PLEASE NOTE: This study has been imported from ClinicalTrials.gov without additional data checks.

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1 PLEASE NOTE: This study has been imported from ClinicalTrials.gov without additional data checks. Trial Description Title Supportive Versus Immunosuppressive Therapy for the Treatment Of Progressive IgA Nephropathy Trial Acronym STOP-IgAN URL of the trial [---]* Brief Summary in Lay Language - 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. Brief Summary in Scientific Language 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). Organizational Data DRKS-ID: DRKS Page 1 of 7

2 DRKS-ID: DRKS Investigator Sponsored/Initiated Trial (IST/IIT): yes Ethics Approval/Approval of the Ethics Committee: [---]* (leading) Ethics Committee Nr.: [---]* Secondary IDs Primary Registry-ID: NCT (ClinicalTrials.gov) Sponsor-ID: STOP-IgAN (RWTH Aachen University) Health condition or Problem studied Free text: IgA Nephropathy ICD10: N Recurrent and persistent haematuria; Other Interventions/Observational Groups Arm 1: Drug: supportive therapy with: ACE-inhibitor / ARB / Statin Arm 2: Drug: supportive and immunosuppressive therapy Characteristics Study Type: Interventional Study Type Non-Interventional: [---]* Allocation: Randomized controlled trial Blinding: [---]* Who is blinded: [---]* Control: Active control Purpose: Treatment Assignment: Parallel Phase: III Off-label use (Zulassungsüberschreitende Anwendung eines Arzneimittels): [---]* Page 2 of 7

3 Primary Outcome - 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 Secondary Outcome - -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 Countries of recruitment DE Germany Locations of Recruitment Medical Clinic II, University Hospital Aachen, Aachen 2. Medizinische Klinik, Nephrologie, Klinikum Augsburg, Augsburg Campus Charité Mitte, Medizinische Klinik - Schwerpunkt Nephrologie, Centrum 13, Berlin St. Joseph Krankenhaus Medizinische Klinik II, Berlin Charité Campus Virchow-Klinikum, Medizinische Klinik / Nephrologie, Berlin Helios-Klinikum Berlin-Buch, Nephrologie Charité CCB, Berlin Klinikum Bremen-Mitte, Medizinische Klinik III, Bremen Universitätsklinikum Dresden, Medizinische Klinik III, Bereich Nephrologie, Dresden Universitätsklinikum Düsseldorf, Klinik für Nephrologie, Düsseldorf Universitätsklinikum Erlangen, Medizinische Klinik IV, Erlangen Universitätsklinikum Essen, Klinik für Nieren- und Hochdruckkrankheiten, Essen Universitätsklinikum Freiburg, Innere Medizin IV, Freiburg Page 3 of 7

4 Universitätsklinikum Gießen und Marburg GmbH, Medizinische Klinik und Poliklinik II, Gießen Universitätsklinikum Göttingen, Zentrum Innere Medizin, Abteilung für Nephrologie und Rheumatologie, Göttingen Universitätsklinikum Hamburg-Eppendorf, 3. Medizinische Klinik und Poliklinik, Hamburg Medizinische Hochschule Hannover, Abteilung Nephrologie, Hannover Med. Universitätsklinik Heidelberg, Nierenzentrum Heidelberg, Sektion Nephrologie, Heidelberg Universitätsklinikum Jena, Medizinische Klinik III, Jena Westpfalz-Klinikum GmbH, Abteilung für Nephrologie und Transplantationsmedizin, Kaiserslautern Uniklinik Köln, Klinik IV für Innere Medizin, Nephrologie und Allgemeine Innere Medizin, Köln Universitätsklinikum Magdeburg, Klinik für Nephrologie, Zentrum für Innere Medizin, Magdeburg Dialysezentrum am Brand, Mainz Universitätsklinikum Mannheim, V. Medizinische Klinik, Mannheim Universitätsklinikum Marburg, Klinik für Innere Medizin, Schwerpunkt Nephrologie, Marburg Klinikum rechts der Isar, Medizinische Klinik II, Abteilung für Nephrologie, München Klinikum der LMU, Nephrologisches Zentrum, München KfH Nierenzentrum, München Universitätsklinikum Münster, Medizinische Klinik und Poliklinik D, Münster Universitätsklinikum Regensburg, Klinik und Poliklinik für Innere Medizin II, Regensburg Krankenhaus der Barmherzigen Brüder, Abteilung Innere Medizin II, Trier Universitätsklinikum Tübingen, Medizinische Klinik IV, Sektion für Nieren- und Hochdruckkrankheiten, Tübingen Dialyse-Zentrum Dres.med. PD H. Reichel, Th. Weinreich u. C., Villingen- Schwenningen Zentrum für Nieren- und Hochdruckkrankheiten, Wiesbaden Universitätsklinik Würzburg, Medizinische Klinik und Poliklinik I, Würzburg Recruitment Planned/Actual: [---]* (Anticipated or Actual) Date of First Enrollment: 2008/02/27 Target Sample Size: 148 Monocenter/Multicenter trial: Multicenter trial National/International: [---]* Page 4 of 7

5 Inclusion Criteria Gender: Both, male and female Minimum Age: 18 Years Maximum Age: 70 Years Additional Inclusion Criteria - Male or female patients from years with histologically proven primary IgAN with typical mesangioproliferative features. Diagnosis has to be made by a neuropathologist. - 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 1. arterial hypertension, defined as ambulatory blood pressure >140/90 mm Hg or the use of antihypertensive medication or 2. impaired renal function, defined as creatinine clearance or estimated GFR <90 ml/min. Exclusion criteria - Known allergy or intolerance to study medication (except in case of ACEinhibitor, in which case a change to an angiotensin receptor blocker is possible). - Women who are pregnant or breastfeeding and women without sufficient contraception. - Any prior immunosuppressive therapy. - Variants of primary IgAN (e.g. rapidly progressive IgAN with crescents in >50% of glomeruli or minimal change GN with glomerular IgA deposits). - Significant liver dysfunction (more than three fold increased GPT compared to norm) - Contraindication for immunosuppressive therapy, like patients - acute or chronic infectious disease incl. hepatitis and HIV positive - any malignancy - leukocytopenia, thrombocytopenia or known allergy against Page 5 of 7

6 prednisolone, cyclophosphamide or azathioprine - active intestinal bleeding, active gastric or duodenal ulcer - Need of permanent immunosuppression, (e.g. transplanted patients, steroid-dependent inflammatory diseases) - Secondary IgAN or diseases associated with glomerular deposits of IgA. - Additional other chronic renal disease. - Creatinine clearance below 30 ml/min (mean of 3 measurements). - Alcohol or drug abuse - Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study - Subject unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study trial - Participation in a parallel clinical trial or participation in another clinical within the last 3 months. - Subjects who are in any state of dependency to the sponsor or the investigators. - Employees of the sponsor or the investigators. - Subjects who have been committed to an institution by legal or regulatory order. Addresses Primary Sponsor RWTH Aachen University Contact for Scientific Queries Medical Clinic II, University Hospital Aachen Juergen Floege, Prof. Dr. Page 6 of 7

7 Contact for Scientific Queries Medical Clinic II, University Hospital Aachen Juergen Floege, Prof. Dr. Contact for Public Queries Medical Clinic II, University Hospital Aachen Juergen Floege, Prof. Dr. Sources of Monetary or Material Support [---]* Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor Status Recruitment Status: Recruiting complete, follow-up continuing Study Closing (LPLV): [---]* Trial Publications, Results and other documents Further trial documents Study Homepage The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs. - Translation on version: 1 - Last processed date by ClinicalTrials.gov: 2014/07/16 * This entry means the parameter is not applicable or has not been set.