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Clinical 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01560052
Study type Interventional
Source The George Institute
Contact
Status Completed
Phase N/A
Start date May 5, 2012
Completion date July 23, 2021

See also
  Status Clinical Trial Phase
Completed NCT00004448 - Alternate Day Prednisone or Daily Fish Oil Supplements in Patients With Immunoglobulin A Nephropathy Phase 2
Completed NCT00006137 - Pilot Study of Enalapril and Renal Function in Patients With IgA Nephropathy N/A
Completed NCT02527902 - Autonomic Nervous System (ANS) and Renal Function in Immunoglobin A (IgA) Nephropathy N/A
Completed NCT00004305 - Study of Genetic Anomalies of Complement Related Proteins in Patients With IgA Glomerulonephritis N/A
Completed NCT01115426 - Inhibitors of Angiotensin II in Proteinuric Mesangioproliferative Glomerulonephritis Phase 4