Clinical trial NCT05434325: TESTING -ON Post-Trial ObservatioNal Cohort Study
Official title: Therapeutic Evaluation of STeroids in IgA Nephropathy Global - Post-Trial ObservatioNal Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: IgA Nephropathy
ESRD
Glomerulonephritis
Kidney Diseases
Keywords: kidney
Lead sponsor: The George Institute
Sponsor class: OTHER
Collaborators: name: Peking University Institute of Nephrology
First posted: 2022-06-28
Enrollment: 366
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Primary AIM
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Secondary Aims
timeFrame: Through study completion, an average of 1 year
measure: Secondary Aims
timeFrame: Through Study completion, an average of 1 year
measure: Secondary Aims
timeFrame: Through Study Completion, an average of 1 year
measure: Secondary Aims
timeFrame: Through Study Completion, an average of 1 year
measure: Secondary Aims
timeFrame: Through Study Complication an average of 1 Year
measure: Secondary Aim
timeFrame: Through Study Completion an average of 1 year
Other outcomes:
Locations:
city: Kingswood
country: Australia
facility: Nepean Hospital
state: New South Wales
city: St Leonards
country: Australia
facility: Royal North Shore Hospital
state: New South Wales
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Calgary
country: Canada
facility: University of Calgary/Alberta Health Services
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta Hospitals
state: Alberta
city: Vancouver
country: Canada
facility: St Pauls Hospital
state: British Columbia
city: Hamiliton
country: Canada
facility: St. Joseph's Healthcare
state: Ontario
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: Toronto General Hospital,
state: Ontario
city: Montreal
country: Canada
facility: Hôpital Maisonneuve-Rosemont
state: Quebec
city: Beijing
country: China
facility: Chinese PLA General Hospital (301 Hospital)
state: Beijing
city: Guangzhou
country: China
facility: The First Affiliated Hospital, Sun Yat-Sen University
state: Guangdong
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital, Guangzhou
state: Guangdong
city: Shenzhen
country: China
facility: Peking University Shenzhen Hospital
state: Guangdong
city: Shijiazhuang
country: China
facility: The Second Hospital of Hebei Medical University
state: Hebei
city: Shijiazhuang
country: China
facility: The Third Hospital of Hebei Medical University
state: Hebei
city: Luoyang
country: China
facility: The First Affiliated Hospital of Henan University of Science &Technology
state: Henan
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Wuhan
country: China
facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology
state: Hubei
city: Wuhan
country: China
facility: Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
city: Wuhan
country: China
facility: Renmin Hospital, Wuhan University
state: Hubei
city: Baotou
country: China
facility: The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology,
state: Inner Mongolia
city: Hohhot
country: China
facility: Inner Mongolia People's Hospital
state: Inner Mongolia
city: Nanjing
country: China
facility: The First Affiliated Hospital with Nanjing Medical University
state: Jiangsu
city: Changchun
country: China
facility: Jilin Province FAW General Hospital [Jilin University Fourth Hospital]
state: Jilin
city: Dalian
country: China
facility: he First Affiliated Hospital of Dalian Medical University, Dalian
state: Liaoning
city: Shengyang
country: China
facility: Shengjing Hospital Of China Medical University
state: Liaoning
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
city: Jinan
country: China
facility: The First Affiliated Hospital of Shangdong First Medical University,Shangdong Provincial Qianfoshin
state: Shandong
city: Jinan
country: China
facility: Shandong Provincial Hospital
state: Shandong
city: Jinan
country: China
facility: Jinan Military General Hospital
state: Shandong
city: Taiyuan
country: China
facility: The Second Hospital of Shanxi Medical University, Taiyuan
state: Shanxi
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
city: Chengdu
country: China
facility: Sichuan Academy of Medical Science, Sichuan Provincial People's Hospital
state: Sichuan
city: Hangzhou
country: China
facility: The First Affiliated Hospital, Zhejiang University of Medicine
state: Zhejiang
city: Hangzhou
country: China
facility: Hangzhou Hospital of Traditional Chinese Medicine,
state: Zhejiang
city: Ningbo
country: China
facility: Ningbo Urology & Nephrology Hospital
state: Zhejiang
city: Sangzhou
country: China
facility: Zhejiang Provincial People's Hospital
state: Zhejiang
city: Beijing
country: China
facility: Beijing Anzhen Hospital, Capital Medical University
city: Beijing
country: China
facility: Peking University First Hospital
city: Beijing
country: China
facility: Peking University People's Hospital
city: Beijing
country: China
facility: Peking University Third Hospital
city: Chongqing
country: China
facility: XinQiao Hospital, Third Military Medical University
city: Shanghai
country: China
facility: Renji Hospital, Shanghai Jiaotong University School of Medicine
city: Shanghai
country: China
facility: Ruijin Hospital, Shanghai Jiaotong University, School of Medicine
city: Kowloon
country: Hong Kong
facility: Princess Margaret Hospital
city: Hyderabad
country: India
facility: Osmania General Hospital
state: Andhra Pradesh
city: Hyderabad
country: India
facility: Nizams Institute of Medical Sciences
state: Andhra Pradesh
city: Kozhikode
country: India
facility: Calicut Medical College
state: Kerala
city: Chandigarh
country: India
facility: Post Graduate Institue of Medical Education and Reasearch
state: Punjab
city: Chen
country: India
facility: Madras Medical College
state: Tamil Nadu
city: Johor Bahru
country: Malaysia
facility: Hospital Sultanah Aminah
state: Johor
city: Kuala Lumpur
country: Malaysia
facility: Hospital Kuala Lumpur
state: Kulala Lumpur
city: Seremban
country: Malaysia
facility: Hospital Tuanku Jaafar Seremban
state: Negri Seremban
city: Ipoh
country: Malaysia
facility: Hospital Raja Permaisuri Bainun
state: Perak
city: Kuching
country: Malaysia
facility: Hospital Umum Sarawak
state: Samarahan
city: Kuala Lumpur
country: Malaysia
facility: University Malaysia Medical Centre
Study officials:
affiliation: Peking University Institute of Nephrology
name: Hong Zhang, Prof
role: STUDY_CHAIR
affiliation: University of New South Wales
name: Vlado Perkovic, Prof
role: STUDY_CHAIR
affiliation: University of New Souht Wales
name: Muh Geot Wong, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Peking University of Nephrology
name: Jicheng Lv
role: PRINCIPAL_INVESTIGATOR
References: