Overview

This trial is active, not recruiting.

Condition delayed graft function
Treatments eculizumab, placebo
Phase phase 2/phase 3
Target C5
Sponsor Alexion Pharmaceuticals
Collaborator CTI Clinical Trial and Consulting Services
Start date July 2014
End date December 2015
Trial size 286 participants
Trial identifier NCT02145182, 2013-004650-25, ECU-DGF-201

Summary

The purpose of this study is to determine if Eculizumab is safe and could be used to prevent delayed graft function following kidney transplantation.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose prevention
Arm
(Experimental)
Eculizumab will be administered by intravenous (IV) infusion over 25-45 minutes for two doses (on day of transplant then 18-24 hours later).
eculizumab soliris
Eculizumab will be administered by intravenous (IV) infusion over 25-45 minutes for two doses (on day of transplant then 18-24 hours later).
(Placebo Comparator)
Placebo will be administered by intravenous (IV) infusion over 25-45 minutes for two doses (on day of transplant then 18-24 hours later).
placebo
Placebo will be administered by intravenous (IV) infusion over 25-45 minutes for two doses (on day of transplant then 18-24 hours later).

Primary Outcomes

Measure
Incidence of DGF defined as the requirement for dialysis for any reason in the first seven days post-transplant
time frame: First 7 days post Kidney Transplant

Secondary Outcomes

Measure
Graft function categorized into delayed graft function, functional delayed graft function, and immediate graft function
time frame: During the first 7 days post-transplantation
Dialysis post-transplantation
time frame: During the first 30 days post-transplantation
Calculated eGFR (Estimated Glomerular Filtration Rate)
time frame: At day 28 post-transplantation
Rejection free graft survival
time frame: At 26 and 52 weeks post-transplantation

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Subject male or female, 18 years or older - Subject with dialysis dependent renal failure (initiated more than 2 months prior to transplant) - Subject is to receive a first kidney transplant from a SCD or ECD deceased donor with a DGF risk score using the Irish scale of ≥ 25% (to be determined prior to surgery and before randomization) - Subject able to provide written informed consent - Subject must be willing and able to comply with the requirements of the study protocol - Female subjects of child-bearing potential must have a negative serum pregnancy test (serum beta-hCG) 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: - Subject to receive a multi-organ transplant - Subject to receive kidney(s) from donors < 6 years of age - Subject to receive a dual kidney transplant (from same donor, including en bloc) - Subject to receive a living donor kidney - Subject is highly sensitized (high risk to develop acute AMR) 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 - Subject has received a previous transplant - Subject is participating in another investigational study - Subject has a body mass index (BMI) >40 kg/m2 at screening - Subject will be the recipient of an A, B, O Blood Glycoproteins (ABO)(blood type) incompatible kidney (A2 donors to B and O recipients will be allowed if the site has the ability to confirm A2 subtype) - Subject will receive a kidney from a donation after cardiac death (DCD) donor - Subject has a predicted Irish model risk of DGF < 25% - Female subjects who are pregnant or breast feeding - Female subjects of child bearing potential who are unable or unwilling to use a medically acceptable form of contraception - Subjects with a history of human immunodeficiency virus (HIV), or active hepatitis C virus (HCV) or hepatitis B virus (HBV) infection - Subjects with active bacterial or other infection which is clinically significant in the opinion of the Investigator - Subjects with a history of splenectomy - Subjects with unresolved meningococcal disease - Subjects with an unresolved systemic bacterial or fungal infection - Subjects with known or suspected hereditary complement deficiency (for example, but not limited to: aHUS, PNH) - Subject has a current malignancy or a history of any malignancy (within the past 5 years), except non-metastatic basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix that has been treated appropriately - Subject has a history of or is believed by the Investigator to have used an illicit drug(s) and/or abused alcohol within 3 months prior to screening - Subject has a psychiatric or physical illness that in the opinion of the Investigator would interfere with the ability of the subject to participate in the study

Additional Information

Official title A Randomized, Parallel-group, Double-blind, Placebo-controlled, Multi-center Study of Eculizumab for the Prevention of Delayed Graft Function After Kidney Transplantation in Adult Subjects at Increased Risk of Delayed Graft Function.
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by Alexion Pharmaceuticals.