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NCT Number: NCT05434325

TESTING -ON Post-Trial ObservatioNal Cohort Study

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).

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Key information

Conditions

IgA Nephropathy Autoimmune Diseases Chronic Disease Disease Attributes ESRD Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glomerulonephritis Glomerulonephritis, IGA Immune System Diseases Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Nephritis Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Concord Repatriation General Hospital, Concord W., New South Wales, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. Primary AIM

    Time frame: 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 outcomes

  1. Secondary Aims

    Time frame: Through study completion, an average of 1 year

    The composite of ESKD, 30% decrease in eGFR and all cause death

  2. Secondary Aims

    Time frame: Through Study completion, an average of 1 year

    The composite of ESKD, 40% decrease in eGFR and all cause death

  3. Secondary Aims

    Time frame: Through Study Completion, an average of 1 year

    The composite of ESKD, 50% decrease in eGFR and all cause death

  4. Secondary Aims

    Time frame: Through Study Completion, an average of 1 year

    Each of ESKD, death due to kidney disease and all cause death

  5. Secondary Aims

    Time frame: Through Study Complication an average of 1 Year

    Annual eGFR decline rate

  6. Secondary Aim

    Time frame: Through Study Completion an average of 1 year

    Time averaged proteinuria post-randomization

Sponsors and collaborators

Lead sponsor

The George Institute

Other

Collaborators

  • Peking University Institute of Nephrology

Registry information

Official study title

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

Acronym: TESTING-ON

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jun 28, 2022
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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