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TESTING-ON: TESTING -ON Post-Trial ObservatioNal Cohort Study

Sponsor
The George Institute (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05434325
Collaborator
Peking University Institute of Nephrology (Other)
366
Enrollment
60
Locations
60
Anticipated Duration (Months)
6.1
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    366 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Therapeutic Evaluation of STeroids in IgA Nephropathy Global - Post-Trial ObservatioNal Cohort Study
    Anticipated Study Start Date :
    Jul 30, 2022
    Anticipated Primary Completion Date :
    Jul 30, 2027
    Anticipated Study Completion Date :
    Jul 30, 2027

    Arms and Interventions

    Arm Intervention/Treatment
    TESTING Particpants

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

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Secondary Aims [Through study completion, an average of 1 year]

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

    2. Secondary Aims [Through Study completion, an average of 1 year]

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

    3. Secondary Aims [Through Study Completion, an average of 1 year]

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

    4. Secondary Aims [Through Study Completion, an average of 1 year]

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

    5. Secondary Aims [Through Study Complication an average of 1 Year]

      Annual eGFR decline rate

    6. Secondary Aim [Through Study Completion an average of 1 year]

      Time averaged proteinuria post-randomization

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 100 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Nepean Hospital Kingswood New South Wales Australia 2747
    2 Royal North Shore Hospital St Leonards New South Wales Australia 2065
    3 Royal Adelaide Hospital Adelaide South Australia Australia 5000
    4 Royal Melbourne Hospital Melbourne Victoria Australia 3052
    5 University of Calgary/Alberta Health Services Calgary Alberta Canada T2R 0X7
    6 University of Alberta Hospitals Edmonton Alberta Canada T6G 2B7
    7 St Pauls Hospital Vancouver British Columbia Canada V6Z 1Y6
    8 St. Joseph's Healthcare Hamiliton Ontario Canada L8N 4A6
    9 Sunnybrook Health Sciences Centre Toronto Ontario Canada M4N 3M5
    10 Toronto General Hospital, Toronto Ontario Canada M5G 2N2
    11 Hôpital Maisonneuve-Rosemont Montreal Quebec Canada H1T 2M4
    12 Chinese PLA General Hospital (301 Hospital) Beijing Beijing China
    13 The First Affiliated Hospital, Sun Yat-Sen University Guangzhou Guangdong China 510080
    14 Guangdong Provincial People's Hospital, Guangzhou Guangzhou Guangdong China
    15 Peking University Shenzhen Hospital Shenzhen Guangdong China 518036
    16 The Second Hospital of Hebei Medical University Shijiazhuang Hebei China 050005
    17 The Third Hospital of Hebei Medical University Shijiazhuang Hebei China 050051
    18 The First Affiliated Hospital of Henan University of Science &Technology Luoyang Henan China 471003
    19 Henan Provincial People's Hospital Zhengzhou Henan China 450003
    20 The First Affiliated Hospital of Zhengzhou University Zhengzhou Henan China 450052
    21 ongji Hospital, Tongji Medical College, Huazhong University of Science & Technology Wuhan Hubei China 430022
    22 Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology Wuhan Hubei China 430022
    23 Renmin Hospital, Wuhan University Wuhan Hubei China 430060
    24 The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology, Baotou Inner Mongolia China 014010
    25 Inner Mongolia People's Hospital Hohhot Inner Mongolia China 010017
    26 The First Affiliated Hospital with Nanjing Medical University Nanjing Jiangsu China 210029
    27 Jilin Province FAW General Hospital [Jilin University Fourth Hospital] Changchun Jilin China 130011
    28 he First Affiliated Hospital of Dalian Medical University, Dalian Dalian Liaoning China 116011
    29 Shengjing Hospital Of China Medical University Shengyang Liaoning China
    30 Qilu Hospital of Shandong University Jinan Shandong China 250012
    31 The First Affiliated Hospital of Shangdong First Medical University,Shangdong Provincial Qianfoshin Jinan Shandong China 250014
    32 Shandong Provincial Hospital Jinan Shandong China 250021
    33 Jinan Military General Hospital Jinan Shandong China
    34 he Second Hospital of Shanxi Medical University, Taiyuan Taiyuan Shanxi China 030001
    35 West China Hospital of Sichuan University Chengdu Sichuan China 610041
    36 Sichuan Academy of Medical Science, Sichuan Provincial People's Hospital Chengdu Sichuan China 610072
    37 The First Affiliated Hospital, Zhejiang University of Medicine Hangzhou Zhejiang China 310003
    38 Hangzhou Hospital of Traditional Chinese Medicine, Hangzhou Zhejiang China
    39 Ningbo Urology & Nephrology Hospital Ningbo Zhejiang China
    40 Zhejiang Provincial People's Hospital Sangzhou Zhejiang China
    41 Beijing Anzhen Hospital, Capital Medical University Beijing China 100029
    42 Peking University First Hospital Beijing China 100034
    43 Peking University People's Hospital Beijing China 100035
    44 Beijing Hospital Beijing China 100730
    45 Peking University Third Hospital Beijing China
    46 XinQiao Hospital, Third Military Medical University Chongqing China 400037
    47 Renji Hospital, Shanghai Jiaotong University School of Medicine Shanghai China 200001
    48 Ruijin Hospital, Shanghai Jiaotong University, School of Medicine Shanghai China 200025
    49 Princess Margaret Hospital Kowloon Hong Kong
    50 Osmania General Hospital Hyderabad Andhra Pradesh India 500012
    51 Calicut Medical College Kozhikode Kerala India 673008,
    52 Post Graduate Institue of Medical Education and Reasearch Chandigarh Punjab India 160 012
    53 Madras Medical College Chen Tamil Nadu India 600037
    54 Sanjay Gandhi Post Graduate Institute of Medical Science Lucknow Uttar Pradesh India 226014
    55 Hospital Sultanah Aminah Johor Bahru Johor Malaysia 80100
    56 Hospital Kuala Lumpur Kuala Lumpur Kulala Lumpur Malaysia 50586
    57 Hospital Tuanku Jaafar Seremban Seremban Negri Seremban Malaysia 70300
    58 Hospital Raja Permaisuri Bainun Ipoh Perak Malaysia 30990
    59 Hospital Umum Sarawak Kuching Samarahan Malaysia 93586
    60 University Malaysia Medical Centre Kuala Lumpur Malaysia 59100

    Sponsors and Collaborators

    • The George Institute
    • Peking University Institute of Nephrology

    Investigators

    • Study Chair: Hong Zhang, Prof, Peking University Institute of Nephrology
    • Study Chair: Vlado Perkovic, Prof, University of New South Wales
    • Principal Investigator: Muh Geot Wong, Dr, University of New Souht Wales
    • Principal Investigator: Jicheng Lv, Peking University of Nephrology

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    The George Institute
    ClinicalTrials.gov Identifier:
    NCT05434325
    Other Study ID Numbers:
    • TESTING-ON
    First Posted:
    Jun 28, 2022
    Last Update Posted:
    Jun 28, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by The George Institute
    kidney
    Additional relevant MeSH terms:
    Kidney Diseases
    Glomerulonephritis, IGA
    Glomerulonephritis

    Study Results

    No Results Posted as of Jun 28, 2022