TESTING -ON Post-Trial ObservatioNal Cohort Study
- Conditions
- ESRDGlomerulonephritisKidney DiseasesIgA Nephropathy
- Registration Number
- NCT05434325
- Lead Sponsor
- The George Institute
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 366
- Only participants who were randomised into the TESTING trial
Exclusion Criteria
- 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
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary AIM Through study completion, an average of 1 year The development of end stage kidney disease (ESKD) defined as a need for maintenance dialysis or kidney transplantation, and death due to kidney disease
- Secondary Outcome Measures
Name Time Method Secondary Aim Through Study Completion an average of 1 year Time averaged proteinuria post-randomization
Secondary Aims Through Study Complication an average of 1 Year Annual eGFR decline rate
Trial Locations
- Locations (58)
Royal Adelaide Hospital
🇦🇺Adelaide, South Australia, Australia
University of Calgary/Alberta Health Services
🇨🇦Calgary, Alberta, Canada
University of Alberta Hospitals
🇨🇦Edmonton, Alberta, Canada
Hôpital Maisonneuve-Rosemont
🇨🇦Montreal, Quebec, Canada
The Second Hospital of Shanxi Medical University, Taiyuan
🇨🇳Taiyuan, Shanxi, China
St. Joseph's Healthcare
🇨🇦Hamiliton, Ontario, Canada
Toronto General Hospital,
🇨🇦Toronto, Ontario, Canada
The Second Hospital of Hebei Medical University
🇨🇳Shijiazhuang, Hebei, China
Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology
🇨🇳Wuhan, Hubei, China
Royal North Shore Hospital
🇦🇺St Leonards, New South Wales, Australia
St Pauls Hospital
🇨🇦Vancouver, British Columbia, Canada
Peking University Shenzhen Hospital
🇨🇳Shenzhen, Guangdong, China
London Health Sciences Centre
🇨🇦London, Ontario, Canada
Nepean Hospital
🇦🇺Kingswood, New South Wales, Australia
Sunnybrook Health Sciences Centre
🇨🇦Toronto, Ontario, Canada
The First Affiliated Hospital of Zhengzhou University
🇨🇳Zhengzhou, Henan, China
Renmin Hospital, Wuhan University
🇨🇳Wuhan, Hubei, China
Ningbo Urology & Nephrology Hospital
🇨🇳Ningbo, Zhejiang, China
Beijing Anzhen Hospital, Capital Medical University
🇨🇳Beijing, China
The First Affiliated Hospital, Sun Yat-Sen University
🇨🇳Guangzhou, Guangdong, China
Guangdong Provincial People's Hospital, Guangzhou
🇨🇳Guangzhou, Guangdong, China
Jilin Province FAW General Hospital [Jilin University Fourth Hospital]
🇨🇳Changchun, Jilin, China
West China Hospital of Sichuan University
🇨🇳Chengdu, Sichuan, China
The First Affiliated Hospital, Zhejiang University of Medicine
🇨🇳Hangzhou, Zhejiang, China
Hangzhou Hospital of Traditional Chinese Medicine,
🇨🇳Hangzhou, Zhejiang, China
Peking University First Hospital
🇨🇳Beijing, China
Ruijin Hospital, Shanghai Jiaotong University, School of Medicine
🇨🇳Shanghai, China
Princess Margaret Hospital
🇭🇰Kowloon, Hong Kong
Madras Medical College
🇮🇳Chen, Tamil Nadu, India
Chinese PLA General Hospital (301 Hospital)
🇨🇳Beijing, Beijing, China
The Third Hospital of Hebei Medical University
🇨🇳Shijiazhuang, Hebei, China
The First Affiliated Hospital of Henan University of Science &Technology
🇨🇳Luoyang, Henan, China
he First Affiliated Hospital of Dalian Medical University, Dalian
🇨🇳Dalian, Liaoning, China
Shengjing Hospital Of China Medical University
🇨🇳Shengyang, Liaoning, China
Qilu Hospital of Shandong University
🇨🇳Jinan, Shandong, China
Shandong Provincial Hospital
🇨🇳Jinan, Shandong, China
Zhejiang Provincial People's Hospital
🇨🇳Sangzhou, Zhejiang, China
Peking University People's Hospital
🇨🇳Beijing, China
Renji Hospital, Shanghai Jiaotong University School of Medicine
🇨🇳Shanghai, China
The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology,
🇨🇳Baotou, Inner Mongolia, China
XinQiao Hospital, Third Military Medical University
🇨🇳Chongqing, China
Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
🇨🇳Wuhan, Hubei, China
Inner Mongolia People's Hospital
🇨🇳Hohhot, Inner Mongolia, China
The First Affiliated Hospital with Nanjing Medical University
🇨🇳Nanjing, Jiangsu, China
Sichuan Academy of Medical Science, Sichuan Provincial People's Hospital
🇨🇳Chengdu, Sichuan, China
Hospital Umum Sarawak
🇲🇾Kuching, Samarahan, Malaysia
The First Affiliated Hospital of Shangdong First Medical University,Shangdong Provincial Qianfoshin
🇨🇳Jinan, Shandong, China
Jinan Military General Hospital
🇨🇳Jinan, Shandong, China
Peking University Third Hospital
🇨🇳Beijing, China
Post Graduate Institue of Medical Education and Reasearch
🇮🇳Chandigarh, Punjab, India
Hospital Sultanah Aminah
🇲🇾Johor Bahru, Johor, Malaysia
Hospital Raja Permaisuri Bainun
🇲🇾Ipoh, Perak, Malaysia
Osmania General Hospital
🇮🇳Hyderabad, Andhra Pradesh, India
Nizams Institute of Medical Sciences
🇮🇳Hyderabad, Andhra Pradesh, India
Hospital Tuanku Jaafar Seremban
🇲🇾Seremban, Negri Seremban, Malaysia
University Malaysia Medical Centre
🇲🇾Kuala Lumpur, Malaysia
Calicut Medical College
🇮🇳Kozhikode, Kerala, India
Hospital Kuala Lumpur
🇲🇾Kuala Lumpur, Kulala Lumpur, Malaysia