TESTING -ON Post-Trial ObservatioNal Cohort Study

Kidney Diseases Clinical Trial

— TESTING-ON  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05434325
• Other study ID #: TESTING-ON
• Status: Recruiting
• Start date: December 7, 2022
• Est. completion date: July 30, 2027

Study information

• Verified date: January 2023
• Source: The George Institute
• Contact: Rebecca Anderson
• Phone: +61401401440
• Email: randerson[@]georgeinstitute.org.au
• Is FDA regulated: No
• Study type: Observational

Clinical 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 below 60 mL/min/1.73m2).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 366
• Est. completion date: July 30, 2027
• Est. primary completion date: July 30, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• ESRD
• Glomerulonephritis
• Glomerulonephritis, IGA
• IgA Nephropathy
• Kidney Diseases

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital	Adelaide	South Australia
Australia	Nepean Hospital	Kingswood	New South Wales
Australia	Royal North Shore Hospital	St Leonards	New South Wales
Canada	University of Calgary/Alberta Health Services	Calgary	Alberta
Canada	University of Alberta Hospitals	Edmonton	Alberta
Canada	St. Joseph's Healthcare	Hamiliton	Ontario
Canada	Hôpital Maisonneuve-Rosemont	Montreal	Quebec
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario
Canada	Toronto General Hospital,	Toronto	Ontario
Canada	St Pauls Hospital	Vancouver	British Columbia
China	The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology,	Baotou	Inner Mongolia
China	Beijing Anzhen Hospital, Capital Medical University	Beijing
China	Beijing Hospital	Beijing
China	Chinese PLA General Hospital (301 Hospital)	Beijing	Beijing
China	Peking University First Hospital	Beijing
China	Peking University People's Hospital	Beijing
China	Peking University Third Hospital	Beijing
China	Jilin Province FAW General Hospital [Jilin University Fourth Hospital]	Changchun	Jilin
China	Sichuan Academy of Medical Science, Sichuan Provincial People's Hospital	Chengdu	Sichuan
China	West China Hospital of Sichuan University	Chengdu	Sichuan
China	XinQiao Hospital, Third Military Medical University	Chongqing
China	he First Affiliated Hospital of Dalian Medical University, Dalian	Dalian	Liaoning
China	Guangdong Provincial People's Hospital, Guangzhou	Guangzhou	Guangdong
China	The First Affiliated Hospital, Sun Yat-Sen University	Guangzhou	Guangdong
China	Hangzhou Hospital of Traditional Chinese Medicine,	Hangzhou	Zhejiang
China	The First Affiliated Hospital, Zhejiang University of Medicine	Hangzhou	Zhejiang
China	Inner Mongolia People's Hospital	Hohhot	Inner Mongolia
China	Jinan Military General Hospital	Jinan	Shandong
China	Qilu Hospital of Shandong University	Jinan	Shandong
China	Shandong Provincial Hospital	Jinan	Shandong
China	The First Affiliated Hospital of Shangdong First Medical University,Shangdong Provincial Qianfoshin	Jinan	Shandong
China	The First Affiliated Hospital of Henan University of Science &Technology	Luoyang	Henan
China	The First Affiliated Hospital with Nanjing Medical University	Nanjing	Jiangsu
China	Ningbo Urology & Nephrology Hospital	Ningbo	Zhejiang
China	Zhejiang Provincial People's Hospital	Sangzhou	Zhejiang
China	Renji Hospital, Shanghai Jiaotong University School of Medicine	Shanghai
China	Ruijin Hospital, Shanghai Jiaotong University, School of Medicine	Shanghai
China	Shengjing Hospital Of China Medical University	Shengyang	Liaoning
China	Peking University Shenzhen Hospital	Shenzhen	Guangdong
China	The Second Hospital of Hebei Medical University	Shijiazhuang	Hebei
China	The Third Hospital of Hebei Medical University	Shijiazhuang	Hebei
China	he Second Hospital of Shanxi Medical University, Taiyuan	Taiyuan	Shanxi
China	ongji Hospital, Tongji Medical College, Huazhong University of Science & Technology	Wuhan	Hubei
China	Renmin Hospital, Wuhan University	Wuhan	Hubei
China	Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei
China	Henan Provincial People's Hospital	Zhengzhou	Henan
China	The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan
Hong Kong	Princess Margaret Hospital	Kowloon
India	Post Graduate Institue of Medical Education and Reasearch	Chandigarh	Punjab
India	Madras Medical College	Chen	Tamil Nadu
India	Nizams Institute of Medical Sciences	Hyderabad	Andhra Pradesh
India	Osmania General Hospital	Hyderabad	Andhra Pradesh
India	Calicut Medical College	Kozhikode	Kerala
Malaysia	Hospital Raja Permaisuri Bainun	Ipoh	Perak
Malaysia	Hospital Sultanah Aminah	Johor Bahru	Johor
Malaysia	Hospital Kuala Lumpur	Kuala Lumpur	Kulala Lumpur
Malaysia	University Malaysia Medical Centre	Kuala Lumpur
Malaysia	Hospital Umum Sarawak	Kuching	Samarahan
Malaysia	Hospital Tuanku Jaafar Seremban	Seremban	Negri Seremban

Sponsors (2)

Lead Sponsor	Collaborator
The George Institute	Peking University Institute of Nephrology

Countries where clinical trial is conducted

Australia,  Canada,  China,  Hong Kong,  India,  Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Secondary Aims	The composite of ESKD, 30% decrease in eGFR and all cause death	Through study completion, an average of 1 year
Secondary	Secondary Aims	The composite of ESKD, 40% decrease in eGFR and all cause death	Through Study completion, an average of 1 year
Secondary	Secondary Aims	The composite of ESKD, 50% decrease in eGFR and all cause death	Through Study Completion, an average of 1 year
Secondary	Secondary Aims	Each of ESKD, death due to kidney disease and all cause death	Through Study Completion, an average of 1 year
Secondary	Secondary Aims	Annual eGFR decline rate	Through Study Complication an average of 1 Year
Secondary	Secondary Aim	Time averaged proteinuria post-randomization	Through Study Completion an average of 1 year