At a glance
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Supportive Versus Immunosuppressive Therapy for the Treatment Of Progressive IgA Nephropathy
In Brief
A Phase 3 clinical trial evaluating supportive therapy with: ACE-inhibitor / ARB / Statin and supportive and immunosuppressive therapy for IgA Nephropathy. Completed, enrolled 148 participants across 34 sites.
Detailed Summary
* Evaluation of the efficacy of an immunosuppressive therapy added to a comprehensive supportive therapy to induce a clinical remission in patients at risk for progressive IgAN * Investigation of differences between the treatments regarding the number of patients loosing more than 15 ml/min of GFR.
Study Details
Timeline
Interventions
* Antihypertensive therapy with a target blood pressure below 125/75 mmHg (following current clinical guidelines). * ACE-inhibitors (ARB when an ACE-inhibitor is not tolerated) * Other antihypertensive medications depending on the clinical decision and following current guidelines. * Statin therapy * Dietary counseling for a low-sodium diet and, if GFR is below 60 ml/min, for a protein intake of 0.8 g/kg/day.
* supportive therapy as outlined above * depending on GFR: * methylprednisolone and prednisolone * cyclophosphamide and prednisolone; after 3 months azathioprine with prednisolone * Concomitant medication with the immunosuppressive treatment following current clinical practice