503
Participants
Start Date
May 5, 2012
Primary Completion Date
July 23, 2021
Study Completion Date
July 23, 2021
methylprednisolone
"Original Cohort:~Oral methylprednisolone or placebo 0.8mg/kg/day with a maximum of 48mg/day x 2months, taper by 8mg/day every month, patients will also receive optimal blood pressure control and full dose of ACE inhibitors or ARBs as recommended by guidelines~Low Dose Cohort:~Oral methylprednisolone or placebo 0.4mg/kg/day with a maximum 32mg/day and minimum of 24mg/day then reducing over 6-9months. All the patients will also receive optimal blood pressure control and full dose of ACE inhibitors or ARBs as recommended by guidelines throughout the trial.~Prophylactic trimethoprim/sulfamethoxazole (a single strength tablet daily or half a double strength tablet daily) will be used during the first 3 months after randomisation in the low dose cohort, for the prevention of severe PJP infection, unless there is a documented sulfa allergy."
Placebo
"Intervention: Drug: Placebo~Original Cohort:~Matching placebo tablets, all the patients will receive optimal blood pressure control and full dose of ACE inhibitors or ARBs as recommended by guidelines throughout the trial.~Low Dose cohort:~Matching placebo will be given reducing over 6-9months. All the patients will also receive optimal blood pressure control and full dose of ACE inhibitors or ARBs as recommended by guidelines throughout the trial.~Prophylactic trimethoprim/sulfamethoxazole (a single strength tablet daily or half a double strength tablet daily) will be used during the first 3 months after randomisation in the low dose cohort, for the prevention of severe PJP infection, unless there is a documented sulfa allergy"
Royal North Shore Hospital, St Leonards
Concord Repatriation and General Hospital, Concord
Nepean Hospital, Kingswood
Royal Melbourne Hospital, Melbourne
Royal Adelaide Hospital, Adelaide
Hospital Raja Permaisuri Bainun, Ipoh
Hospital Kuala Lumpur, Kuala Lumpur
University Malaysia Medical Centre, Kuala Lumpur
Hospital Tuanku Jaafar Seremban, Seremban
Hospital Sultanah Aminah, Johor Bahru
Hospital Umum Sarawak, Kuching
Beijing Anzhen Hospital, Capital Medical University, Beijing
Peking University First Hospital, Beijing
Peking University People's Hospital, Beijing
Beijing Hospital, Beijing
he First Affiliated Hospital of Dalian Medical University, Dalian, Dalian
Jilin Province FAW General Hospital [Jilin University Fourth Hospital], Changchun
Renji Hospital, Shanghai Jiaotong University School of Medicine, Shanghai
Ruijin Hospital, Shanghai Jiaotong University, School of Medicine, Shanghai
Huashan Hospital, Medical Centre of Fudan University, Shanghai
General Hospital of Eastern Theater Command, Nanjing
The First Affiliated Hospital with Nanjing Medical University, Nanjing
Sanjay Gandhi Post Graduate Institute of Medical Science, Lucknow
Qilu Hospital of Shandong University, Jinan
The First Affiliated Hospital of Shangdong First Medical University,Shangdong Provincial Qianfoshin, Jinan
Shandong Provincial Hospital, Jinan
Yantai Yuhuangding Hospital, Yantai
The First Affiliated Hospital, Zhejiang University of Medicine, Hangzhou
XinQiao Hospital, Third Military Medical University, Chongqing
ongji Hospital, Tongji Medical College, Huazhong University of Science & Technology, Wuhan
Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology, Wuhan
Renmin Hospital, Wuhan University, Wuhan
Henan Provincial People's Hospital, Zhengzhou
The First Affiliated Hospital of Zhengzhou University, Zhengzhou
The First Affiliated Hospital of Henan University of Science &Technology, Luoyang
Osmania General Hospital, Hyderabad
The First Affiliated Hospital, Sun Yat-Sen University, Guangzhou
Peking University Shenzhen Hospital, Shenzhen
Madras Medical College, Chen
West China Hospital of Sichuan University, Chengdu
Sichuan Academy of Medical Science, Sichuan Provincial People's Hospital, Chengdu
University of Calgary/Alberta Health Services, Calgary
University of Alberta Hospitals, Edmonton
St Pauls Hospital, Vancouver
St. Joseph's Healthcare, Hamiliton
London Health Sciences Centre, London
Sunnybrook Health Sciences Centre, Toronto
Toronto General Hospital,, Toronto
Hôpital Maisonneuve-Rosemont, Montreal
Chinese PLA General Hospital (301 Hospital), Beijing
Guangdong Provincial People's Hospital, Guangzhou, Guangzhou
Shengjing Hospital Of China Medical University, Shengyang
Jinan Military General Hospital, Jinan
Hangzhou Hospital of Traditional Chinese Medicine,, Hangzhou
Ningbo Urology & Nephrology Hospital, Ningbo
Zhejiang Provincial People's Hospital, Sangzhou
Peking University Third Hospital, Beijing
Princess Margaret Hospital, Kowloon
The Second Hospital of Hebei Medical University, Shijiazhuang
The Third Hospital of Hebei Medical University, Shijiazhuang
The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology,, Baotou
Inner Mongolia People's Hospital, Hohhot
he Second Hospital of Shanxi Medical University, Taiyuan, Taiyuan
Nizam's Institute of Medical Science, Hyderabad
Calicut Medical College, Kozhikode
Post Graduate Institue of Medical Education and Reasearch, Chandigarh
Peking University First Hospital
OTHER
The George Institute
OTHER