GSK- ASCEND-D / ASCEND-ND

Prüfplancode: 200808 
EUDRA CT: 2016-000542-65  Phase IIIA

Prüfplancode: 200807  
EUDRA CT: 2016-000541-31  Phase IIIA

Compound Number:

• GSK1278863
• GSK1278863

ASCEND-ND (200808):

A phase 3 randomized, open-label (sponsor-blind), active-controlled, parallel-group, multi-center, event driven study in non-dialysis subjects with anemia associated and chronic kidney disease to evaluate the safety and efficacy of daprodustat compared to darbepoetin alfa.

ASCEND-D (200807):

A phase 3 randomized, open-label (sponsor-blind), activecontrolled, parallel-group, multi-center, event driven study in dialysis subjects with anemia associated and chronic kidney disease to evaluate the safety and efficacy of daprodustat compared to recombinant human erythropoietin, following a switch from erythropoietin-stimulating agents.

Sponsor:

GlaxoSmithKline GmbH & Co.KG; UK

Start: Mai 2017

PI: PD Dr. med. U. Benck
SI: Dr. med. M. Mircheva, PD Dr. med. A. Kälsch

Protokoll Nummer: CD-0018

Prospective, multi-center study to evaluate the everlinQ endoAVF System when used to create an endovascular arteriovenous fistula (endoAVF) for patients who require vascular access for hemodialysis.

Sponsor:

TVA Medical, Inc., USA

Start: Februar 2016

PI:  PD Dr. med. U. Benck
SI : PD Dr. med. A. Kälsch

Protocol ISN: 506-MA-1002

European Multicentre Kidney Transplant Advagraf Conversion Registry. A non-interventional post-autorisation study (PAS).

Sponsor:

Astellas Pharma Europe Ltd.

Start: Januar 2015

PI: Prof. Dr. med. B. Krämer
SI: Prof. Dr. med. B. Krüger

Prüfplancode: PMR – EC – 1213
EUDRA CT : N/A Phase IV

A long-term follow-up of adult kidney and liver allograft recipients previously enrolled into a Tacrolimus (Advagraf) Trial. A multicenter, non-interventional, post authorization study (PAS).

Sponsor:

Astellas Pharma Europe B. V. Niederlande

Start: September 2014

PI: Prof. Dr. med. B. Krüger

Studiencode: SolKiD

Untersuchung der körperlichen und psychosozialen Folgen nach Lebendnieren-Spende; Eine multizentrische Kohortenstudie ( Safty of Living Kidney Donors).

Sponsor:

Westfälische Wilhelms Universität, Medizinische Fakultät Münster

Start: März 2014

PI: Prof. Dr. med. Bernd Krüger

Prüfplancode: IM103-116
EUDRA CT: 2012-001314-42 Phase II

Evaluation of the Benefits and Risks in Maintenance Renal Transplant Recipients Following Conversion to Nulojix (belatacept)-based Immunosuppression.

Sponsor:

Bristol-Myers Squibb

Start: September 2013

PI: Prof. Dr. med. B. Krüger
SI: PD Dr. med. U. Benck

A cohorte study of patients with diabetes mellitus type 2 Studie zur Erforschung möglicher Ursachen der Nierenbeteiligung bei Patienten mit Diabetes mellitus Typ2.

Sponsor:

KfH-Stiftung-Präventivmedizin e.V.

Start:
Ende:

PI: Prof. Dr. med. Krämer
SI: Dr. med. A.Lammert