Blood pressure control in patients with IgA nephropathy Urological and Genital Diseases
Conditions
Interventions
Participants will be randomized 2:1 to self-management (intervention) or usual care (comparator), carried out with a web-based randomization system. Participants in the intervention and control group
Sponsors
Ottawa Hospital Research Institute
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Adult patients aged =18 years who provide written informed consent 2. Biopsy-confirmed diagnosis of IgA nephropathy 3. Proteinuria > 0.5 g/day quantified from 24-hour urine collection or urine protein:creatinine ratio >50 mg/mmol or urine albumin:creatinine ratio >30 mg/mmol 4. Clinic systolic BP >130 mmHg or diastolic BP >85 mmHg (automated office BP measurement) 5. Willing to self-manage BP
Exclusion criteria
Exclusion criteria: 1. Currently receiving immunosuppression or in need of urgent start immunosuppression (e.g., rapidly progressive glomerulonephritis or nephrotic syndrome) 2. Kidney failure defined by the need for dialysis, kidney transplantation or eGFR 180/100 mmHg)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome of the pilot trial will be feasibility defined as achieving target threshold for both recruitment and study completion. The study protocol will be revised based on adherence metrics and participant feedback as detailed below: 1.The probability of successful recruitment will be calculated as the percentage of eligible participants who are randomized. A threshold of >50% will be required for progression to a full-scale trial. 2.The probability of retention will be calculated as the percentage of randomized patients who complete the study. A threshold of >80% will be sought for progression to a full-scale trial. 3.Adherence to the self-management protocol will be quantified for each patient in the intervention group using the median number of recorded home BP readings per measurement week. Adherence will be further explored from participant feedback in longitudinal diary entries and a semi-structured interview. There is no progression criterion for adherence but the study protocol for a future full-scale trial will be refined based on these factors. | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy outcomes will be assessed on an exploratory basis only: 1. Mean difference in achieved BP between the groups using automated office BP measurement at the end of the study period 2. Difference in systolic BP from baseline to 6-month follow-up using an automated office BP measurement 3. Difference in diastolic BP from baseline to 6-month follow-up using an automated office BP measurement 4. Difference in percentage proteinuria reduction from 24-hour between the groups using 24-hour urine collections from baseline to 6 months 5. Proportion of patients who achieve an absolute reduction in proteinuria to less than 0.5 g/day using 24-hour urine collections at the 6-month visit 6. Change from baseline in exercise (using a self-completion questionnaire), 24-hour urinary sodium excretion (using 24-hour urine collection) and waist circumference (measured at clinic visit) at the 6-month visit | — |
Countries
Canada
Contacts
Public ContactMark Canney
Outcome results
None listed