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

This study is ongoing, but not recruiting participants.
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 30, 2016
Last verified: July 2015
  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 40% 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, 40% 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 ]
  • The composite of ESKD, 50% decrease in eGFR and all cause death [ Time Frame: 1-6 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 750
Study Start Date: April 2012
Estimated Study Completion Date: September 2019
Estimated Primary Completion Date: June 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: oral methylprednisolone
methylprednisolone group; start at 0.6-0.8mg/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 0.6-0.8mg/kg/day with a maximum 48mg/day x 2 months, tapered 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 40 % 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, 40% and 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.
  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 120ml/min per 1.73m²(inclusive) while receiving maximum tolerated RAS blockade

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. Current 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

  Hide Study Locations
Locations
Australia, New South Wales
Concord Repatriation and General Hospital
Concord, New South Wales, Australia, 2139
Royal North Shore Hospital
St Leonards, New South Wales, Australia, 2065
Liverpool Hospital
Sydney, New South Wales, Australia, 2170
Australia, Queensland
Princess Alexandra Hosptial
Woolloongabba, Queensland, Australia, 4102
Australia, South Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Australia, Victoria
Royal Melbourne Hospital
Melbourne, Victoria, Australia, 3052
China, Beijing
Chinese PLA General Hospital
Beijing, Beijing, China
China, Guangdong
First Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, China, 510080
Guangdong Province People's Hosptial
Guangzhou, Guangdong, China
Peking University Shenzhen Hospital
Shenzhen, Guangdong, China, 518036
China, Hebei
The Third Hospital of Hebei Medical University
Shijiazhuang, Hebei, China, 050051
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, China, 050005
China, Henan
First Affiliated Hospital of Henan University of Science &Technology
Luoyang, Henan, China, 471003
Henan Provincial People's Hospital
Zhengzhou, Henan, China, 450003
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450052
China, Hubei
Tongji Hospital of Huazhong University of Science and Technology
Wuhan, Hubei, China, 430022
Union Hospital,Tongji Medical College,Huazhong University of Science and Technology
Wuhan, Hubei, China, 430022
Renmin Hospital, Wuhan University
Wuhan, Hubei, China, 430060
China, Inner Mongolia
First Affiliated Hospital of Inner Mongolia, Baotou Medical College
Baotou, Inner Mongolia, China, 014010
Inner Mongolia People's Hospital
Hohhot, Inner Mongolia, China, 010017
China, Jiangsu
Nanjing General Hospital of Nanjing Military Command
Nanjing, Jiangsu, China, 210002
China, Jilin
Fourth Hospital Affiliated to Jilin University (FAW General Hospital)
Changchun, Jilin, China, 130011
Fourth Hospital, affiliated to Jili University FAW Gen eral Hospital
Changchun, Jilin, China
China, Liaoning
First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, China, 116011
Shengjing Hospital Of China Medical University
Shengyang, Liaoning, China
China, Shandong
Qianfoshan Hospital Affiliated to Shandong University
Jinan, Shandong, China, 250014
Provincial Hospital Affliated to Shandong University
Jinan, Shandong, China, 250021
Jinan Military General Hospital
Jinan, Shandong, China
Qilu Hospital of Shandong University
Jinan, Shandong, China, 250012
Yantai Yuhuangding Hospital
Yantai, Shandong, China, 264000
China, Shanxi
The Second Affiliated Hospital of Shanxi Medical University
Taiyuan, Shanxi, China, 030001
China, Sichuan
Sichuan Academy of Medical Science & Sichuan Provincial People's Hospital
Chengdu, Sichuan, China, 610072
West China Hospital of Sichuan University
Chengdu, Sichuan, China, 610041
China, Zhejiang
The First Affiliated Hospital of Zhejiang University of Medicine
Hangzhou, Zhejiang, China, 310003
Hangzhou Chinese Medicine Hospital
Hangzhou, Zhejiang, China
Ningbo Urinary Kidney Disease Hospital
Ningbo, Zhejiang, China
Zhejiang Provincal Peoples Hospital
Sangzhou, Zhejiang, China
China
Beijing University Third Hospital
Beijing, China
Peking University First Hospital
Beijing, China, 100034
Peking University People's Hospital
Beijing, China, 100035
Beijing Hospital of the Ministry of Health
Beijing, China, 100730
Beijing Anzhen Hospital affiliated to Beijing Capital Medical University
Beijing, China, 100029
XinQiao Hospital, Third Military Medical University
Chongqing, China, 400037
Renji Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, China, 200001
Ruijin Hospital, Shanghai Jiaotong University, School of Medicine
Shanghai, China, 200025
Huashan Hospital Affiliated to Fudan University
Shanghai, China, 200040
Hong Kong
Princess Margaret Hospital
Kowloon, Hong Kong
Sponsors and Collaborators
The George Institute
Peking University First Hospital
Investigators
Principal Investigator: Hong Zhang Peking University
Principal Investigator: Vlado Perkovic The George Institute
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 30, 2016
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
Autoimmune Diseases
Immune System 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 May 04, 2016