Overview

This trial is active, not recruiting.

Condition iga glomerulonephritis
Treatments methylprednisolone, placebo
Sponsor The George Institute
Collaborator Peking University First Hospital
Start date April 2012
End date June 2019
Trial size 750 participants
Trial identifier NCT01560052, GI-R-01-2011

Summary

This study will evaluate the long-term efficacy and safety of oral methylprednisolone 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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
methylprednisolone group; start at 0.6-0.8mg/kg/day with a maximal 48mg/day×2 months, taper by 8mg/day every month to stop within 6-8 months; Optimal blood pressure control and full dose of ACE inhibitors or ARBs as recommended by guidelines.
methylprednisolone Medrol
oral methylprednisolone or placebo 0.6-0.8mg/kg/day with a maximum 48mg/day x 2 months, tapered by 8mg/day every month to stop within 6-8 months. 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.
(Placebo Comparator)
Matching placebo ; Optimal blood pressure control and full dose of ACE inhibitors or ARBs as recommended by guidelines.
placebo
Matching placebo tablets; 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.

Primary Outcomes

Measure
Progressive kidney failure
time frame: 1-6 years

Secondary Outcomes

Measure
The composite of ESKD, 40% decrease in eGFR and all cause death
time frame: 1-6 years
Each of ESKD, renal death and all cause death
time frame: 1-6 years
Proteinuria remission
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

Eligibility Criteria

Male or female participants at least 14 years old.

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: 20 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 <14 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

Additional Information

Official title Therapeutic Evaluation of Steroids in IgA Nephropathy Global Study
Principal investigator Hong Zhang
Description Study outcomes - Primary outcome 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 - Secondary outcomes The composite of ESKD, 40% and 50% decrease in eGFR and all cause death; Each of ESKD, renal death and all cause death; Annual eGFR decline rate; Proteinuria remission
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by The George Institute.