Prevention of Delayed Graft Function Using Eculizumab Therapy (PROTECT Study) (NCT02145182) | Clinical Trial Compass
CompletedPhase 2/3
Prevention of Delayed Graft Function Using Eculizumab Therapy (PROTECT Study)
United States288 participantsStarted 2014-08-21
Plain-language summary
The purpose of this study was to determine if eculizumab is safe and could be used to prevent delayed graft function (DGF) following kidney transplantation.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male or female, 18 years or older
* Has dialysis-dependent renal failure (initiated more than 2 months prior to transplant)
* Participant is to receive a first kidney transplant from a standard criteria donor or expanded criteria donor deceased donor with a DGF risk score using the Irish scale of ≥25% (to be determined prior to surgery and before randomization)
* Able to provide written informed consent
* Willing and able to comply with the requirements of the study protocol
* Female participants of child-bearing potential must have a negative serum pregnancy test (serum beta-human chorionic gonadotropin) and must be practicing an effective, reliable, and medically approved contraceptive regimen at the time of consent and for up to 5 months following discontinuation of treatment
Exclusion Criteria:
* Participant to receive a multi-organ transplant
* Participant to receive kidney(s) from donors \<6 years of age
* Participant to receive a dual kidney transplant (from same donor, including en bloc)
* Participant to receive a living donor kidney
* Participant is highly sensitized (high risk to develop acute antibody-mediated rejection) to the donor (as determined by local center practice). Testing to determine high risk may include but is not limited to flow cytometric cross match, single antigen bead testing and/or complement dependent cytotoxicity
* Participant has received a previous transplant
* Participant is participating in another investigational …
What they're measuring
1
Percentage Of Participants With Delayed Graft Function (DGF) In The First Seven Days Post-transplant