Supported Research

Co-Applicant(s):  Ayub Akbari, Brendan McCormick, Caitlin Hesketh, David Massicotte-Azarniouch, Grace Fox, Sean Barbour, Stuart Nicholls, Todd Fairhead

Lay Abstract

Can self-management of blood pressure lead to better kidney outcomes for patients with IgA nephropathy? Background IgA nephropathy is a kidney condition in which an imbalance in the patient’s immune system causes injury to the tiny filters within their kidneys leading to leakage of protein and blood into the urine, and decreased kidney function. Because IgA nephropathy tends to occur when patients are young, they have a high risk of developing kidney failure over their lifetime. Controlling blood pressure (BP) can protect their kidney filters from further injury. When done well, this treatment can help reduce the amount of protein in the urine (the best marker of kidney damage) and preserve kidney function, sometimes avoiding the need for more toxic immune-suppressing drugs. Despite the importance of BP control, there is no accepted standard for how BP should be measured and treated in patients with IgA nephropathy. By checking BP only at the time of kidney clinic visits, there are missed opportunities to detect and treat high BP appropriately. Purpose This study aims to test whether patients with IgA nephropathy who self-manage their BP will have better BP control and less protein in their urine compared to patients whose BP is measured and treated only at kidney clinic visits. Method Self-management means that patients measure their BP at home and adjust the dose of their medications to a target BP value. A previous clinical trial conducted in patients without kidney disease showed that patients and their family doctors were able to successfully develop a self-management protocol. The first step in this study is to adapt that protocol for patients with IgA nephropathy. We will work directly with patient partners during a series of monthly meetings to refine the self-management protocol to ensure that it is acceptable, safe and easy to follow. After that, we will ask patient partners to test out the protocol and provide feedback about every part of the process. Once we have finalized the self-management protocol, we will conduct a pilot clinical trial involving 20-25 patients with IgA nephropathy who attend kidney clinics in Ottawa and Vancouver. Trial participants will be randomly chosen to either manage their BP using the self-management protocol or to be in the control group. Participants in the self-management group will contact the research team each month with their home BP values to have their medications adjusted without the need for a clinic visit with their doctor. Participants in the control group will have their BP measured and treated at clinic visits only. All participants will be followed for 6 months. At the start of the study and again after 6 months, participants’ urine protein levels will be measured using a 24-hour urine collection and their BP will be measured using a 24-hour monitor. Blood tests will be done each time the dose of BP medications is increased for monitoring of kidney function and potassium levels. Anticipated outcomes The main outcome of the pilot trial is to find out if patients with IgA nephropathy will be willing to enter a trial of self-management of BP and to ensure that the protocol can be implemented safely and is not overly burdensome. The trial will also get preliminary information about whether self-management leads to better BP control and less protein in the urine. Patient engagement Patients will be involved in every stage of this study from its design all the way through to completion of the pilot trial and sharing of the results. Relevance to patients and the kidney community Patients living with IgA nephropathy have told us that their number one priority is preserving their kidney health and they would like to have more control over managing their condition. By developing an intervention with patients that can be implemented at home, this study seeks to meet both of these needs. Protein in the urine is a strong risk factor for kidney failure and heart disease. If shown to be successful, a self-management approach could improve the long-term health of patients with IgA nephropathy and reduce healthcare costs. Conclusion Good control of BP is critical to reduce the risk of kidney failure in patients with IgA nephropathy. What is learned from this pilot trial will be used to design a larger trial to answer the question of whether self-management of BP should be first choice in how to manage BP in patients with IgA nephropathy.