Actively Recruiting

Age: 6Years +
All Genders
Healthy Volunteers
ID03004547

Evaluation of Sodium Deposition in Soft Tissues of Patients with Kidney Disease and Its Association with Patient Symptomatology

Led by Chris McIntyre · Updated on 2025-02-12

400

Participants Needed

1

Research Sites

8 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to investigate how sodium is stored abnormally in the skin, muscle, and skeleton of people with chronic kidney disease (CKD) and related conditions. Sodium storage in these tissues can cause inflammation, which may contribute to symptoms experienced by patients. The study will compare five groups: patients on hemodialysis, patients on peritoneal dialysis, adults and children with CKD stages 1-5, patients with heart failure with or without kidney problems, and healthy people matched by age and sex. Participants will have their sodium levels measured using a special MRI scan of the lower leg. They will undergo one initial study visit and may have up to two follow-up visits, with certain tests done on non-dialysis days for hemodialysis patients. Tests include questionnaires about symptoms, physical performance tests (except for children), blood pressure and heart rate checks, blood and urine samples (except for some groups), echocardiograms (except healthy controls), and the sodium MRI scan itself. During the study, participants will be monitored for up to two years. Researchers will assess sodium content in tissues, inflammation markers like CRP, symptom scores, liver and heart markers, bone markers, uremic toxins, and endotoxin levels over varying time frames. This comprehensive evaluation aims to understand how sodium buildup relates to symptoms and biochemical changes in different patient groups.

CONDITIONS

Brief Title

Sodium Deposition in Soft Tissues of Patients with Kidney Disease

Who Can Participate

Age: 6Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age greater than or equal to 6 years
  • For patients on maintenance hemodialysis or peritoneal dialysis: more than 3 months duration of therapy
  • For patients with CKD stage 1-5: CKD stage 1-5 and no indications to start dialysis
  • For heart failure patients: with or without renal dysfunction
  • For healthy controls: no kidney disease, heart failure, liver cirrhosis, or peripheral edema
  • For follow-up visits, must have one of the following: change in dialysis prescription, change in renal replacement therapy, change in medication, parathyroidectomy, or intervention added/removed from dialysis (e.g., exercise, cooling, ischemic preconditioning)
Not Eligible

You will not qualify if you...

  • Pregnant, breastfeeding, or intending pregnancy
  • Unable to give consent or understand written information
  • Contraindication to MRI study

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - 1 day

Participants undergo a study visit including symptom questionnaires, physical function tests, blood pressure and heart rate measurements, blood and urine sampling, echocardiogram (except healthy controls), and MRI scan to measure sodium content in tissues.

1 visit (in-person)

Long-term Monitoring

Duration - Up to 2 years

Participants may have up to two additional follow-up visits on non-dialysis days if there are changes in dialysis prescription, renal therapy, medication, or related interventions. Participants will be followed for up to two years after the first study visit with periodic assessments.

Up to 3 visits over 2 years

Trial Site Locations

Total: 1 location

1

LHSC Regional Renal Care Program

London, Ontario, Canada

Actively Recruiting

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Research Team

C

Christopher W McIntyre, PhD, MD

A

Alireza Akbari, PhD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

5

Frequently Asked Questions

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