Screening for Chronic Kidney Disease

Overseen By David Collister, MD, PhD, FRCPC

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Manitoba

Disqualifiers: Kidney failure, Chronic kidney disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 5 years

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the best way to screen for chronic kidney disease (CKD) in First Nations adults in Manitoba. It aims to identify individuals with CKD, assess their risk of kidney failure, and initiate treatments to prevent disease progression. Participants will be divided into two groups: one will receive a letter with lab test instructions, and the other will receive a letter without instructions. This trial suits First Nations adults in Manitoba who haven't been screened for CKD in the past two years. Participants will undergo a Virtual Kidney Check and Follow-up, a method for remotely monitoring kidney health. As an unphased trial, this study offers a unique opportunity to contribute to important research that could enhance CKD screening and prevention for First Nations communities.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that this screening method is safe for First Nations adults in Manitoba?

Research has shown that virtual check-ups for chronic kidney disease (CKD) are generally safe. One study found that virtual follow-ups can reduce emergency room visits and hospital stays for CKD patients, indicating that this method is well-tolerated. Another project, CKD Safety Net, provides timely monitoring and treatment to help prevent the sudden need for dialysis. These efforts demonstrate a safe and scalable way to manage CKD.

In summary, virtual kidney check-ups and follow-ups appear safe and helpful for those at risk of CKD, with no major safety concerns reported so far. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative ways to screen for chronic kidney disease (CKD) using virtual methods. Unlike traditional screenings that require in-person visits, one approach uses mail contact with a laboratory requisition, allowing patients to conveniently conduct necessary tests for serum creatinine and urine albumin-to-creatinine ratio from home. Another approach involves mailing contact without a lab requisition, aiming to engage both patients and their primary care networks, potentially increasing awareness and early detection. These methods could make CKD screening more accessible and improve early diagnosis rates, which is crucial for effective management of the disease.

What evidence suggests that this trial's methods could be effective for screening chronic kidney disease?

Research shows that virtual check-ups and online health programs can help manage chronic kidney disease (CKD). Studies have found that these methods can lead to better eating habits, improved quality of life, and healthier kidney function in adults with CKD. Additionally, virtual check-ups can reduce emergency room visits and hospital stays for people with advanced CKD. In this trial, the Virtual Kidney Check and Follow-up program focuses on early detection and monitoring of CKD, which is crucial to prevent disease progression. This approach aims to identify at-risk patients and provide timely assistance to manage their condition. Participants will receive either patient contact via mail with a letter and laboratory requisition or patient and primary care network contact via mail with a letter but no laboratory requisition. ^{1 3 6 7 8}

Who Is on the Research Team?

David Collister, MD, PhD, FRCPC

Principal Investigator

University of Manitoba

Are You a Good Fit for This Trial?

This trial is for First Nations adults living in Manitoba who are at least 18 years old. It's designed to help those from any urban, rural, or remote location. The study aims to find the best way to screen and manage chronic kidney disease (CKD) within this population.

Inclusion Criteria

Urban, rural or remote location

Resident of Manitoba

First Nations

Exclusion Criteria

Screening for chronic kidney disease with estimated Glomerular Filtration Rate or Albumin to Creatinine ratio in the last 2 years

I am on dialysis or have had a kidney transplant.

I have chronic kidney disease with low kidney function for over 3 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

6 months

Virtual and mail-based contact

Treatment

Participants receive treatments to prevent the progression of chronic kidney disease, including mineral corticoid receptor antagonists, SGLT2 inhibitors, and other therapies

5 years

Follow-up

Participants are monitored for safety and effectiveness after treatment, including tracking changes in estimated Glomerular Filtration Rate and other health outcomes

5 years

What Are the Treatments Tested in This Trial?

Interventions

• Virtual Kidney Check and Follow-up

Trial Overview The trial tests two methods of inviting participants for CKD screening: one group receives a mail letter with lab requests for specific tests, while the other gets just a letter without lab requests. The goal is to see which method leads more people to get screened within six months.

How Is the Trial Designed?

Group I: Patient contact via mail with a letter and laboratory requisition Experimental Treatment 1 Intervention

Patient contact via mail with a letter and laboratory requisition for serum creatinine and urine albumin to creatinine ratio

Group II: Patient and primary care network contact via mail with a letter but no laboratory requisition Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

University of Manitoba

Lead Sponsor

Trials

628

Recruited

209,000+

Manitoba Health, Seniors and Long-Term Care, Province of Manitoba

Collaborator

Trials

1

Recruited

3,400+

Seven Oaks General Hospital

Collaborator

Trials

2

Recruited

3,400+

Boehringer Ingelheim

Industry Sponsor

Trials

2,566

Recruited

16,150,000+

First Nations Health and Social Secretariat of Manitoba

Collaborator

Trials

2

Recruited

5,900+

Shared Health Manitoba

Collaborator

Trials

1

Recruited

3,400+

Research Manitoba

Collaborator

Trials

13

Recruited

17,500+

Published Research Related to This Trial

The National Kidney Foundation's Kidney Early Evaluation Program (KEEP) effectively identifies chronic kidney disease (CKD) in high-risk populations, with 28.7% of the 100,000 participants screened found to have CKD, compared to a lower prevalence of 13.1% reported in the general population.

KEEP's structured screening approach not only detects CKD early but also enhances understanding of kidney disease, supporting public health initiatives aimed at improving outcomes for individuals with diabetes, hypertension, or a family history of these conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Screening populations at increased risk of CKD: the Kidney Early Evaluation Program (KEEP) and the public health problem. Vassalotti, JA., Li, S., Chen, SC., et al.[2022]

In a study of 267 predialysis patients with chronic kidney disease (CKD), 69.3% experienced at least one adverse safety event, highlighting the high risk of complications in this population.

The most common adverse events reported were hypoglycemia in diabetic patients and hyperkalemia (high potassium levels), with significant co-occurrences of these events, indicating a need for better safety monitoring in CKD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-reported and actionable safety events in CKD. Ginsberg, JS., Zhan, M., Diamantidis, CJ., et al.[2021]

Chronic kidney disease (CKD) patients face a high risk of adverse safety events due to factors like impaired kidney function and polypharmacy, which can lead to serious outcomes such as hospitalization and accelerated kidney function loss.

Telemedicine, particularly through interactive voice-response systems, offers a promising way for CKD patients to communicate safety-related issues to healthcare providers, although many patients face challenges in accessing these technologies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telemedicine to Promote Patient Safety: Use of Phone-Based Interactive Voice-Response System to Reduce Adverse Safety Events in Pre-dialysis CKD. Weiner, S., Fink, JC.[2022]

In a study of 64 patients using live interactive telenephrology, 31.2% had their treatment plans changed compared to what their referring health provider suggested, indicating effective diagnosis and management of kidney diseases.

Patients reported significant improvements in their quality of life, with SF8 scores increasing from 33.1 to 45.0 after 2 months, alongside high satisfaction rates due to reduced waiting times and costs associated with teleconsultations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telenephrology application in rural and remote areas of Jordan: benefits and impact on quality of life. AlAzab, R., Khader, Y.[2016]

In a 6-month study involving 52 Stage III-V CKD patients, the interactive voice-inquiry dial-response system (IVRDS) detected significantly more adverse safety events (54% of participants) compared to a paper diary (15%), highlighting its effectiveness in monitoring patient-reported outcomes.

The IVRDS not only identified a higher rate of clinically significant events, such as hypoglycemia, but also received positive feedback from participants, suggesting it could enhance patient safety in chronic kidney disease management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-Reported Safety Events in Chronic Kidney Disease Recorded With an Interactive Voice-Inquiry Dial-Response System: Monthly Report Analysis. Fink, JC., Doerfler, RM., Yoffe, MR., et al.[2023]

A pilot trial involving 52 patients with advanced chronic kidney disease (CKD) tested the feasibility of using online electronic patient-reported outcome measures (ePROMs) for real-time symptom monitoring, showing high retention (96%) and adherence (74% at 180 days).

The ePROM intervention was well-accepted by patients, indicating potential for improving patient engagement in managing CKD, although strategies are needed to maintain long-term participation beyond 270 days.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Results of a pilot feasibility randomised controlled trial exploring the use of an electronic patient-reported outcome measure in the management of UK patients with advanced chronic kidney disease. Kyte, D., Anderson, N., Bishop, J., et al.[2022]

The virtual CKD clinic (VC) effectively monitored patients with chronic kidney disease (CKD) without any patients requiring emergency dialysis, indicating strong surveillance and management of the condition.

Survival rates for patients monitored through the VC were comparable to those of CKD patients who were discharged to primary care, suggesting that the VC is a viable alternative for managing CKD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A virtual clinic to improve long-term outcomes in chronic kidney disease. Harnett, P., Jones, M., Almond, M., et al.[2020]

In a 1-year study involving 182 outpatients with advanced chronic kidney disease (CKD), the eKidneyCare app significantly reduced medication discrepancies compared to the MyMedRec app, indicating better medication management.

eKidneyCare not only lowered the total number of discrepancies but also reduced the severity of clinically relevant discrepancies, including those that could potentially cause serious harm, highlighting its effectiveness in improving medication safety for high-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital Applications Targeting Medication Safety in Ambulatory High-Risk CKD Patients: Randomized Controlled Clinical Trial. Ong, SW., Jassal, SV., Porter, EC., et al.[2023]

Citations

1. ctv.veeva.com ctv.veeva.com/study/virtual-kidney-check-and-follow-up

Virtual Kidney Check and Follow-up - ClinicalTrials.Veeva The goal of this clinical trial is to determine the most effective way to complete population-based screening for chronic kidney disease ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11975977/

The Effectiveness of Telehealth Intervention on Chronic ... To evaluate the effectiveness of telehealth programs on dietary habits, quality of life, renal function, and blood pressure in adults with chronic kidney ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12497972/

A Pragmatic Randomized Controlled Trial of a CKD-Specific ... This study will help determine whether virtual monitoring in advanced CKD patients can reduce ED visits and hospitalization. Trial registration:.

4. withpower.com withpower.com/trial/phase-renal-insufficiency-chronic-3-2024-c57a4

Screening for Chronic Kidney Disease · Info for Participants The Virtual Kidney Check and Follow-up treatment is unique because it focuses on early detection and monitoring of chronic kidney disease through virtual means, ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04094831

Community-based Screening of Chronic Kidney Disease ( ... A community based randomized controlled effectiveness trial (RCT) Study site: DSS area of Mirzapur sub-district under Tangail, Bangladesh. Outcome measures:.

6. cansolveckd.ca cansolveckd.ca/research-projects/safe-ckd-designing-and-implementing-a-safety-net-surveillance-program-for-high-risk-ckd/

CKD Safety Net By offering timely follow-up and treatment, the project aims to improve outcomes, reduce unplanned dialysis starts, and demonstrate a scalable model for ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT03847766

Follow-up Using Patient-Reported Outcome (PRO ... The aim of this study is to compare the effect on the clinical outcomes, the utilisation of resources, and patient-reported outcome in three types of follow-up ...

8. jamanetwork.com jamanetwork.com/journals/jamainternalmedicine/fullarticle/2817606

Electronic Health Record Population Health Management ... This cluster randomized clinical trial examines the effectiveness of an electronic health record–based population health management ...