Studien

Prof. Johannes Mann

Activities in Clinical trials – as of May 2012

Principal investigator (Leiter Klinische Prüfung in Germany)

• AIPRI Study (Maschio et al, NEJM 1996)
• HOPE Study (Yusuf et al, NEJM 2000)
• Darbepoietin registration study (Vanrenterghem et al, KI 2002)
• ONTARGET study (Yusuf et al NEJM 2008, Mann et al Lancet 2008)
• CERA RCT with Darbepoietin (Carrera et al, NDT 2010)
• ASCEND study with avosentan (Mann et al, JASN 2010)

Steering committee

•  AIPRI Study (Maschio, … Mann et al, NEJM 1996)
•  HOPE Study (Mann et al, Ann. Int Med, 2001, NEJM 2000)
•  DIABHYCAR Study (Marre, … Mann et al, BMJ 2004)
•  4D Study (Wanner, … Mann et al, NEJM 2005)
• ONTARGET Study (Mann et al, Lancet 2008, NEJM 2008)
• TRANSCEND Study (Mann et al, Ann Int Med 2009, Lancet 2008)
•  ASCEND Study (Mann et al, JASN 2010)
•  APOLLO Study (stopped 5-2012, Circulation 2014)
•  LEADER Study (Marso, …Mann et al NEJM 2016)

Data safety & monitoring board

•  ISAR-React, member (German Heart Center, Munich)
•  ISAR SAFE, chairman (German Heart Center, Munich)
• FLUID study, chairman (Dept. of Nephrology, McMaster University)
• SONAR study, member

Endpoint adjudication committee

All trials that are listed above as steering committee membership except DIABHYCAR and ASCEND

as well as:

•  SCOUT (NEJM 2010)
•  ORIGIN (NEJM 6-2012)
•  BEAM Study (stopped)
• HOPE-3 Study (NEJM 2016)
•  TIPS3 (ongoing)
• CARMELINA (ongoing)
•  BI_DKA Study (ongoing)
• Local principal investigator

Local principal investigator

• All trials that are listed above as steering committee membership except DIABHYCAR and ASCEND
• Phase 2 Studies with ACE inhibitors in the 90-ies
• Phase 2 Study with atrial natriuretic peptide (Wyeth), (Mann et al, NDT 1989)#
• Long-term study with CERA and CV outcomes (ongoing)
• 6-months study on iron-containing phosphate binder (ongoing)
• Anemia treatment with sotatercept (ongoing)

GCP Training Course: 21. May 2013