The primary aim of this study is to extend follow up of TESTING study participants and to assess the long-term effects of a 6-9-month course of oral methylprednisolone on End Stage Kidney Disease (ESKD), according to dose (full-dose vs reduced-dose), ethnicity (Chinese vs other) and kidney function (eGFR above and below 60 mL/min/1.73m2).
In the original TESTING study, the median follow-up for full vs reduced dose cohort was 6.1 vs 2.5 years. We learned from the TESTING trial that the composite endpoints (ESKD, 40% reduction in eGFR or death due to kidney disease) tend to start occurring 2-3 years after randomization. At the time of overall study completion, most of the reported endpoints had occurred in participants from the initial, full-dose TESTING cohort. Although we found the effect of corticosteroid is consistent in both doses, longer follow up is required to confirm the beneficial effects on clinically important renal outcomes of the apparently safer reduced reduced-dose cohort, and to confidently compare the effects across doses. As the trial is assessing the effects of a time-limited 6-9-month period of steroids, a post-trial observation cohort study is a critical, cost and resource-efficient method of answering a number of key questions: 1. Is the apparent benefit of glucocorticoid sustained over long term follow-up? 2. Does a lower dose of steroids safely produce similar benefits on long-term kidney outcomes? The primary aim of TESTING-ON is to extend follow up of TESTING study participants and to assess the long-term effects of a 6-9-month course of oral methylprednisolone on end stage kidney disease (ESKD), according to dose (full-dose vs reduced-dose), ethnicity (Chinese vs other) and kidney function (eGFR above and below 60 mL/min/1.73m2). The working hypothesis of TESTING-ON is that a 6-9-month course of oral methylprednisolone will lead to persistent benefits over a long period of time. TESTING-ON is a post-trial observational study of those participants randomized into the TESTING trial who are still alive, haven't reached ESKD and didn't withdraw consent during the trial. Follow-up will continue for up to five years, with further ongoing follow-up should funding allow.
Study Type
OBSERVATIONAL
Enrollment
211
Primary AIM
The development of end stage kidney disease (ESKD) defined as a need for maintenance dialysis or kidney transplantation, and death due to kidney disease
Time frame: Through study completion, an average of 1 year
Secondary Aims
The composite of ESKD, 30% decrease in eGFR and all cause death
Time frame: Through study completion, an average of 1 year
Secondary Aims
The composite of ESKD, 40% decrease in eGFR and all cause death
Time frame: Through Study completion, an average of 1 year
Secondary Aims
The composite of ESKD, 50% decrease in eGFR and all cause death
Time frame: Through Study Completion, an average of 1 year
Secondary Aims
Each of ESKD, death due to kidney disease and all cause death
Time frame: Through Study Completion, an average of 1 year
Secondary Aims
Annual eGFR decline rate
Time frame: Through Study Complication an average of 1 Year
Secondary Aim
Time averaged proteinuria post-randomization
Time frame: Through Study Completion an average of 1 year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Concord Repatriation General Hospital
Concord W., New South Wales, Australia
Nepean Hospital
Kingswood, New South Wales, Australia
Royal North Shore Hospital
St Leonards, New South Wales, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
University of Calgary/Alberta Health Services
Calgary, Alberta, Canada
University of Alberta Hospitals
Edmonton, Alberta, Canada
St Pauls Hospital
Vancouver, British Columbia, Canada
St. Joseph's Healthcare
Hamiliton, Ontario, Canada
London Health Sciences Centre
London, Ontario, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
...and 49 more locations