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University of Groningen Evaluation of renal end points in nephrology trials Weldegiorgis, Misghina Tekeste

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University of Groningen

Evaluation of renal end points in nephrology trials

Weldegiorgis, Misghina Tekeste

IMPORTANT NOTE: You are advised to consult the publisher's version (publisher's PDF) if you wish to cite from it. Please check the document version below.

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Publication date: 2017

Link to publication in University of Groningen/UMCG research database

Citation for published version (APA):

Weldegiorgis, M. T. (2017). Evaluation of renal end points in nephrology trials. University of Groningen.

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Evaluation of renal end points in

nephrology trials

PhD thesis

to obtain the degree of PhD at the University of Groningen

on the authority of the Rector Magnificus Prof. dr. E. Sterken

and in accordance with the decision by the College of Deans. This thesis will be defended in public on Wednesday 8 November 2017 at 16.15 hours

by

Misghina Tekeste Weldegiorgis born on 27 February 1986

in Harer, Ethiopia

Evaluation of renal end points in

nephrology trials

PhD thesis

to obtain the degree of PhD at the University of Groningen

on the authority of the Rector Magnificus Prof. dr. E. Sterken

and in accordance with the decision by the College of Deans. This thesis will be defended in public on Wednesday 8 November 2017 at 16.15 hours

by

Misghina Tekeste Weldegiorgis born on 27 February 1986

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Financial support for the printing of this thesis was kindly provided by the University of Groningen, University Medical Center Groningen, and Graduate School for Drug Exploration (GUIDE).

© Misghina Tekeste Weldegiorgis, Groningen, the Netherlands 2017 Cover design: Nynke Visser

Layout: Misghina T. Weldegiorgis

Printed by: GVO drukkers & vormgevers B.V ISBN: 978-94-034-0154-6 (printed version)

978-94-034-0153-9 (digital version)

Copyright by Misghina Tekeste Weldegiorgis, Groningen, the Netherlands. All rights reserved. No part of this publication may be reproduced, stored on a retrieval system, or transmitted in any form by any means, without permission of the author.

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Financial support for the printing of this thesis was kindly provided by the University of Groningen, University Medical Center Groningen, and Graduate School for Drug Exploration (GUIDE).

© Misghina Tekeste Weldegiorgis, Groningen, the Netherlands 2017 Cover design: Nynke Visser

Layout: Misghina T. Weldegiorgis

Printed by: GVO drukkers & vormgevers B.V ISBN: 978-94-034-0154-6 (printed version)

978-94-034-0153-9 (digital version)

Copyright by Misghina Tekeste Weldegiorgis, Groningen, the Netherlands. All rights reserved. No part of this publication may be reproduced, stored on a retrieval system, or transmitted in any form by any means, without permission of the author.

Evaluation of renal end points in

nephrology trials

PhD thesis

to obtain the degree of PhD at the University of Groningen

on the authority of the Rector Magnificus Prof. dr. E. Sterken

and in accordance with the decision by the College of Deans. This thesis will be defended in public on Wednesday 8 November 2017 at 16.15 hours

by

Misghina Tekeste Weldegiorgis born on 27 February 1986

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Promotors: Prof. Dr. D. de Zeeuw

Prof. Dr. H.J. Lambers Heerspink

Assessment Committee: Prof. Dr. B. Flamion Prof. Dr. S. J. L. Bakker Prof. Dr. R.T. Gansevoort Promotors

Prof. dr. H.J. Lambers Heerspink Prof. dr. D. de Zeeuw Assessment Committee Prof. dr. R.T. Gansevoort Prof. dr. S.J.L. Bakker Prof. dr. H.G.M. Leufkens Promotors

Prof. dr. H.J. Lambers Heerspink Prof. dr. D. de Zeeuw Assessment Committee Prof. dr. R.T. Gansevoort Prof. dr. S.J.L. Bakker Prof. dr. H.G.M. Leufkens Promotors

Prof. dr. H.J. Lambers Heerspink Prof. dr. D. de Zeeuw Assessment Committee Prof. dr. R.T. Gansevoort Prof. dr. S.J.L. Bakker Prof. dr. H.G.M. Leufkens Promotors

Prof. dr. H.J. Lambers Heerspink Prof. dr. D. de Zeeuw Assessment Committee Prof. dr. R.T. Gansevoort Prof. dr. S.J.L. Bakker Prof. dr. H.G.M. Leufkens Promotors

Prof. dr. H.J. Lambers Heerspink Prof. dr. D. de Zeeuw Assessment Committee Prof. dr. R.T. Gansevoort Prof. dr. S.J.L. Bakker Prof. dr. H.G.M. Leufkens Paranymphs: K.P.J. Smits S.T. de Vries

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Paranymphs: K.P.J. Smits S.T. de Vries

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Table of contents

Chapter 1 Introduction and aim of the thesis 8 Adapted from Current Opinion in Nephrology and Hypertension 2015 May;24(3):284-9

Chapter 2 Progressive renal function loss, a straight line? Longitudinal eGFR 19 trajectories in patients with and without type 2 diabetes and nephropathy American Journal of Kidney Diseases, In Press

Chapter 3 Slope of glomerular filtration rate as clinical trial end point 46 Submitted

Chapter 4 Estimated GFR decline as a surrogate end point for kidney failure 59 American Journal of Kidney Diseases 2014 Feb;63(2):244-50

Chapter 5 Is chronic dialysis the right hard renal end point to evaluate 80 renoprotective drug effects?

Clinical Journal of the American Society of Nephrology, In Press

Chapter 6 Summary and future perspectives 99

Nederlandse samenvatting en toekomstperspectief 107

Acknowledgments 116

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Table of contents

Chapter 1 Introduction and aim of the thesis 8 Adapted from Current Opinion in Nephrology and Hypertension 2015 May;24(3):284-9

Chapter 2 Progressive renal function loss, a straight line? Longitudinal eGFR 19 trajectories in patients with and without type 2 diabetes and nephropathy American Journal of Kidney Diseases, In Press

Chapter 3 Slope of glomerular filtration rate as clinical trial end point 46 Submitted

Chapter 4 Estimated GFR decline as a surrogate end point for kidney failure 59 American Journal of Kidney Diseases 2014 Feb;63(2):244-50

Chapter 5 Is chronic dialysis the right hard renal end point to evaluate 80 renoprotective drug effects?

Clinical Journal of the American Society of Nephrology, In Press

Chapter 6 Summary and future perspectives 99

Nederlandse samenvatting en toekomstperspectief 107

Acknowledgments 116 Curriculum Vitae 120 9 21 47 61 83 103 111 121 126 125

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___________________________________________________________________________

Chapter 1

Introduction and aim

Adapted from: Current Opinion in Nephrology and Hypertension 2015 May;24(3):284-9

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