TESTING-ON: Therapeutic Evaluation of STeroids in IgA Nephropathy Global, Post-Trial ObservatioNal Cohort Study

Background

  • Immunoglobulin A Nephropathy (IgAN) is the most common type of kidney inflammation worldwide and a leading cause of kidney failure, often requiring dialysis or transplant. • 
  • The TESTING trial showed that significant kidney problems like kidney failure or a major decline in kidney function often start appearing two-to-three years after starting treatment. 
  • A post-trial observation study is a crucial and efficient way to answer key questions about whether the benefits of steroids continue over time and if lower steroid doses provide similar long-term benefits safely for kidney health.

Aims

  • To follow TESTING study participants for a longer period to see if taking methylprednisolone for six to nine months leads to lasting benefits in preventing end-stage kidney failure. 
  • To resolve persisting uncertainties regarding the use and long-term benefits of corticosteroids as a therapy for IgA nephropathy.

Methods

  • TESTING-ON is a post-trial observational study of participants randomised into the TESTING trial who are still alive, have not reached end-stage kidney failure, and did not withdraw consent during the trial. 
  • Participants will be monitored for up to five years, and possibly longer if additional funding is available.

Impact

  • Outcomes from TESTING-ON will provide the most robust evidence for clinicians on the duration and dosing of corticosteroids for IgAN patients. 
  • This evidence will help treatment providers and consumers make an informed choice about corticosteroid therapy and guide joint decision-making. 
  • TESTING-ON results will inform international guidelines on the management of IgA nephropathy.

Current  status

TESTING-ON is managed globally by The George Institute Australia. In India 68 participants are being followed up at 5 sites and in Australia 5 participants from 4 sites. Follow-up will continue for up to five years, with further ongoing follow-up should funding allow. As a post-observational study, we adopt a pragmatic approach to data collection.

Leads