A Phase 3 interventional study of supportive therapy with: ACE-inhibitor / ARB / Statin and supportive and immunosuppressive therapy in IgA Nephropathy, sponsored by RWTH Aachen University. Completed at 34 sites in Germany. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2015-09-22.
Sponsored by RWTH Aachen University · Phase 3, Interventional, and Treatment
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).
3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.
This study's planned enrollment of 148 is above the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.
Browse Kidney Diseases studies →RWTH Aachen University is the lead sponsor of 228 studies on the registry; 19 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Proteinuria above 0.75 g/day within 12 weeks prior to or at the first visit in the run-in phase (month -6)and presence of at least one further risk factor for the development of end stage renal disease
Exclusion Criteria:
Contraindication for immunosuppressive therapy, like
Drug: supportive therapy with: ACE-inhibitor / ARB / Statin
Drug: supportive and immunosuppressive therapy
* 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
This study is completed, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.
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RWTH Aachen University