TESTING -ON Post-Trial ObservatioNal Cohort Study

Study Overview
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Brief Summary
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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).

Detailed Description
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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: Is the apparent benefit of glucocorticoid sustained over long term follow-up? 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.

Official Title
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Therapeutic Evaluation of STeroids in IgA Nephropathy Global - Post-Trial ObservatioNal Cohort Study

Conditions
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IgA Nephropathy, ESRD, Glomerulonephritis, Kidney Diseases

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1) Only participants who were randomised into the TESTING trial Exclusion Criteria Participants who have reached kidney failure requiring maintenance dialysis or kidney transplantation during the TESTING trial Participants who died during the TESTING trial Participants who had withdrawn their consent during the TESTING trial Participants who are unable to provide consent for some other reason

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| TESTING Particpants<br>All participants who were successfully randomised to the TESTING study who are still alive and have not reached kidney failure requiring dialysis. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary Aims | The composite of ESKD, 30% decrease in eGFR and all cause death | Through study completion, an average of 1 year | 
| Secondary Aims | The composite of ESKD, 40% decrease in eGFR and all cause death | Through Study completion, an average of 1 year | 
| Secondary Aims | The composite of ESKD, 50% decrease in eGFR and all cause death | Through Study Completion, an average of 1 year | 
| Secondary Aims | Each of ESKD, death due to kidney disease and all cause death | Through Study Completion, an average of 1 year | 
| Secondary Aims | Annual eGFR decline rate | Through Study Complication an average of 1 Year | 
| Secondary Aim | Time averaged proteinuria post-randomization | Through Study Completion an average of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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kidney