Trial Outcomes & Findings for Dosing Regimen of Eculizumab Added to Conventional Treatment in Positive Crossmatch Deceased Donor Kidney Transplant (NCT NCT01106027)

Results Overview

Diagnosis of AHR will be based histological findings using Banff '05 criteria.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

2 participants

Primary outcome timeframe

1 year posttransplant

Results posted on

2018-01-31

Participant Flow

Patients were recruited from Mayo Clinic in Rochester, Minnesota.

Participant milestones

Participant milestones
Measure	Eculizumab Patients will be given 1200 mg of eculizumab intravenously over 30 minutes, 1 hour prior to surgery. Patients will be given 900 mg of eculizumab on Day 1 post-transplant. Patients will then be given 900 mg of eculizumab weekly through 4 weeks post-transplant. At week 4, patients will be assessed for donor specific anti-donor human leukocyte antigen (HLA) antibody (DSA). Patients with total DSA normalized values \<5000 will stop eculizumab treatment. Patients with total DSA normalized values \>5000 will continue eculizumab treatment every 14 days from week 5 through week 9. The dose will be increased to 1200 mg and dosing will now be every 2 weeks instead of weekly.
Overall Study STARTED	2
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Eculizumab Patients will be given 1200 mg of eculizumab intravenously over 30 minutes, 1 hour prior to surgery. Patients will be given 900 mg of eculizumab on Day 1 post-transplant. Patients will then be given 900 mg of eculizumab weekly through 4 weeks post-transplant. At week 4, patients will be assessed for donor specific anti-donor human leukocyte antigen (HLA) antibody (DSA). Patients with total DSA normalized values \<5000 will stop eculizumab treatment. Patients with total DSA normalized values \>5000 will continue eculizumab treatment every 14 days from week 5 through week 9. The dose will be increased to 1200 mg and dosing will now be every 2 weeks instead of weekly.
Overall Study Lost graft early, discontinued	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Eculizumab n=2 Participants Patients will be given 1200 mg of eculizumab intravenously over 30 minutes, 1 hour prior to surgery. Patients will be given 900 mg of eculizumab on Day 1 post-transplant. Patients will then be given 900 mg of eculizumab weekly through 4 weeks post-transplant. At week 4, patients will be assessed for donor specific anti-donor human leukocyte antigen (HLA) antibody (DSA). Patients with total DSA normalized values \<5000 will stop eculizumab treatment. Patients with total DSA normalized values \>5000 will continue eculizumab treatment every 14 days from week 5 through week 9. The dose will be increased to 1200 mg and dosing will now be every 2 weeks instead of weekly.
Age, Categorical <=18 years	0 Participants n=2 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=2 Participants
Age, Categorical >=65 years	0 Participants n=2 Participants
Sex: Female, Male Female	1 Participants n=2 Participants
Sex: Female, Male Male	1 Participants n=2 Participants
Region of Enrollment United States	2 Participants n=2 Participants

PRIMARY outcome

Timeframe: 1 year posttransplant

Population: The one subject who completed the study did not have acute humoral rejection. The other subject had the transplant but lost the graft early, meeting one of the endpoints of the study.

Diagnosis of AHR will be based histological findings using Banff '05 criteria.

Outcome measures

Outcome measures
Measure	Eculizumab n=1 Participants Patients will be given 1200 mg of eculizumab intravenously over 30 minutes, 1 hour prior to surgery. Patients will be given 900 mg of eculizumab on Day 1 post-transplant. Patients will then be given 900 mg of eculizumab weekly through 4 weeks post-transplant. At week 4, patients will be assessed for donor specific anti-donor human leukocyte antigen (HLA) antibody (DSA). Patients with total DSA normalized values \<5000 will stop eculizumab treatment. Patients with total DSA normalized values \>5000 will continue eculizumab treatment every 14 days from week 5 through week 9. The dose will be increased to 1200 mg and dosing will now be every 2 weeks instead of weekly.
Number of Subjects With Acute Humoral Rejection (AHR) up to One Year Post Transplant.	0 Participants

Adverse Events

Eculizumab

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Eculizumab n=2 participants at risk Patients will be given 1200 mg of eculizumab intravenously over 30 minutes, 1 hour prior to surgery. Patients will be given 900 mg of eculizumab on Day 1 post-transplant. Patients will then be given 900 mg of eculizumab weekly through 4 weeks post-transplant. At week 4, patients will be assessed for donor specific anti-donor human leukocyte antigen (HLA) antibody (DSA). Patients with total DSA normalized values \<5000 will stop eculizumab treatment. Patients with total DSA normalized values \>5000 will continue eculizumab treatment every 14 days from week 5 through week 9. The dose will be increased to 1200 mg and dosing will now be every 2 weeks instead of weekly.
Immune system disorders Acute antibody mediated rejection	50.0% 1/2 • Number of events 1 • 1 year
Renal and urinary disorders Allograft nephrectomy	50.0% 1/2 • Number of events 1 • 1 year

Other adverse events

Other adverse events
Measure	Eculizumab n=2 participants at risk Patients will be given 1200 mg of eculizumab intravenously over 30 minutes, 1 hour prior to surgery. Patients will be given 900 mg of eculizumab on Day 1 post-transplant. Patients will then be given 900 mg of eculizumab weekly through 4 weeks post-transplant. At week 4, patients will be assessed for donor specific anti-donor human leukocyte antigen (HLA) antibody (DSA). Patients with total DSA normalized values \<5000 will stop eculizumab treatment. Patients with total DSA normalized values \>5000 will continue eculizumab treatment every 14 days from week 5 through week 9. The dose will be increased to 1200 mg and dosing will now be every 2 weeks instead of weekly.
Cardiac disorders Presyncope	50.0% 1/2 • Number of events 1 • 1 year
Respiratory, thoracic and mediastinal disorders Shortness of breath	50.0% 1/2 • Number of events 1 • 1 year
Cardiac disorders Peripheral edema	50.0% 1/2 • Number of events 1 • 1 year
Infections and infestations Pneumonia	50.0% 1/2 • Number of events 1 • 1 year
Blood and lymphatic system disorders Anemia	50.0% 1/2 • Number of events 1 • 1 year

Additional Information

Dr. Mark Stegall

Mayo Clinic

Phone: 507-284-6275

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place