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IgA NephropathyTESTING-ONNCT05434325

TESTING -ON Post-Trial ObservatioNal Cohort Study

An observational study of IgA Nephropathy and ESRD, run by The George Institute at 59 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
IgA Nephropathy, ESRD, Glomerulonephritis
How many people
211 participants
Where
59 sitesin 6 countries
Study dates
7 Dec 2022to 30 Aug 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 1) Only participants who were randomised into the TESTING trial

Who cannot join

  • 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  • Participants who had withdrawn their consent during the TESTING trial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

Trial locations and contacts

59 sites in 6 countries.

59 sites in 6 countries

China35 sites

  • The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology,

    Baotou, Inner Mongolia, 014010

  • Chinese PLA General Hospital (301 Hospital)

    Beijing, Beijing Municipality

  • Beijing Anzhen Hospital, Capital Medical University

    Beijing, 100029

  • Peking University First Hospital

    Beijing, 100034

  • Peking University People's Hospital

    Beijing, 100035

  • Peking University Third Hospital

    Beijing

  • Jilin Province FAW General Hospital [Jilin University Fourth Hospital]

    Changchun, Jilin, 130011

  • West China Hospital of Sichuan University

    Chengdu, Sichuan, 610041

  • Sichuan Academy of Medical Science, Sichuan Provincial People's Hospital

    Chengdu, Sichuan, 610072

  • XinQiao Hospital, Third Military Medical University

    Chongqing, 400037

  • he First Affiliated Hospital of Dalian Medical University, Dalian

    Dalian, Liaoning, 116011

  • The First Affiliated Hospital, Sun Yat-Sen University

    Guangzhou, Guangdong, 510080

  • Guangdong Provincial People's Hospital, Guangzhou

    Guangzhou, Guangdong

  • The First Affiliated Hospital, Zhejiang University of Medicine

    Hangzhou, Zhejiang, 310003

  • Hangzhou Hospital of Traditional Chinese Medicine,

    Hangzhou, Zhejiang

  • Inner Mongolia People's Hospital

    Hohhot, Inner Mongolia, 010017

  • Qilu Hospital of Shandong University

    Jinan, Shandong, 250012

  • The First Affiliated Hospital of Shangdong First Medical University,Shangdong Provincial Qianfoshin

    Jinan, Shandong, 250014

  • Shandong Provincial Hospital

    Jinan, Shandong, 250021

  • Jinan Military General Hospital

    Jinan, Shandong

  • The First Affiliated Hospital of Henan University of Science &Technology

    Luoyang, Henan, 471003

  • The First Affiliated Hospital with Nanjing Medical University

    Nanjing, Jiangsu, 210029

  • Ningbo Urology & Nephrology Hospital

    Ningbo, Zhejiang

  • Zhejiang Provincial People's Hospital

    Sangzhou, Zhejiang

  • Renji Hospital, Shanghai Jiaotong University School of Medicine

    Shanghai, 200001

  • Ruijin Hospital, Shanghai Jiaotong University, School of Medicine

    Shanghai, 200025

  • Shengjing Hospital Of China Medical University

    Shengyang, Liaoning

  • Peking University Shenzhen Hospital

    Shenzhen, Guangdong, 518036

  • The Second Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050005

  • The Third Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050051

  • The Second Hospital of Shanxi Medical University, Taiyuan

    Taiyuan, Shanxi, 030001

  • Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology

    Wuhan, Hubei, 430022

  • Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei, 430022

  • Renmin Hospital, Wuhan University

    Wuhan, Hubei, 430060

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450052

Other trials in China

Canada8 sites

  • University of Calgary/Alberta Health Services

    Calgary, Alberta, T2R 0X7

  • University of Alberta Hospitals

    Edmonton, Alberta, T6G 2B7

  • St. Joseph's Healthcare

    Hamiliton, Ontario, L8N 4A6

  • London Health Sciences Centre

    London, Ontario

  • Hôpital Maisonneuve-Rosemont

    Montreal, Quebec, H1T 2M4

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

  • Toronto General Hospital,

    Toronto, Ontario, M5G 2N2

  • St Pauls Hospital

    Vancouver, British Columbia, V6Z 1Y6

Other trials in Canada

Malaysia6 sites

  • Hospital Raja Permaisuri Bainun

    Ipoh, Perak, 30990

  • Hospital Sultanah Aminah

    Johor Bahru, Johor, 80100

  • University Malaysia Medical Centre

    Kuala Lumpur, Kuala Lumpur, 59100

  • Hospital Kuala Lumpur

    Kuala Lumpur, Kulala Lumpur, 50586

  • Hospital Umum Sarawak

    Kuching, Samarahan, 93586

  • Hospital Tuanku Jaafar Seremban

    Seremban, Negri Seremban, 70300

Other trials in Malaysia

India5 sites

  • Post Graduate Institue of Medical Education and Reasearch

    Chandigarh, Punjab, 160 012

  • Madras Medical College

    Chen, Tamil Nadu, 600037

  • Osmania General Hospital

    Hyderabad, Andhra Pradesh, 500012

  • Nizams Institute of Medical Sciences

    Hyderabad, Andhra Pradesh, 500082

  • Calicut Medical College

    Kozhikode, Kerala, 673008,

Other trials in India

Australia4 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • Concord Repatriation General Hospital

    Concord W., New South Wales, 2137

  • Nepean Hospital

    Kingswood, New South Wales, 2747

  • Royal North Shore Hospital

    St Leonards, New South Wales, 2065

Other trials in Australia

Hong Kong1 site

  • Princess Margaret Hospital

    Kowloon, Kowloon

Other trials in Hong Kong

About this study

Official title: 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).

Read the 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.

Keywords
kidney
Medical subject headings
Glomerulonephritis, IGA, Kidney Failure, Chronic, Glomerulonephritis, Kidney Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05434325
Study groupRoleWhat they receive
TESTING ParticpantsAll participants who were successfully randomised to the TESTING study who are still alive and have not reached kidney failure requiring dialysis.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Through study completion, an average of 1 year

Secondary outcomes (6)

  1. Secondary Aims

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

    Measured: Through study completion, an average of 1 year

  2. Secondary Aims

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

    Measured: Through Study completion, an average of 1 year

  3. Secondary Aims

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

    Measured: Through Study Completion, an average of 1 year

  4. Secondary Aims

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

    Measured: Through Study Completion, an average of 1 year

  5. Secondary Aims

    Annual eGFR decline rate

    Measured: Through Study Complication an average of 1 Year

  6. Secondary Aim

    Time averaged proteinuria post-randomization

    Measured: Through Study Completion an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jun 2022
  2. Study start7 Dec 2022
  3. Primary completion17 Jul 2025
  4. Study completion30 Aug 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
211 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05434325
Sponsor's protocol ID
TESTING-ON
Acronym
TESTING-ON
Status last verified
Jun 2025
First submitted
14 Jun 2022
Last updated
9 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of IgA Nephropathy and ESRD, run by The George Institute at 59 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 59 sites in China, Canada, Malaysia, India, Australia and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary AIM (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05434325.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.

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