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: February 12, 2014
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 Active, not recruiting
Concord, New South Wales, Australia, 2139
Australia, South Australia
Royal Adelaide Hospital Recruiting
Adelaide, South Australia, Australia, 5000
Principal Investigator: Chen Auh Peh         
China, Beijing
Chinese PLA General Hospital Not yet recruiting
Beijing, Beijing, China
Principal Investigator: Guangyan Cai         
China, Guangdong
First Affiliated Hospital, Sun Yat-Sen University Not yet recruiting
Guangzhou, Guangdong, China, 510080
Principal Investigator: Xueqing Yu         
Guangdong Province People's Hosptial Not yet recruiting
Guangzhou, Guangdong, China
Principal Investigator: Wei Shi         
Peking University Shenzhen Hospital Not yet recruiting
Shenzhen, Guangdong, China, 518036
Principal Investigator: Qiong Luo         
China, Hebei
The Third Hospital of Hebei Medical University Not yet recruiting
Shijiazhuang, Hebei, China, 050051
Principal Investigator: Ying Li         
The Second Hospital of Hebei Medical University Not yet recruiting
Shijiazhuang, Hebei, China, 050005
Principal Investigator: Shuxia Fu         
China, Henan
First Affiliated Hospital of Henan University of Science &Technology Not yet recruiting
Luoyang, Henan, China, 471003
Principal Investigator: Zhiling Guo         
Henan Provincial People's Hospital Not yet recruiting
Zhengzhou, Henan, China, 450003
Principal Investigator: Bing Liu         
The First Affiliated Hospital of Zhengzhou University Not yet recruiting
Zhengzhou, Henan, China, 450052
Principal Investigator: Zhangsuo Liu         
China, Hubei
Union Hospital,Tongji Medical College,Huazhong University of Science and Technology Not yet recruiting
Wuhan, Hubei, China, 430022
Principal Investigator: Jianshe Liu         
Tongji Hospital of Huazhong University of Science and Technology Not yet recruiting
Wuhan, Hubei, China, 430022
Principal Investigator: Gang Xu         
Renmin Hospital, Wuhan University Not yet recruiting
Wuhan, Hubei, China, 430060
Principal Investigator: Guohua Ding         
China, Inner Mongolia
First Affiliated Hospital of Inner Mongolia, Baotou Medical College Not yet recruiting
Baotou, Inner Mongolia, China, 014010
Principal Investigator: Caili Wong         
Inner Mongolia People's Hospital Not yet 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 Not yet 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) Not yet recruiting
Changchun, Jilin, China, 130011
Principal Investigator: Xiaoxuan Zhang         
China, Liaoning
First Affiliated Hospital of Dalian Medical University Not yet recruiting
Dalian, Liaoning, China, 116011
Principal Investigator: Hongli Lin         
Shengjing Hospital Of China Medical University Not yet recruiting
Shengyang, Liaoning, China
Principal Investigator: Detian Li         
China, Shandong
Jinan Military General Hospital Recruiting
Jinan, Shandong, China
Principal Investigator: Aiping Zhang         
Provincial Hospital Affliated to Shandong University Not yet recruiting
Jinan, Shandong, China, 250021
Principal Investigator: Rong Wang         
Qianfoshan Hospital Affiliated to Shandong University Not yet recruiting
Jinan, Shandong, China, 250014
Principal Investigator: Dongmei Xu         
Qilu Hospital of Shandong University Not yet recruiting
Jinan, Shandong, China, 250012
Principal Investigator: Zhao Hu         
Yantai Yuhuangding Hospital Not yet recruiting
Yantai, Shandong, China, 264000
Principal Investigator: Peng Li         
China, Shanxi
The Second Affiliated Hospital of Shanxi Medical University Not yet recruiting
Taiyuan, Shanxi, China, 030001
Principal Investigator: Rongshan Li         
China, Sichuan
Sichuan Academy of Medical Science & Sichuan Provincial People's Hospital Not yet recruiting
Chengdu, Sichuan, China, 610072
Principal Investigator: Li Wang         
West China Hospital of Sichuan University Not yet recruiting
Chengdu, Sichuan, China, 610041
Principal Investigator: Ping Fu         
China, Zhejiang
Hangzhou Chinese Medicine Hospital Recruiting
Hangzhou, Zhejiang, China
Principal Investigator: Hongyu Chen         
The First Affiliated Hospital of Zhejiang University of Medicine Not yet recruiting
Hangzhou, Zhejiang, China, 310003
Principal Investigator: Jianghua Chen         
Ningbo Urinary Kidney Disease Hospital Recruiting
Ningbo, Zhejiang, China
Principal Investigator: Beiyan Bao         
Zhejiang Provincal Peoples Hospital Not yet recruiting
Sangzhou, Zhejiang, China
Principal Investigator: Qing he         
China
Peking University People's Hospital Recruiting
Beijing, China, 100035
Principal Investigator: Mei Wang         
Peking University First Hospital Recruiting
Beijing, China, 100034
Principal Investigator: Jicheng Lv         
Beijing Hospital of the Ministry of Health Not yet recruiting
Beijing, China, 100730
Principal Investigator: Hua Wu         
Beijing University Third Hospital Recruiting
Beijing, China
Principal Investigator: Yue Wang         
Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine Not yet recruiting
Beijing, China, 100700
Principal Investigator: Luying Sun         
Naval General Hospital of PLA Not yet recruiting
Beijing, China, 100037
Principal Investigator: Chunhua Zhou         
Beijing Anzhen Hospital affiliated to Beijing Capital Medical University Not yet recruiting
Beijing, China, 100029
Principal Investigator: Yipu Chen         
XiaoQiao Hospital, Third Military Medical University Not yet recruiting
Chongqing, China, 400037
Principal Investigator: Fahuan Yuan         
Huashan Hospital Affiliated to Fudan University Not yet recruiting
Shanghai, China, 200040
Principal Investigator: Fuming Lu         
Ruijin Hospital, Shanghai Jiaotong University, School of Medicine Not yet recruiting
Shanghai, China, 200025
Principal Investigator: Nan Chen         
The Chinese People's Liberation Army Shanghai 85th Hospital Not yet recruiting
Shanghai, China, 200052
Principal Investigator: Jinghong Zhang         
Renji Hospital, Shanghai Jiaotong University School of Medicine Not yet recruiting
Shanghai, China, 200001
Principal Investigator: Zhaohui Ni         
Sponsors and Collaborators
The George Institute
Peking University First Hospital
Investigators
Principal Investigator: Haiyan Wang Renal Division, Peking University First Hospital
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: February 12, 2014
Health Authority: China: Ethics Committee

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

Additional relevant MeSH terms:
Glomerulonephritis
Glomerulonephritis, IGA
Kidney Diseases
Nephritis
Urologic Diseases
Autoimmune Diseases
Immune System Diseases
Angiotensin-Converting Enzyme Inhibitors
Methylprednisolone acetate
Prednisolone acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents
Glucocorticoids

ClinicalTrials.gov processed this record on July 20, 2014