is a type-1 hybrid effectiveness-implementation study, combining a open-label parallel-group, randomized controlled trial with a subsequent process evaluation.
Masking
None (open label)
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07169422
Sponsor's protocol ID
RX4DKD
Acronym
RX4DKD
Status last verified
Mar 2026
First submitted
30 Aug 2025
Last updated
18 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Pharmacist-led validated diabetic kidney disease decision support algorithm. in people with Diabetic Kidney Disease and Type 2 Diabetes, run by Nova Scotia Health Authority at 1 site in Canada.

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 3 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 18 Mar 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 Canada. 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. Some participants in this study may receive a placebo. 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?

Contact Jo-Anne Wilson, BSc Pharm, ACPR, MEd, PharmD (9024886623, Jo-Anne.wilson@dal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Effectiveness of Community Pharmacist-Led Prescribing Algorithms to Improve Guideline-Directed Medical Therapy Use in Diabetic Kidney Disease: The Rx4DKD Randomized Controlled Trial (time frame: From randomization to the end of follow-up period at 12 months.). The study lists 2 primary outcomes in all. 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 18 Mar 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in