Eligibility DRKS00006521 NCT00554502 IGA Nephropathy Inclusion Criteria Exclusion Criteria Known allergy or intolerance to study medication (except in case of ACE-inhibitor, in which case a change to an angiotensin receptor blocker is possible). Yes
No
Women who are pregnant or breastfeeding and women without sufficient contraception. Yes
No
Any prior immunosuppressive therapy. Yes
No
Variants of primary IgAN (e.g. rapidly progressive IgAN with crescents in >50% of glomeruli or minimal change GN with glomerular IgA deposits). Yes
No
Significant liver dysfunction (more than three fold increased GPT compared to norm) Yes
No
Contraindication for immunosuppressive therapy, like Yes
No
acute or chronic infectious disease incl. hepatitis and HIV positive patients Yes
No
Malignant Neoplasms Yes
No
leukocytopenia, thrombocytopenia or known allergy against prednisolone, cyclophosphamide or azathioprine Yes
No
active intestinal bleeding, active gastric or duodenal ulcer Yes
No
Need of permanent immunosuppression, (e.g. transplanted patients, steroid-dependent inflammatory diseases) Yes
No
Secondary IgAN or diseases associated with glomerular deposits of IgA. Yes
No
Additional other chronic renal disease. Yes
No
Creatinine clearance below 30 ml/min (mean of 3 measurements). Yes
No
Alcohol or drug abuse Yes
No
Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study Yes
No
Subject unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study Yes
No
Participation in a parallel clinical trial or participation in another clinical trial within the last 3 months. Yes
No
Subjects who are in any state of dependency to the sponsor or the investigators. Yes
No
Employees of the sponsor or the investigators. Yes
No
Subjects who have been committed to an institution by legal or regulatory order. Yes
No
