Therapeutic Evaluation of Steroids in IgA Nephropathy Global Study (TESTING Study)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by The George Institute
Sponsor:
Collaborator:
Peking University First Hospital
Information provided by (Responsible Party):
The George Institute
ClinicalTrials.gov Identifier:
NCT01560052
First received: March 15, 2012
Last updated: March 4, 2015
Last verified: February 2014
  Purpose

This study will evaluate the long-term efficacy and safety of oral methylprednisolone on a background of routine RAS inhibitor therapy, in preventing kidney events in patients with IgA nephropathy and features suggesting a high risk of progression


Condition Intervention
IgA Glomerulonephritis
Drug: methylprednisolone
Drug: Placebo,

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Therapeutic Evaluation of Steroids in IgA Nephropathy Global Study

Resource links provided by NLM:


Further study details as provided by The George Institute:

Primary Outcome Measures:
  • Progressive kidney failure [ Time Frame: 1-6 years ] [ Designated as safety issue: No ]
    Progressive kidney failure, which is a composite of a 50% decrease in eGFR, the development of end stage kidney disease defined as a need for maintenance dialysis or kidney transplantation, and death due to kidney disease.


Secondary Outcome Measures:
  • The composite of ESKD, 50% decrease in eGFR and all cause death [ Time Frame: 1-6 years ] [ Designated as safety issue: No ]
  • Each of ESKD, renal death and all cause death [ Time Frame: 1-6 years ] [ Designated as safety issue: No ]
  • Proteinuria remission [ Time Frame: 1-6 years ] [ Designated as safety issue: No ]
  • Annual eGFR decline rate [ Time Frame: 1-6 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 1300
Study Start Date: April 2012
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: oral methylprednisolone
methylprednisolone group; start at 0.8mg/kg/day with a maximal 48mg/day×2 months, taper by 8mg/day every month to stop within 6-8 months; Optimal blood pressure control and full dose of ACE inhibitors or ARBs as recommended by guidelines.
Drug: methylprednisolone
oral methylprednisolone or placebo 0.8mg/kg/day with a maximum 48mg/day x 2 months, taper by 8mg/day every month to stop within 6-8 months. 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.
Other Name: Medrol
Placebo Comparator: placebo
Matching placebo ; Optimal blood pressure control and full dose of ACE inhibitors or ARBs as recommended by guidelines.
Drug: Placebo,
Matching placebo tablets; 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.

Detailed Description:

Study outcomes

  • Primary outcome Progressive kidney failure, which is a composite of a 50% decrease in eGFR, the development of end stage kidney disease defined as a need for maintenance dialysis or kidney transplantation, and death due to kidney disease
  • Secondary outcomes The composite of ESKD, 50% decrease in eGFR and all cause death; Each of ESKD, renal death and all cause death; Annual eGFR decline rate; Proteinuria remission
  Eligibility

Ages Eligible for Study:   14 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. IgA nephropathy proven on renal biopsy within the previous 2 years yet can extend to 3 years
  2. Proteinuria: >1.0g/day while receiving maximum tolerated dose of RAS blockade following the recommended treatment guidelines of each country where the trial is conducted.
  3. eGFR: 20 to 70ml/min per 1.73m²

Exclusion Criteria:

  1. Indication for immunosuppressive therapy with corticosteroids, such as:

    • Minimal change renal disease with IgA deposits
    • Crescents present in >50% of glomeruli on a renal biopsy within the last 12 months.
  2. Contraindication to immunosuppressive therapy with corticosteroids, including

    • Active infection, including HBV infection or clinical evidence of latent or active tuberculosis (nodules, cavities, tuberculoma, etc)
    • Malignancy within the last 5 years, excluding treated non-melanoma skin cancers (ie. squamous or basal cell carcinoma)
    • Current or planned pregnancy or breastfeeding
    • Women of childbearing age who are not able or willing to use adequate contraception
  3. Systemic immunosuppressive therapy in the previous year.
  4. Malignant /uncontrolled hypertension (>160mm systolic or 110mmHg diastolic)
  5. Unstable kidney function for other reasons, e.g. macrohaematuria induced acute kidney injury
  6. Age <14 years old
  7. Secondary IgA nephropathy: e.g. due to lupus, liver cirrhosis, Henoch-Schonlein purpura
  8. Patients who are unlikely to comply with the study protocol in the view of the treating physician -
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01560052

Contacts
Contact: Vlado Perkovic +61299934500 vperkovic@george.org.au

  Hide Study Locations
Locations
Australia, New South Wales
Concord Repatriation and General Hospital Recruiting
Concord, New South Wales, Australia, 2139
Principal Investigator: Mona Razivian         
Royal North Shore Hospital Recruiting
St Leonards, New South Wales, Australia, 2065
Principal Investigator: Bruce Cooper, Dr         
Liverpool Hospital Active, not recruiting
Sydney, New South Wales, Australia, 2170
Australia, Queensland
Princess Alexandra Hosptial Recruiting
Woolloongabba, Queensland, Australia, 4102
Principal Investigator: David Johnson, Professor         
Australia, South Australia
Royal Adelaide Hospital Recruiting
Adelaide, South Australia, Australia, 5000
Principal Investigator: Chen Auh Peh         
Australia, Victoria
Royal Melbourne Hospital Recruiting
Melbourne, Victoria, Australia, 3052
Contact    61 3 9342 7119      
Principal Investigator: A/Professor K Nicholls         
China, Beijing
Chinese PLA General Hospital Recruiting
Beijing, Beijing, China
Principal Investigator: Guangyan Cai         
China, Guangdong
Guangdong Province People's Hosptial Recruiting
Guangzhou, Guangdong, China
Principal Investigator: Wei Shi         
First Affiliated Hospital, Sun Yat-Sen University Recruiting
Guangzhou, Guangdong, China, 510080
Principal Investigator: Xueqing Yu         
Peking University Shenzhen Hospital Recruiting
Shenzhen, Guangdong, China, 518036
Principal Investigator: Qiong Luo         
China, Hebei
The Second Hospital of Hebei Medical University Recruiting
Shijiazhuang, Hebei, China, 050005
Principal Investigator: Shuxia Fu         
The Third Hospital of Hebei Medical University Recruiting
Shijiazhuang, Hebei, China, 050051
Principal Investigator: Ying Li         
China, Henan
First Affiliated Hospital of Henan University of Science &Technology Recruiting
Luoyang, Henan, China, 471003
Principal Investigator: Zhiling Guo         
Henan Provincial People's Hospital Recruiting
Zhengzhou, Henan, China, 450003
Principal Investigator: Bing Liu         
The First Affiliated Hospital of Zhengzhou University Recruiting
Zhengzhou, Henan, China, 450052
Principal Investigator: Zhangsuo Liu         
China, Hubei
Renmin Hospital, Wuhan University Recruiting
Wuhan, Hubei, China, 430060
Principal Investigator: Guohua Ding         
Tongji Hospital of Huazhong University of Science and Technology Recruiting
Wuhan, Hubei, China, 430022
Principal Investigator: Gang Xu         
Union Hospital,Tongji Medical College,Huazhong University of Science and Technology Recruiting
Wuhan, Hubei, China, 430022
Principal Investigator: Jianshe Liu         
China, Inner Mongolia
First Affiliated Hospital of Inner Mongolia, Baotou Medical College Recruiting
Baotou, Inner Mongolia, China, 014010
Principal Investigator: Caili Wang         
Inner Mongolia People's Hospital Recruiting
Hohhot, Inner Mongolia, China, 010017
Principal Investigator: Li Gong         
China, Jiangsu
First Affiliated Hospital of Nanjing Medical University (Jiangsu Province Hospital) Not yet recruiting
Nanjing, Jiangsu, China, 210029
Principal Investigator: Changying Xing         
Nanjing General Hospital of Nanjing Military Command Recruiting
Nanjing, Jiangsu, China, 210002
Principal Investigator: Haitao Zhang         
Zhong Da Hospital, Southeast University Not yet recruiting
Nanjing, Jiangsu, China, 210009
Principal Investigator: Bi-Cheng Liu         
China, Jilin
Fourth Hospital Affiliated to Jilin University (FAW General Hospital) Recruiting
Changchun, Jilin, China, 130011
Principal Investigator: Xiaoxuan Zhang         
Fourth Hospital, affiliated to Jili University FAW Gen eral Hospital Recruiting
Changchun, Jilin, China
Contact: Zhang Xiaoxuan         
Principal Investigator: Zhang Xiaoxuan, Dr         
China, Liaoning
First Affiliated Hospital of Dalian Medical University Recruiting
Dalian, Liaoning, China, 116011
Principal Investigator: Hongli Lin         
Shengjing Hospital Of China Medical University Recruiting
Shengyang, Liaoning, China
Principal Investigator: Detian Li         
China, Shandong
Qilu Hospital of Shandong University Recruiting
Jinan, Shandong, China, 250012
Principal Investigator: Zhao Hu         
Jinan Military General Hospital Recruiting
Jinan, Shandong, China
Principal Investigator: Aiping Zhang         
Qianfoshan Hospital Affiliated to Shandong University Recruiting
Jinan, Shandong, China, 250014
Principal Investigator: Dongmei Xu         
Provincial Hospital Affliated to Shandong University Recruiting
Jinan, Shandong, China, 250021
Principal Investigator: Rong Wang         
Yantai Yuhuangding Hospital Recruiting
Yantai, Shandong, China, 264000
Principal Investigator: Peng Li         
China, Shanxi
The Second Affiliated Hospital of Shanxi Medical University Recruiting
Taiyuan, Shanxi, China, 030001
Principal Investigator: Rongshan Li         
China, Sichuan
Sichuan Academy of Medical Science & Sichuan Provincial People's Hospital Recruiting
Chengdu, Sichuan, China, 610072
Principal Investigator: Li Wang         
West China Hospital of Sichuan University Recruiting
Chengdu, Sichuan, China, 610041
Principal Investigator: Ping Fu         
China, Zhejiang
The First Affiliated Hospital of Zhejiang University of Medicine Recruiting
Hangzhou, Zhejiang, China, 310003
Principal Investigator: Jianghua Chen         
Hangzhou Chinese Medicine Hospital Recruiting
Hangzhou, Zhejiang, China
Principal Investigator: Hongyu Chen         
Ningbo Urinary Kidney Disease Hospital Recruiting
Ningbo, Zhejiang, China
Principal Investigator: Beiyan Bao         
Zhejiang Provincal Peoples Hospital Recruiting
Sangzhou, Zhejiang, China
Principal Investigator: Qiang He         
China
Beijing Anzhen Hospital affiliated to Beijing Capital Medical University Recruiting
Beijing, China, 100029
Principal Investigator: Yipu Chen         
Beijing Hospital of the Ministry of Health Recruiting
Beijing, China, 100730
Principal Investigator: Hua Wu         
Beijing University Third Hospital Recruiting
Beijing, China
Principal Investigator: Yue Wang         
Peking University First Hospital Recruiting
Beijing, China, 100034
Principal Investigator: Jicheng Lv         
Peking University People's Hospital Recruiting
Beijing, China, 100035
Principal Investigator: Mei Wang         
XinQiao Hospital, Third Military Medical University Recruiting
Chongqing, China, 400037
Principal Investigator: Jinhong Zhao         
Huashan Hospital Affiliated to Fudan University Recruiting
Shanghai, China, 200040
Principal Investigator: Fuming Lu         
Renji Hospital, Shanghai Jiaotong University School of Medicine Recruiting
Shanghai, China, 200001
Principal Investigator: Zhaohui Ni         
Ruijin Hospital, Shanghai Jiaotong University, School of Medicine Recruiting
Shanghai, China, 200025
Principal Investigator: Nan Chen         
The Chinese People's Liberation Army Shanghai 85th Hospital Withdrawn
Shanghai, China, 200052
Hong Kong
Queen Mary Hospital Active, not recruiting
Hong Kong, Hng Kong, Hong Kong
Kwong Wah Hospital Active, not recruiting
Kowloon, Hong Kong
Princess Margaret Hospital Active, not recruiting
Kowloon, Hong Kong
Sponsors and Collaborators
The George Institute
Peking University First Hospital
Investigators
Principal Investigator: Haiyan Wang Peking University
Principal Investigator: Vlado Perkovic The George Institute
  More Information

No publications provided

Responsible Party: The George Institute
ClinicalTrials.gov Identifier: NCT01560052     History of Changes
Other Study ID Numbers: GI-R-01-2011
Study First Received: March 15, 2012
Last Updated: March 4, 2015
Health Authority: China: Ethics Committee

Keywords provided by The George Institute:
end stage kidney disease
IgA nephropathy

Additional relevant MeSH terms:
Glomerulonephritis
Glomerulonephritis, IGA
Autoimmune Diseases
Immune System Diseases
Kidney Diseases
Nephritis
Urologic Diseases
Angiotensin-Converting Enzyme Inhibitors
Methylprednisolone
Methylprednisolone Hemisuccinate
Methylprednisolone acetate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Central Nervous System Agents
Enzyme Inhibitors
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Neuroprotective Agents
Peripheral Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on March 26, 2015