NCT01403389

A Study of the Activity of Eculizumab for Prevention of Delayed Graft Function In Deceased Donor Kidney Transplant

Terminated Phase 2 Last updated 6 May 2019

What this trial tests

Phase 2 trial testing Eculizumab in Delayed Function of Renal Transplant in 8 participants. Terminated before completion.

Timeline

1 December 2011

Primary endpoint
6 August 2013

6 February 2014

Quick facts

Lead sponsor	Schroppel, Bernd, M.D.
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	prevention
Enrollment	8
Start date	1 December 2011
Primary completion	6 August 2013
Estimated completion	6 February 2014
Sites	1 location across United States

Drugs / interventions tested

• Eculizumab (ECULIZUMAB) — full drug profile →
• Placebo

Conditions studied

• Delayed Function of Renal Transplant — all drugs for Delayed Function of Renal Transplant →

Sponsor

Schroppel, Bernd, M.D.

Who can join

18 and older, any sex, with Delayed Function of Renal Transplant. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study is to determine if Eculizumab is safe and effective in the prevention of delayed graft function following deceased donor kidney transplantation.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Complement, a target for therapy in inflammatory and degenerative diseases.
   Morgan BP, Harris CL. · · 2015 · cited 346× · PMID 26493766 · DOI 10.1038/nrd4657
2. Molecules Great and Small: The Complement System.
   Mathern DR, Heeger PS. · · 2015 · cited 203× · PMID 25568220 · DOI 10.2215/cjn.06230614
3. Complement System and the Kidney: Its Role in Renal Diseases, Kidney Transplantation and Renal Cell Carcinoma.
   Lasorsa F, Rutigliano M, Milella M, Ferro M, et al · · 2023 · cited 69× · PMID 38003705 · DOI 10.3390/ijms242216515
4. Complement as a multifaceted modulator of kidney transplant injury.
   Cravedi P, Heeger PS. · · 2014 · cited 68× · PMID 24892709 · DOI 10.1172/jci72273
5. Ischemia-Reperfusion Injury in Kidney Transplantation: Mechanisms and Potential Therapeutic Targets.
   Lasorsa F, Rutigliano M, Milella M, d'Amati A, et al · · 2024 · cited 35× · PMID 38673917 · DOI 10.3390/ijms25084332
6. Complement regulation of T-cell alloimmunity.
   Cravedi P, van der Touw W, Heeger PS. · · 2013 · cited 35× · PMID 24161041 · DOI 10.1016/j.semnephrol.2013.08.007
7. Inhibition of complement improves graft outcome in a pig model of kidney autotransplantation.
   Delpech PO, Thuillier R, SaintYves T, Danion J, et al · · 2016 · cited 33× · PMID 27663514 · DOI 10.1186/s12967-016-1013-7
8. Complement Inhibitor CRIg/FH Ameliorates Renal Ischemia Reperfusion Injury via Activation of PI3K/AKT Signaling.
   Hu C, Li L, Ding P, Li L, et al · · 2018 · cited 31× · PMID 30429287 · DOI 10.4049/jimmunol.1800987