TESTING -ON Post-Trial ObservatioNal Cohort Study

NCT ID: NCT05434325

Last Updated: 2025-02-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

366 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-12-07

Study Completion Date

2027-07-30

Brief Summary

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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

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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.

Conditions

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IgA Nephropathy ESRD Glomerulonephritis Kidney Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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TESTING Particpants

All participants who were successfully randomised to the TESTING study who are still alive and have not reached kidney failure requiring dialysis.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University Institute of Nephrology

UNKNOWN

Sponsor Role collaborator

The George Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hong Zhang, Prof

Role: STUDY_CHAIR

Peking University Institute of Nephrology

Vlado Perkovic, Prof

Role: STUDY_CHAIR

University of New South Wales

Muh Geot Wong, Dr

Role: PRINCIPAL_INVESTIGATOR

University of New Souht Wales

Jicheng Lv

Role: PRINCIPAL_INVESTIGATOR

Peking University of Nephrology

Locations

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Nepean Hospital

Kingswood, New South Wales, Australia

Site Status RECRUITING

Royal North Shore Hospital

St Leonards, New South Wales, Australia

Site Status RECRUITING

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Site Status RECRUITING

University of Calgary/Alberta Health Services

Calgary, Alberta, Canada

Site Status NOT_YET_RECRUITING

University of Alberta Hospitals

Edmonton, Alberta, Canada

Site Status RECRUITING

St Pauls Hospital

Vancouver, British Columbia, Canada

Site Status NOT_YET_RECRUITING

St. Joseph's Healthcare

Hamiliton, Ontario, Canada

Site Status NOT_YET_RECRUITING

London Health Sciences Centre

London, Ontario, Canada

Site Status COMPLETED

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Site Status RECRUITING

Toronto General Hospital,

Toronto, Ontario, Canada

Site Status NOT_YET_RECRUITING

Hôpital Maisonneuve-Rosemont

Montreal, Quebec, Canada

Site Status NOT_YET_RECRUITING

Chinese PLA General Hospital (301 Hospital)

Beijing, Beijing Municipality, China

Site Status RECRUITING

The First Affiliated Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, China

Site Status NOT_YET_RECRUITING

Guangdong Provincial People's Hospital, Guangzhou

Guangzhou, Guangdong, China

Site Status ACTIVE_NOT_RECRUITING

Peking University Shenzhen Hospital

Shenzhen, Guangdong, China

Site Status RECRUITING

The Second Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Site Status RECRUITING

The Third Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Site Status RECRUITING

The First Affiliated Hospital of Henan University of Science &Technology

Luoyang, Henan, China

Site Status RECRUITING

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Site Status NOT_YET_RECRUITING

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

Wuhan, Hubei, China

Site Status NOT_YET_RECRUITING

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

Wuhan, Hubei, China

Site Status RECRUITING

Renmin Hospital, Wuhan University

Wuhan, Hubei, China

Site Status NOT_YET_RECRUITING

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

Baotou, Inner Mongolia, China

Site Status NOT_YET_RECRUITING

Inner Mongolia People's Hospital

Hohhot, Inner Mongolia, China

Site Status RECRUITING

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, China

Site Status NOT_YET_RECRUITING

Jilin Province FAW General Hospital [Jilin University Fourth Hospital]

Changchun, Jilin, China

Site Status NOT_YET_RECRUITING

he First Affiliated Hospital of Dalian Medical University, Dalian

Dalian, Liaoning, China

Site Status NOT_YET_RECRUITING

Shengjing Hospital Of China Medical University

Shengyang, Liaoning, China

Site Status RECRUITING

Qilu Hospital of Shandong University

Jinan, Shandong, China

Site Status NOT_YET_RECRUITING

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

Jinan, Shandong, China

Site Status RECRUITING

Shandong Provincial Hospital

Jinan, Shandong, China

Site Status NOT_YET_RECRUITING

Jinan Military General Hospital

Jinan, Shandong, China

Site Status NOT_YET_RECRUITING

The Second Hospital of Shanxi Medical University, Taiyuan

Taiyuan, Shanxi, China

Site Status NOT_YET_RECRUITING

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Site Status RECRUITING

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

Chengdu, Sichuan, China

Site Status NOT_YET_RECRUITING

The First Affiliated Hospital, Zhejiang University of Medicine

Hangzhou, Zhejiang, China

Site Status NOT_YET_RECRUITING

Hangzhou Hospital of Traditional Chinese Medicine,

Hangzhou, Zhejiang, China

Site Status RECRUITING

Ningbo Urology & Nephrology Hospital

Ningbo, Zhejiang, China

Site Status NOT_YET_RECRUITING

Zhejiang Provincial People's Hospital

Sangzhou, Zhejiang, China

Site Status RECRUITING

Beijing Anzhen Hospital, Capital Medical University

Beijing, , China

Site Status NOT_YET_RECRUITING

Peking University First Hospital

Beijing, , China

Site Status RECRUITING

Peking University People's Hospital

Beijing, , China

Site Status NOT_YET_RECRUITING

Peking University Third Hospital

Beijing, , China

Site Status NOT_YET_RECRUITING

XinQiao Hospital, Third Military Medical University

Chongqing, , China

Site Status RECRUITING

Renji Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, , China

Site Status NOT_YET_RECRUITING

Ruijin Hospital, Shanghai Jiaotong University, School of Medicine

Shanghai, , China

Site Status NOT_YET_RECRUITING

Princess Margaret Hospital

Kowloon, , Hong Kong

Site Status COMPLETED

Osmania General Hospital

Hyderabad, Andhra Pradesh, India

Site Status RECRUITING

Nizams Institute of Medical Sciences

Hyderabad, Andhra Pradesh, India

Site Status NOT_YET_RECRUITING

Calicut Medical College

Kozhikode, Kerala, India

Site Status RECRUITING

Post Graduate Institue of Medical Education and Reasearch

Chandigarh, Punjab, India

Site Status RECRUITING

Madras Medical College

Chen, Tamil Nadu, India

Site Status RECRUITING

Hospital Sultanah Aminah

Johor Bahru, Johor, Malaysia

Site Status RECRUITING

Hospital Kuala Lumpur

Kuala Lumpur, Kulala Lumpur, Malaysia

Site Status RECRUITING

Hospital Tuanku Jaafar Seremban

Seremban, Negri Seremban, Malaysia

Site Status RECRUITING

Hospital Raja Permaisuri Bainun

Ipoh, Perak, Malaysia

Site Status RECRUITING

Hospital Umum Sarawak

Kuching, Samarahan, Malaysia

Site Status RECRUITING

University Malaysia Medical Centre

Kuala Lumpur, , Malaysia

Site Status RECRUITING

Countries

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Australia Canada China Hong Kong India Malaysia

Central Contacts

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Rebecca Anderson

Role: CONTACT

+61401401440

Helen Monaghan

Role: CONTACT

+61 0280524425

Other Identifiers

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TESTING-ON

Identifier Type: -

Identifier Source: org_study_id

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