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

Primary Purpose

IgA Glomerulonephritis

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
methylprednisolone
Placebo
Sponsored by
The George Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for IgA Glomerulonephritis focused on measuring end stage kidney disease, IgA nephropathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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: 30 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 <18 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.

Sites / Locations

  • Concord Repatriation and General Hospital
  • Nepean Hospital
  • Royal North Shore Hospital
  • Royal Adelaide Hospital
  • Royal Melbourne Hospital
  • University of Calgary/Alberta Health Services
  • University of Alberta Hospitals
  • St Pauls Hospital
  • St. Joseph's Healthcare
  • London Health Sciences Centre
  • Sunnybrook Health Sciences Centre
  • Toronto General Hospital,
  • Hôpital Maisonneuve-Rosemont
  • Chinese PLA General Hospital (301 Hospital)
  • The First Affiliated Hospital, Sun Yat-Sen University
  • Guangdong Provincial People's Hospital, Guangzhou
  • Peking University Shenzhen Hospital
  • The Second Hospital of Hebei Medical University
  • The Third Hospital of Hebei Medical University
  • The First Affiliated Hospital of Henan University of Science &Technology
  • Henan Provincial People's Hospital
  • The First Affiliated Hospital of Zhengzhou University
  • ongji Hospital, Tongji Medical College, Huazhong University of Science & Technology
  • Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
  • Renmin Hospital, Wuhan University
  • The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology,
  • Inner Mongolia People's Hospital
  • General Hospital of Eastern Theater Command
  • The First Affiliated Hospital with Nanjing Medical University
  • Jilin Province FAW General Hospital [Jilin University Fourth Hospital]
  • he First Affiliated Hospital of Dalian Medical University, Dalian
  • Shengjing Hospital Of China Medical University
  • Qilu Hospital of Shandong University
  • The First Affiliated Hospital of Shangdong First Medical University,Shangdong Provincial Qianfoshin
  • Shandong Provincial Hospital
  • Jinan Military General Hospital
  • Yantai Yuhuangding Hospital
  • he Second Hospital of Shanxi Medical University, Taiyuan
  • West China Hospital of Sichuan University
  • Sichuan Academy of Medical Science, Sichuan Provincial People's Hospital
  • The First Affiliated Hospital, Zhejiang University of Medicine
  • Hangzhou Hospital of Traditional Chinese Medicine,
  • Ningbo Urology & Nephrology Hospital
  • Zhejiang Provincial People's Hospital
  • Beijing Anzhen Hospital, Capital Medical University
  • Peking University First Hospital
  • Peking University People's Hospital
  • Beijing Hospital
  • Peking University Third Hospital
  • XinQiao Hospital, Third Military Medical University
  • Renji Hospital, Shanghai Jiaotong University School of Medicine
  • Ruijin Hospital, Shanghai Jiaotong University, School of Medicine
  • Huashan Hospital, Medical Centre of Fudan University
  • Princess Margaret Hospital
  • Osmania General Hospital
  • Nizam's Institute of Medical Science
  • Calicut Medical College
  • Post Graduate Institue of Medical Education and Reasearch
  • Madras Medical College
  • Sanjay Gandhi Post Graduate Institute of Medical Science
  • Hospital Sultanah Aminah
  • Hospital Kuala Lumpur
  • Hospital Tuanku Jaafar Seremban
  • Hospital Raja Permaisuri Bainun
  • Hospital Umum Sarawak
  • University Malaysia Medical Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

oral methylprednisolone

placebo

Arm Description

oral methylprednisolone Original Cohort: Methylprednisolone group; start at 0.8mg/kg/day with a maximal 48mg/kg/day x 2months, taper by 8mg/day every month with optimal blood pressure control and full dose of ACE inhibitors or ARBs as recommended by guidelines. Low Dose Cohort: Methylprednisolone group; start at 0.4mg /kg/day with a maximal dose of 32mg/day and a minimum dose of 24mg/day, reducing over 6-9months. All participants will also receive standard guideline based care, without steroid therapy. Prophylactic trimethoprim/sulfamethoxazole (a single strength tablet daily or half a double strength tablet daily) will be used during the first 3 months in the low-dose cohort, after randomisation, for the prevention of severe PJP infection, unless there is a documented sulfa allergy.

Original Cohort: Matching placebo; Optimal blood pressure control and full dose of ACE inhibitors or ARBs as recommended by guidelines; Low Dose Cohort; Matching placebo: Optimal blood pressure control and full dose of ACE inhibitors or ARBs as recommended by guidelines. All participants will also receive standard guideline based care, without steroid therapy. Prophylactic trimethoprim/sulfamethoxazole (a single strength tablet daily or half a double strength tablet daily) will be used during the first 3 months in the low-dose cohort, after randomisation, for the prevention of severe PJP infection, unless there is a documented sulfa allergy

Outcomes

Primary Outcome Measures

Progressive kidney failure
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.
primary outcome for low dose cohort
Change in proteinuria from baseline at 6 and 12 months Mean change in eGFR at 6 and 12 months

Secondary Outcome Measures

The composite of ESKD, 30% decrease in eGFR and all cause death
The composite of ESKD 40% decrease in eGFR and all cause death
The composite of ESKD 50% decrease in eGFR and all cause death
Annual eGFR decline rate
Each ESKD , death due to kidney disease and all cause death
Time averaged proteinuria post-randomisation

Full Information

First Posted
March 15, 2012
Last Updated
September 21, 2021
Sponsor
The George Institute
Collaborators
Peking University First Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01560052
Brief Title
Therapeutic Evaluation of Steroids in IgA Nephropathy Global Study (TESTING Low Dose Study)
Acronym
TESTING
Official Title
Therapeutic Evaluation of Steroids in IgA Nephropathy Global Study Low Dose Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
May 5, 2012 (Actual)
Primary Completion Date
July 23, 2021 (Actual)
Study Completion Date
July 23, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The George Institute
Collaborators
Peking University First Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study will evaluate the long-term efficacy and safety of low dose oral methylprednisolone compared to matching placebo, 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.
Detailed Description
IgA glomerulonephritis is the most common primary glomerulonephritis, and immunosuppression with steroids has been suggested to be a potential protective therapy, although the benefits and risks have not been clearly established. The TESTING study was established to compare the effects of oral methylprednisolone 0.8 mg/kg/day weaning over 6-8 months, to matching placebo on the risk of kidney failure events, using a double-blind, randomised, controlled design. After the randomisation of 262 participants to the TESTING an imbalance in serious adverse events was noted between the methylprednisolone and placebo arms of the trial by the Data Monitoring Committee, mostly due to infection. As the data also suggested likely benefit on kidney outcomes, a further 240 participants will be randomised to methylprednisolone 0.4 mg/kg/day compared to matching placebo (The TESTING low-dose group). Oral sulfamethoxazole/trimethoprim will also be provided to reduce the risk of infection All participants will undergo long term follow-up until at least 160 primary outcome events are observed (expected to be an average of at least 4 years), and the effects of steroids on the risk of the composite kidney outcome will be assessed on the study population as a whole, stratified for treatment regimen so long as there is no evidence of significant heterogeneity in the efficacy at reducing the primary outcome. Each of the original and the low-dose cohorts in TESTING will also have separate power to detect reductions in proteinuria and effects on average eGFR, along with effects on important safety outcomes with the steroid regimens used.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
IgA Glomerulonephritis
Keywords
end stage kidney disease, IgA nephropathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
503 (Actual)

8. Arms, Groups, and Interventions

Arm Title
oral methylprednisolone
Arm Type
Active Comparator
Arm Description
oral methylprednisolone Original Cohort: Methylprednisolone group; start at 0.8mg/kg/day with a maximal 48mg/kg/day x 2months, taper by 8mg/day every month with optimal blood pressure control and full dose of ACE inhibitors or ARBs as recommended by guidelines. Low Dose Cohort: Methylprednisolone group; start at 0.4mg /kg/day with a maximal dose of 32mg/day and a minimum dose of 24mg/day, reducing over 6-9months. All participants will also receive standard guideline based care, without steroid therapy. Prophylactic trimethoprim/sulfamethoxazole (a single strength tablet daily or half a double strength tablet daily) will be used during the first 3 months in the low-dose cohort, after randomisation, for the prevention of severe PJP infection, unless there is a documented sulfa allergy.
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
Original Cohort: Matching placebo; Optimal blood pressure control and full dose of ACE inhibitors or ARBs as recommended by guidelines; Low Dose Cohort; Matching placebo: Optimal blood pressure control and full dose of ACE inhibitors or ARBs as recommended by guidelines. All participants will also receive standard guideline based care, without steroid therapy. Prophylactic trimethoprim/sulfamethoxazole (a single strength tablet daily or half a double strength tablet daily) will be used during the first 3 months in the low-dose cohort, after randomisation, for the prevention of severe PJP infection, unless there is a documented sulfa allergy
Intervention Type
Drug
Intervention Name(s)
methylprednisolone
Other Intervention Name(s)
Medrol
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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
Primary Outcome Measure Information:
Title
Progressive kidney failure
Description
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.
Time Frame
1-6 years
Title
primary outcome for low dose cohort
Description
Change in proteinuria from baseline at 6 and 12 months Mean change in eGFR at 6 and 12 months
Time Frame
1 year
Secondary Outcome Measure Information:
Title
The composite of ESKD, 30% decrease in eGFR and all cause death
Time Frame
1-6 years
Title
The composite of ESKD 40% decrease in eGFR and all cause death
Time Frame
1-6 years
Title
The composite of ESKD 50% decrease in eGFR and all cause death
Time Frame
1-6 years
Title
Annual eGFR decline rate
Time Frame
1-6 years
Title
Each ESKD , death due to kidney disease and all cause death
Time Frame
1-6 years
Title
Time averaged proteinuria post-randomisation
Time Frame
1-6 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: IgA nephropathy proven on renal biopsy. 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. eGFR: 30 to 120ml/min per 1.73m²(inclusive) while receiving maximum tolerated RAS blockade Exclusion Criteria: 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. 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. Systemic immunosuppressive therapy in the previous year. Malignant /uncontrolled hypertension (>160mm systolic or 110mmHg diastolic) Current unstable kidney function for other reasons, e.g. macrohaematuria induced acute kidney injury Age <18 years old Secondary IgA nephropathy: e.g. due to lupus, liver cirrhosis, Henoch- Schonlein purpura Patients who are unlikely to comply with the study protocol in the view of the treating physician.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hong Zhang
Organizational Affiliation
Peking University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Vlado Perkovic
Organizational Affiliation
The George Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Concord Repatriation and General Hospital
City
Concord
State/Province
New South Wales
ZIP/Postal Code
2139
Country
Australia
Facility Name
Nepean Hospital
City
Kingswood
State/Province
New South Wales
ZIP/Postal Code
2747
Country
Australia
Facility Name
Royal North Shore Hospital
City
St Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Royal Melbourne Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3052
Country
Australia
Facility Name
University of Calgary/Alberta Health Services
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2R 0X7
Country
Canada
Facility Name
University of Alberta Hospitals
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
Facility Name
St Pauls Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 1Y6
Country
Canada
Facility Name
St. Joseph's Healthcare
City
Hamiliton
State/Province
Ontario
ZIP/Postal Code
L8N 4A6
Country
Canada
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Toronto General Hospital,
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2N2
Country
Canada
Facility Name
Hôpital Maisonneuve-Rosemont
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Facility Name
Chinese PLA General Hospital (301 Hospital)
City
Beijing
State/Province
Beijing
Country
China
Facility Name
The First Affiliated Hospital, Sun Yat-Sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Facility Name
Guangdong Provincial People's Hospital, Guangzhou
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
Peking University Shenzhen Hospital
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518036
Country
China
Facility Name
The Second Hospital of Hebei Medical University
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050005
Country
China
Facility Name
The Third Hospital of Hebei Medical University
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050051
Country
China
Facility Name
The First Affiliated Hospital of Henan University of Science &Technology
City
Luoyang
State/Province
Henan
ZIP/Postal Code
471003
Country
China
Facility Name
Henan Provincial People's Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450003
Country
China
Facility Name
The First Affiliated Hospital of Zhengzhou University
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450052
Country
China
Facility Name
ongji Hospital, Tongji Medical College, Huazhong University of Science & Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Facility Name
Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Facility Name
Renmin Hospital, Wuhan University
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430060
Country
China
Facility Name
The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology,
City
Baotou
State/Province
Inner Mongolia
ZIP/Postal Code
014010
Country
China
Facility Name
Inner Mongolia People's Hospital
City
Hohhot
State/Province
Inner Mongolia
ZIP/Postal Code
010017
Country
China
Facility Name
General Hospital of Eastern Theater Command
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210002
Country
China
Facility Name
The First Affiliated Hospital with Nanjing Medical University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
Facility Name
Jilin Province FAW General Hospital [Jilin University Fourth Hospital]
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130011
Country
China
Facility Name
he First Affiliated Hospital of Dalian Medical University, Dalian
City
Dalian
State/Province
Liaoning
ZIP/Postal Code
116011
Country
China
Facility Name
Shengjing Hospital Of China Medical University
City
Shengyang
State/Province
Liaoning
Country
China
Facility Name
Qilu Hospital of Shandong University
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250012
Country
China
Facility Name
The First Affiliated Hospital of Shangdong First Medical University,Shangdong Provincial Qianfoshin
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250014
Country
China
Facility Name
Shandong Provincial Hospital
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250021
Country
China
Facility Name
Jinan Military General Hospital
City
Jinan
State/Province
Shandong
Country
China
Facility Name
Yantai Yuhuangding Hospital
City
Yantai
State/Province
Shandong
ZIP/Postal Code
264000
Country
China
Facility Name
he Second Hospital of Shanxi Medical University, Taiyuan
City
Taiyuan
State/Province
Shanxi
ZIP/Postal Code
030001
Country
China
Facility Name
West China Hospital of Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Facility Name
Sichuan Academy of Medical Science, Sichuan Provincial People's Hospital
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610072
Country
China
Facility Name
The First Affiliated Hospital, Zhejiang University of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
Facility Name
Hangzhou Hospital of Traditional Chinese Medicine,
City
Hangzhou
State/Province
Zhejiang
Country
China
Facility Name
Ningbo Urology & Nephrology Hospital
City
Ningbo
State/Province
Zhejiang
Country
China
Facility Name
Zhejiang Provincial People's Hospital
City
Sangzhou
State/Province
Zhejiang
Country
China
Facility Name
Beijing Anzhen Hospital, Capital Medical University
City
Beijing
ZIP/Postal Code
100029
Country
China
Facility Name
Peking University First Hospital
City
Beijing
ZIP/Postal Code
100034
Country
China
Facility Name
Peking University People's Hospital
City
Beijing
ZIP/Postal Code
100035
Country
China
Facility Name
Beijing Hospital
City
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
Peking University Third Hospital
City
Beijing
Country
China
Facility Name
XinQiao Hospital, Third Military Medical University
City
Chongqing
ZIP/Postal Code
400037
Country
China
Facility Name
Renji Hospital, Shanghai Jiaotong University School of Medicine
City
Shanghai
ZIP/Postal Code
200001
Country
China
Facility Name
Ruijin Hospital, Shanghai Jiaotong University, School of Medicine
City
Shanghai
ZIP/Postal Code
200025
Country
China
Facility Name
Huashan Hospital, Medical Centre of Fudan University
City
Shanghai
ZIP/Postal Code
200040
Country
China
Facility Name
Princess Margaret Hospital
City
Kowloon
Country
Hong Kong
Facility Name
Osmania General Hospital
City
Hyderabad
State/Province
Andhra Pradesh
ZIP/Postal Code
500012
Country
India
Facility Name
Nizam's Institute of Medical Science
City
Hyderabad
State/Province
Andhra Pradesh
ZIP/Postal Code
500082,
Country
India
Facility Name
Calicut Medical College
City
Kozhikode
State/Province
Kerala
ZIP/Postal Code
673008,
Country
India
Facility Name
Post Graduate Institue of Medical Education and Reasearch
City
Chandigarh
State/Province
Punjab
ZIP/Postal Code
160 012
Country
India
Facility Name
Madras Medical College
City
Chen
State/Province
Tamil Nadu
ZIP/Postal Code
600037
Country
India
Facility Name
Sanjay Gandhi Post Graduate Institute of Medical Science
City
Lucknow
State/Province
Uttar Pradesh
ZIP/Postal Code
226014
Country
India
Facility Name
Hospital Sultanah Aminah
City
Johor Bahru
State/Province
Johor
ZIP/Postal Code
80100
Country
Malaysia
Facility Name
Hospital Kuala Lumpur
City
Kuala Lumpur
State/Province
Kulala Lumpur
ZIP/Postal Code
50586
Country
Malaysia
Facility Name
Hospital Tuanku Jaafar Seremban
City
Seremban
State/Province
Negri Seremban
ZIP/Postal Code
70300
Country
Malaysia
Facility Name
Hospital Raja Permaisuri Bainun
City
Ipoh
State/Province
Perak
ZIP/Postal Code
30990
Country
Malaysia
Facility Name
Hospital Umum Sarawak
City
Kuching
State/Province
Samarahan
ZIP/Postal Code
93586
Country
Malaysia
Facility Name
University Malaysia Medical Centre
City
Kuala Lumpur
ZIP/Postal Code
59100
Country
Malaysia

12. IPD Sharing Statement

Citations:
PubMed Identifier
35579642
Citation
Lv J, Wong MG, Hladunewich MA, Jha V, Hooi LS, Monaghan H, Zhao M, Barbour S, Jardine MJ, Reich HN, Cattran D, Glassock R, Levin A, Wheeler DC, Woodward M, Billot L, Stepien S, Rogers K, Chan TM, Liu ZH, Johnson DW, Cass A, Feehally J, Floege J, Remuzzi G, Wu Y, Agarwal R, Zhang H, Perkovic V; TESTING Study Group. Effect of Oral Methylprednisolone on Decline in Kidney Function or Kidney Failure in Patients With IgA Nephropathy: The TESTING Randomized Clinical Trial. JAMA. 2022 May 17;327(19):1888-1898. doi: 10.1001/jama.2022.5368.
Results Reference
derived
PubMed Identifier
28763548
Citation
Lv J, Zhang H, Wong MG, Jardine MJ, Hladunewich M, Jha V, Monaghan H, Zhao M, Barbour S, Reich H, Cattran D, Glassock R, Levin A, Wheeler D, Woodward M, Billot L, Chan TM, Liu ZH, Johnson DW, Cass A, Feehally J, Floege J, Remuzzi G, Wu Y, Agarwal R, Wang HY, Perkovic V; TESTING Study Group. Effect of Oral Methylprednisolone on Clinical Outcomes in Patients With IgA Nephropathy: The TESTING Randomized Clinical Trial. JAMA. 2017 Aug 1;318(5):432-442. doi: 10.1001/jama.2017.9362.
Results Reference
derived
PubMed Identifier
26032537
Citation
Yeo SC, Liew A, Barratt J. Emerging therapies in immunoglobulin A nephropathy. Nephrology (Carlton). 2015 Nov;20(11):788-800. doi: 10.1111/nep.12527.
Results Reference
derived

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

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