Overview

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

Status:
Completed
Trial end date:
2021-07-23
Target enrollment:
0
Participant gender:
All
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.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
The George Institute
Collaborator:
Peking University First Hospital
Treatments:
Angiotensin-Converting Enzyme Inhibitors
Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
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.