Clinical trial NCT01560052: Therapeutic Evaluation of Steroids in IgA Nephropathy Global Study (TESTING Low Dose Study)
Official title: Therapeutic Evaluation of Steroids in IgA Nephropathy Global Study Low Dose Study
Conditions: IgA Glomerulonephritis
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.
Interventions:
description: Original Cohort:<br/>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<br/>Low Dose Cohort:<br/>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.<br/>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.
name: methylprednisolone
other_name: Medrol
type: Drug
description: Intervention: Drug: Placebo<br/>Original Cohort:<br/>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.<br/>Low Dose cohort:<br/>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.<br/>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
name: Placebo
type: Drug
Study arms:
design_group_description: oral methylprednisolone<br/>Original Cohort:<br/>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.<br/>Low Dose Cohort:<br/>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.<br/>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.
design_group_title: oral methylprednisolone
design_group_type: Active Comparator
design_group_description: Original Cohort:<br/>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.<br/>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
design_group_title: placebo
design_group_type: Placebo Comparator
Sponsor: The George Institute for Global Health
Collaborators: Peking University First Hospital
Drug name mappings:
name: 甲泼尼龙
lang: CN
name: Methylprednisolone
lang: EN
name: メチルプレドニゾロン
lang: JP