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IgA GlomerulonephritisTESTINGNCT01560052

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

A study testing methylprednisolone in people with IgA Glomerulonephritis, run by The George Institute at 66 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
IgA Glomerulonephritis
What is being tested?
methylprednisolone
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
503 participants
Where
66 sitesin 6 countries
Study dates
5 May 2012to 23 Jul 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 12Show fewer
  • 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.

Trial locations and contacts

66 sites in 6 countries.

66 sites in 6 countries

China40 sites

  • The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology,

    Baotou, Inner Mongolia, 014010

  • Chinese PLA General Hospital (301 Hospital)

    Beijing, Beijing Municipality

  • Beijing Anzhen Hospital, Capital Medical University

    Beijing, 100029

  • Peking University First Hospital

    Beijing, 100034

  • Peking University People's Hospital

    Beijing, 100035

  • Beijing Hospital

    Beijing, 100730

  • Peking University Third Hospital

    Beijing

  • Jilin Province FAW General Hospital [Jilin University Fourth Hospital]

    Changchun, Jilin, 130011

  • West China Hospital of Sichuan University

    Chengdu, Sichuan, 610041

  • Sichuan Academy of Medical Science, Sichuan Provincial People's Hospital

    Chengdu, Sichuan, 610072

  • XinQiao Hospital, Third Military Medical University

    Chongqing, 400037

  • he First Affiliated Hospital of Dalian Medical University, Dalian

    Dalian, Liaoning, 116011

  • The First Affiliated Hospital, Sun Yat-Sen University

    Guangzhou, Guangdong, 510080

  • Guangdong Provincial People's Hospital, Guangzhou

    Guangzhou, Guangdong

  • The First Affiliated Hospital, Zhejiang University of Medicine

    Hangzhou, Zhejiang, 310003

  • Hangzhou Hospital of Traditional Chinese Medicine,

    Hangzhou, Zhejiang

  • Inner Mongolia People's Hospital

    Hohhot, Inner Mongolia, 010017

  • Qilu Hospital of Shandong University

    Jinan, Shandong, 250012

  • The First Affiliated Hospital of Shangdong First Medical University,Shangdong Provincial Qianfoshin

    Jinan, Shandong, 250014

  • Shandong Provincial Hospital

    Jinan, Shandong, 250021

  • Jinan Military General Hospital

    Jinan, Shandong

  • The First Affiliated Hospital of Henan University of Science &Technology

    Luoyang, Henan, 471003

  • General Hospital of Eastern Theater Command

    Nanjing, Jiangsu, 210002

  • The First Affiliated Hospital with Nanjing Medical University

    Nanjing, Jiangsu, 210029

  • Ningbo Urology & Nephrology Hospital

    Ningbo, Zhejiang

  • Zhejiang Provincial People's Hospital

    Sangzhou, Zhejiang

  • Renji Hospital, Shanghai Jiaotong University School of Medicine

    Shanghai, 200001

  • Ruijin Hospital, Shanghai Jiaotong University, School of Medicine

    Shanghai, 200025

  • Huashan Hospital, Medical Centre of Fudan University

    Shanghai, 200040

  • Shengjing Hospital Of China Medical University

    Shengyang, Liaoning

  • Peking University Shenzhen Hospital

    Shenzhen, Guangdong, 518036

  • The Second Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050005

  • The Third Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050051

  • he Second Hospital of Shanxi Medical University, Taiyuan

    Taiyuan, Shanxi, 030001

  • ongji Hospital, Tongji Medical College, Huazhong University of Science & Technology

    Wuhan, Hubei, 430022

  • Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei, 430022

  • Renmin Hospital, Wuhan University

    Wuhan, Hubei, 430060

  • Yantai Yuhuangding Hospital

    Yantai, Shandong, 264000

  • Henan Provincial People's Hospital

    Zhengzhou, Henan, 450003

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450052

Other trials in China

Canada8 sites

  • University of Calgary/Alberta Health Services

    Calgary, Alberta, T2R 0X7

  • University of Alberta Hospitals

    Edmonton, Alberta, T6G 2B7

  • St. Joseph's Healthcare

    Hamiliton, Ontario, L8N 4A6

  • London Health Sciences Centre

    London, Ontario, N6A 5A5

  • Hôpital Maisonneuve-Rosemont

    Montreal, Quebec, H1T 2M4

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

  • Toronto General Hospital,

    Toronto, Ontario, M5G 2N2

  • St Pauls Hospital

    Vancouver, British Columbia, V6Z 1Y6

Other trials in Canada

India6 sites

  • Post Graduate Institue of Medical Education and Reasearch

    Chandigarh, Punjab, 160 012

  • Madras Medical College

    Chen, Tamil Nadu, 600037

  • Osmania General Hospital

    Hyderabad, Andhra Pradesh, 500012

  • Nizam's Institute of Medical Science

    Hyderabad, Andhra Pradesh, 500082,

  • Calicut Medical College

    Kozhikode, Kerala, 673008,

  • Sanjay Gandhi Post Graduate Institute of Medical Science

    Lucknow, Uttar Pradesh, 226014

Other trials in India

Malaysia6 sites

  • Hospital Raja Permaisuri Bainun

    Ipoh, Perak, 30990

  • Hospital Sultanah Aminah

    Johor Bahru, Johor, 80100

  • Hospital Kuala Lumpur

    Kuala Lumpur, Kulala Lumpur, 50586

  • University Malaysia Medical Centre

    Kuala Lumpur, 59100

  • Hospital Umum Sarawak

    Kuching, Samarahan, 93586

  • Hospital Tuanku Jaafar Seremban

    Seremban, Negri Seremban, 70300

Other trials in Malaysia

Australia5 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • Concord Repatriation and General Hospital

    Concord, New South Wales, 2139

  • Nepean Hospital

    Kingswood, New South Wales, 2747

  • Royal Melbourne Hospital

    Melbourne, Victoria, 3052

  • Royal North Shore Hospital

    St Leonards, New South Wales, 2065

Other trials in Australia

Hong Kong1 site

  • Princess Margaret Hospital

    Kowloon

Other trials in Hong Kong

About this study

Official title: Therapeutic Evaluation of Steroids in IgA Nephropathy Global Study Low Dose Study

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.

Read the 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.

Being tested
methylprednisolone, Placebo
Keywords
end stage kidney disease, IgA nephropathy
Medical subject headings
Glomerulonephritis, IGA, Kidney Failure, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • methylprednisoloneDrug

    Also called Medrol

    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.

  • PlaceboDrug

    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

Study groups in NCT01560052
Study groupRoleWhat they receive
oral methylprednisoloneActive comparatororal 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.
Receives: Drug: methylprednisolone
placeboPlacebo comparatorOriginal 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
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 1-6 years

  2. 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

    Measured: 1 year

Secondary outcomes (6)

  1. The composite of ESKD, 30% decrease in eGFR and all cause death

    Measured: 1-6 years

  2. The composite of ESKD 40% decrease in eGFR and all cause death

    Measured: 1-6 years

  3. The composite of ESKD 50% decrease in eGFR and all cause death

    Measured: 1-6 years

  4. Annual eGFR decline rate

    Measured: 1-6 years

  5. Each ESKD , death due to kidney disease and all cause death

    Measured: 1-6 years

  6. Time averaged proteinuria post-randomisation

    Measured: 1-6 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Mar 2012 (estimated)
  2. Study start5 May 2012
  3. Primary completion23 Jul 2021
  4. Study completion23 Jul 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
503 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01560052
Sponsor's protocol ID
GI-R-01-2011
Acronym
TESTING
Status last verified
Sep 2021
First submitted
15 Mar 2012
Last updated
23 Sep 2021
Results posted
No
Data monitoring committee
Yes

Publications

  • Wang L, He Y, Tian W, Wang J, Shi S, Liu L, Monaghan H, Wong MG, Lv J, Chen Y, Zhang Y, Zhang H. Glucocorticoid-Modulated Molecular Signatures and Prediction of Treatment Efficacy in IgA Nephropathy. J Am Soc Nephrol. 2026 Jul 31. doi: 10.1681/ASN.0000001208. Online ahead of print.

    PubMed 42536435

  • Howie AJ, Lalayiannis AD. The Oxford Classification Should Remain the Gold Standard for Classification of IgA Nephropathy: CON. Kidney360. 2026 Oct 1;7(10):2382-2384. doi: 10.34067/KID.0000001083. Epub 2026 Feb 9. No abstract available.

    PubMed 41661687

  • Xu LL, Zhou XJ, Bi W, Zhang P, Shi SF, Liu LJ, Lv JC, Zhang H. Genetic Determinants of Steroid Responsiveness in IgA Nephropathy. J Am Soc Nephrol. 2026 Jun 1;37(6):1248-1260. doi: 10.1681/ASN.0000000977. Epub 2025 Dec 11.

    PubMed 41563292

  • 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.

    PubMed 35579642

  • 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.

    PubMed 28763548

  • 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.

    PubMed 26032537

Questions about this trial

What is this clinical trial studying?

A study testing methylprednisolone in people with IgA Glomerulonephritis, run by The George Institute at 66 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 66 sites in China, Canada, India, Malaysia, Australia and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progressive kidney failure (time frame: 1-6 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01560052, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2021.

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