TESTING -ON Post-Trial ObservatioNal Cohort Study

Recruiting

• Conditions: ESRD; Glomerulonephritis; Kidney Diseases; IgA Nephropathy

• Registration Number: NCT05434325
• Lead Sponsor: The George Institute

Brief Summary

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

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 Timeline

• Study First Submitted: 2022-06-14
• Study First Submitted QC: 2022-06-21
• Study First Posted: 2022-06-28
• Study Start: 2022-12-07
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-09
• Last Update Posted: 2025-02-11
• Primary Completion: 2027-07-30
• Study Completion: 2027-07-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 366

Inclusion Criteria

1. Only participants who were randomised into the TESTING trial

Exclusion Criteria

1. Participants who have reached kidney failure requiring maintenance dialysis or kidney transplantation during the TESTING trial
2. Participants who died during the TESTING trial
3. Participants who had withdrawn their consent during the TESTING trial
4. Participants who are unable to provide consent for some other reason

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary AIM	Through study completion, an average of 1 year	The development of end stage kidney disease (ESKD) defined as a need for maintenance dialysis or kidney transplantation, and death due to kidney disease

Secondary Outcome Measures

Name	Time	Method
Secondary Aim	Through Study Completion an average of 1 year	Time averaged proteinuria post-randomization
Secondary Aims	Through Study Complication an average of 1 Year	Annual eGFR decline rate

Trial Locations

Locations (58)

London Health Sciences Centre; 🇨🇦 London, Ontario, Canada

Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology; 🇨🇳 Wuhan, Hubei, China

The Second Hospital of Shanxi Medical University, Taiyuan; 🇨🇳 Taiyuan, Shanxi, China

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

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