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

• Register: ClinicalTrials.gov
• Last refreshed on: 4 October 2021
• Main ID: NCT01560052
• Date of registration: 15/03/2012
• Prospective Registration: Yes
• Primary sponsor: The George Institute
• Public title: Therapeutic Evaluation of Steroids in IgA Nephropathy Global Study (TESTING Low Dose Study) TESTING
• Scientific title: Therapeutic Evaluation of Steroids in IgA Nephropathy Global Study Low Dose Study
• Date of first enrolment: May 5, 2012
• Target sample size: 503
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01560052
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Australia, Canada, China, Hong Kong, India, Malaysia

Contacts

• Name: Vlado Perkovic
• Affiliation: The George Institute

• Name: Hong Zhang
• Affiliation: Peking University

Key inclusion & exclusion 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: 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

IgA Glomerulonephritis

Intervention(s)

Drug: methylprednisolone

Drug: Placebo

Primary Outcome(s)

Progressive kidney failure [Time Frame: 1-6 years]

primary outcome for low dose cohort [Time Frame: 1 year]

Secondary Outcome(s)

Each ESKD , death due to kidney disease and all cause death [Time Frame: 1-6 years]

Time averaged proteinuria post-randomisation [Time Frame: 1-6 years]

The composite of ESKD 40% decrease in eGFR and all cause death [Time Frame: 1-6 years]

Annual eGFR decline rate [Time Frame: 1-6 years]

The composite of ESKD 50% decrease in eGFR and all cause death [Time Frame: 1-6 years]

The composite of ESKD, 30% decrease in eGFR and all cause death [Time Frame: 1-6 years]

Secondary ID(s)

GI-R-01-2011

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Peking University First Hospital