* 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.
The best treatment of glomerular diseases of the kidney is currently not well defined. This study aims to answer if in patients with IgA nephropathy, the most common type of glomerulonephritis an immunosuppressive treatment (with the use of steroids and chemotherapy) added to a supportive treatment is more effective than a supportive treatment alone (with the use of drugs lowering the blood pressure and the urinary protein loss).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
148
* 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
Patients reaching full clinical remission of their disease
Time frame: at the end of the 3 year study period.
GFR loss of 15 ml/min or higher from baseline GFR
Time frame: at the end of the 3 year study period
-Absolute GFR-change.
Time frame: at the end of the 3 years study period
GFR loss >=30 ml/min from baseline GFR
Time frame: at the end of the 3 year study period
-Onset of end stage renal disease.
Time frame: at the end of the 3 years study period
Mean annual change in one over serum creatinine concentration
Time frame: at the end of the 3 years study period
Proteinuria at 12 and 36 months
Time frame: 12 and 36 months
Disappearance of microhematuria
Time frame: at the end of the 3 years study period
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...and 24 more locations