TESTING -ON Post-Trial ObservatioNal Cohort Study (TESTING-ON)

Therapeutic Evaluation of STeroids in IgA Nephropathy Global - 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).

Study Overview

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

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 Type: Observational
• Enrollment (Actual): 211

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Kingswood, New South Wales, Australia, 2747
      • Nepean Hospital
    • St Leonards, New South Wales, Australia, 2065
      • Royal North Shore Hospital
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • Royal Adelaide Hospital
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2R 0X7
      • University of Calgary/Alberta Health Services
    • Edmonton, Alberta, Canada, T6G 2B7
      • University of Alberta Hospitals
  • British Columbia
    • Vancouver, British Columbia, Canada, V6Z 1Y6
      • St Pauls Hospital
  • Ontario
    • Hamiliton, Ontario, Canada, L8N 4A6
      • St. Joseph's Healthcare
    • London, Ontario, Canada
      • London Health Sciences Centre
    • Toronto, Ontario, Canada, M4N 3M5
      • Sunnybrook Health Sciences Centre
    • Toronto, Ontario, Canada, M5G 2N2
      • Toronto General Hospital,
  • Quebec
    • Montreal, Quebec, Canada, H1T 2M4
      • Hôpital Maisonneuve-Rosemont
• China
  • Beijing, China
    • Peking University Third Hospital
  • Beijing, China, 100029
    • Beijing Anzhen Hospital, Capital Medical University
  • Beijing, China, 100034
    • Peking University First Hospital
  • Beijing, China, 100035
    • Peking University People's Hospital
  • Chongqing, China, 400037
    • XinQiao Hospital, Third Military Medical University
  • Shanghai, China, 200001
    • Renji Hospital, Shanghai Jiaotong University School of Medicine
  • Shanghai, China, 200025
    • Ruijin Hospital, Shanghai Jiaotong University, School of Medicine
  • Beijing Municipality
    • Beijing, Beijing Municipality, China
      • Chinese PLA General Hospital (301 Hospital)
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • The First Affiliated Hospital, Sun Yat-sen University
    • Guangzhou, Guangdong, China
      • Guangdong Provincial People's Hospital, Guangzhou
    • Shenzhen, Guangdong, China, 518036
      • Peking University Shenzhen Hospital
  • Hebei
    • Shijiazhuang, Hebei, China, 050051
      • The Third Hospital of Hebei Medical University
    • Shijiazhuang, Hebei, China, 050005
      • The Second Hospital of Hebei Medical University
  • Henan
    • Luoyang, Henan, China, 471003
      • The First Affiliated Hospital of Henan University of Science &Technology
    • Zhengzhou, Henan, China, 450052
      • The First Affiliated Hospital of Zhengzhou University
  • Hubei
    • Wuhan, Hubei, China, 430022
      • Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
    • Wuhan, Hubei, China, 430060
      • Renmin Hospital, Wuhan University
    • Wuhan, Hubei, China, 430022
      • Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology
  • Inner Mongolia
    • Baotou, Inner Mongolia, China, 014010
      • The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology,
    • Hohhot, Inner Mongolia, China, 010017
      • Inner Mongolia People's Hospital
  • Jiangsu
    • Nanjing, Jiangsu, China, 210029
      • The First Affiliated Hospital with Nanjing Medical University
  • Jilin
    • Changchun, Jilin, China, 130011
      • Jilin Province FAW General Hospital [Jilin University Fourth Hospital]
  • Liaoning
    • Dalian, Liaoning, China, 116011
      • he First Affiliated Hospital of Dalian Medical University, Dalian
    • Shengyang, Liaoning, China
      • Shengjing Hospital of China Medical University
  • Shandong
    • Jinan, Shandong, China, 250021
      • Shandong Provincial Hospital
    • Jinan, Shandong, China, 250012
      • Qilu Hospital of Shandong University
    • Jinan, Shandong, China, 250014
      • The First Affiliated Hospital of Shangdong First Medical University,Shangdong Provincial Qianfoshin
    • Jinan, Shandong, China
      • Jinan Military General Hospital
  • Shanxi
    • Taiyuan, Shanxi, China, 030001
      • The Second Hospital of Shanxi Medical University, Taiyuan
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • West China Hospital of Sichuan University
    • Chengdu, Sichuan, China, 610072
      • Sichuan Academy of Medical Science, Sichuan Provincial People's Hospital
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310003
      • The First Affiliated Hospital, Zhejiang University of Medicine
    • Hangzhou, Zhejiang, China
      • Hangzhou Hospital of Traditional Chinese Medicine,
    • Ningbo, Zhejiang, China
      • Ningbo Urology & Nephrology Hospital
    • Sangzhou, Zhejiang, China
      • Zhejiang Provincial People's Hospital
• Hong Kong
  • Kowloon
    • Kowloon, Kowloon, Hong Kong
      • Princess Margaret Hospital
• India
  • Andhra Pradesh
    • Hyderabad, Andhra Pradesh, India, 500012
      • Osmania General Hospital
    • Hyderabad, Andhra Pradesh, India, 500082
      • Nizams Institute of Medical Sciences
  • Kerala
    • Kozhikode, Kerala, India, 673008,
      • Calicut Medical College
  • Punjab
    • Chandigarh, Punjab, India, 160 012
      • Post Graduate Institue of Medical Education and Reasearch
  • Tamil Nadu
    • Chen, Tamil Nadu, India, 600037
      • Madras Medical College
• Malaysia
  • Johor
    • Johor Bahru, Johor, Malaysia, 80100
      • Hospital Sultanah Aminah
  • Kuala Lumpur
    • Kuala Lumpur, Kuala Lumpur, Malaysia, 59100
      • University Malaysia Medical Centre
  • Kulala Lumpur
    • Kuala Lumpur, Kulala Lumpur, Malaysia, 50586
      • Hospital Kuala Lumpur
  • Negri Seremban
    • Seremban, Negri Seremban, Malaysia, 70300
      • Hospital Tuanku Jaafar Seremban
  • Perak
    • Ipoh, Perak, Malaysia, 30990
      • Hospital Raja Permaisuri Bainun
  • Samarahan
    • Kuching, Samarahan, Malaysia, 93586
      • Hospital Umum Sarawak

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

The population for this study will consist of all TESTING participants who do not meet any of the exclusion criteria.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
TESTING Particpants; 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?

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

Collaborators and Investigators

• Sponsor: The George Institute
• Collaborators: Peking University Institute of Nephrology
• Investigators: Study Chair: Hong Zhang, Prof, Peking University Institute of Nephrology; Study Chair: Vlado Perkovic, Prof, University of New South Wales; Principal Investigator: Muh Geot Wong, Dr, University of New Souht Wales; Principal Investigator: Jicheng Lv, Peking University of Nephrology

Study record dates

Study Major Dates

• Study Start (Actual): December 7, 2022
• Primary Completion (Actual): July 17, 2025
• Study Completion (Actual): August 30, 2025

Study Registration Dates

• First Submitted: June 14, 2022
• First Submitted That Met QC Criteria: June 21, 2022
• First Posted (Actual): June 28, 2022

Study Record Updates

• Last Update Posted (Actual): June 11, 2026
• Last Update Submitted That Met QC Criteria: June 9, 2026
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: kidney
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Autoimmune Diseases; Immune System Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Nephritis; Pathological Conditions, Signs and Symptoms; Glomerulonephritis; Kidney Diseases; Kidney Failure, Chronic; Glomerulonephritis, IGA
• Other Study ID Numbers: TESTING-ON

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No