Trial Outcomes & Findings for Eculizumab to Prevent Antibody-mediated Rejection in ABO Blood Group Incompatible Living Donor Kidney Transplantation (NCT NCT01095887)

NCT ID: NCT01095887

Last Updated: 2015-07-20

Results Overview

• Recruitment status: TERMINATED
• Study phase: PHASE1/PHASE2
• Target enrollment: 6 participants
• Primary outcome timeframe: 3 months after kidney transplant surgery
• Results posted on: 2015-07-20

Participant Flow

Subjects were enrolled from May 2010 to September 2012 at the Mayo Clinic in Rochester, Minnesota.

Participant milestones

Measure	Eculizumab Eculizumab was given on Day 0, day 1, and weekly for the first four weeks after transplant. Eculizumab: Subjects received eculizumab intravenously at the time of transplant, on the day after transplant, then weekly for four weeks. At four weeks post transplant, anti-blood group antibody levels were determined. Subjects may have potentially received eculizumab every two weeks for one year depending on antibody levels.
Overall Study STARTED	6
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Eculizumab to Prevent Antibody-mediated Rejection in ABO Blood Group Incompatible Living Donor Kidney Transplantation

Baseline characteristics by cohort

Measure	Eculizumab n=6 Participants Eculizumab was given on Day 0, day 1, and weekly for the first four weeks after transplant. Eculizumab: Subjects received eculizumab intravenously at the time of transplant, on the day after transplant, then weekly for four weeks. At four weeks post transplant, anti-blood group antibody levels were determined. Subjects may have potentially received eculizumab every two weeks for one year depending on antibody levels.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Region of Enrollment United States	6 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months after kidney transplant surgery

Outcome measures

Measure	Eculizumab n=6 Participants Eculizumab was given on Day 0, day 1, and weekly for the first four weeks after transplant.
Number of Subjects With Antibody-Mediated Rejection (AMR) Within 3 Months of Kidney Transplant Yes	2 participants
Number of Subjects With Antibody-Mediated Rejection (AMR) Within 3 Months of Kidney Transplant No	4 participants

Adverse Events

Eculizumab

Serious events: 5 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	Eculizumab n=6 participants at risk Eculizumab was given on Day 0, day 1, and weekly for the first four weeks after transplant. Eculizumab: Subjects received eculizumab intravenously at the time of transplant, on the day after transplant, then weekly for four weeks. At four weeks post transplant, anti-blood group antibody levels were determined. Subjects may have potentially received eculizumab every two weeks for one year depending on antibody levels.
Cardiac disorders Prolonged hospitalization	16.7% 1/6 • Number of events 1 • Adverse events were collected and recorded at each subject interface, up to one year after transplant.
Renal and urinary disorders Native kidney mass	16.7% 1/6 • Number of events 1 • Adverse events were collected and recorded at each subject interface, up to one year after transplant.
Renal and urinary disorders Native Nephrectomy	16.7% 1/6 • Number of events 1 • Adverse events were collected and recorded at each subject interface, up to one year after transplant.
Gastrointestinal disorders Partial small bowel obstruction	33.3% 2/6 • Number of events 2 • Adverse events were collected and recorded at each subject interface, up to one year after transplant.
Renal and urinary disorders Elevated creatinine	33.3% 2/6 • Number of events 2 • Adverse events were collected and recorded at each subject interface, up to one year after transplant.
Surgical and medical procedures Splenectomy	16.7% 1/6 • Number of events 1 • Adverse events were collected and recorded at each subject interface, up to one year after transplant.
Cardiac disorders Hyperkalemia	16.7% 1/6 • Number of events 1 • Adverse events were collected and recorded at each subject interface, up to one year after transplant.
Cardiac disorders Elevated T- Waves	16.7% 1/6 • Number of events 1 • Adverse events were collected and recorded at each subject interface, up to one year after transplant.
Gastrointestinal disorders Ogilvie's syndrome	16.7% 1/6 • Number of events 1 • Adverse events were collected and recorded at each subject interface, up to one year after transplant.
Renal and urinary disorders Allograft Nephrectomy	33.3% 2/6 • Number of events 2 • Adverse events were collected and recorded at each subject interface, up to one year after transplant.
Respiratory, thoracic and mediastinal disorders Shortness of breath	16.7% 1/6 • Number of events 1 • Adverse events were collected and recorded at each subject interface, up to one year after transplant.
Renal and urinary disorders Antibody-mediated rejection of transplant	33.3% 2/6 • Number of events 2 • Adverse events were collected and recorded at each subject interface, up to one year after transplant.
Skin and subcutaneous tissue disorders Wound dehiscence with cecal rupture	16.7% 1/6 • Number of events 1 • Adverse events were collected and recorded at each subject interface, up to one year after transplant.
Surgical and medical procedures Right hemicolectomy	33.3% 2/6 • Number of events 2 • Adverse events were collected and recorded at each subject interface, up to one year after transplant.
Surgical and medical procedures Wound debridement	16.7% 1/6 • Number of events 1 • Adverse events were collected and recorded at each subject interface, up to one year after transplant.
Cardiac disorders Myocardial infarction	16.7% 1/6 • Number of events 1 • Adverse events were collected and recorded at each subject interface, up to one year after transplant.
Blood and lymphatic system disorders Anemia	16.7% 1/6 • Number of events 1 • Adverse events were collected and recorded at each subject interface, up to one year after transplant.
Blood and lymphatic system disorders Thrombocytopenia	16.7% 1/6 • Number of events 1 • Adverse events were collected and recorded at each subject interface, up to one year after transplant.
Blood and lymphatic system disorders Platelet dysfunction	16.7% 1/6 • Number of events 1 • Adverse events were collected and recorded at each subject interface, up to one year after transplant.
Renal and urinary disorders Thrombotic microangiopathy	16.7% 1/6 • Number of events 1 • Adverse events were collected and recorded at each subject interface, up to one year after transplant.
Infections and infestations Pulmonary Blastomycosis	16.7% 1/6 • Number of events 1 • Adverse events were collected and recorded at each subject interface, up to one year after transplant.

Other adverse events

Measure	Eculizumab n=6 participants at risk Eculizumab was given on Day 0, day 1, and weekly for the first four weeks after transplant. Eculizumab: Subjects received eculizumab intravenously at the time of transplant, on the day after transplant, then weekly for four weeks. At four weeks post transplant, anti-blood group antibody levels were determined. Subjects may have potentially received eculizumab every two weeks for one year depending on antibody levels.
Cardiac disorders Atrial Fibrillation	16.7% 1/6 • Number of events 2 • Adverse events were collected and recorded at each subject interface, up to one year after transplant.
Blood and lymphatic system disorders Anemia	16.7% 1/6 • Number of events 1 • Adverse events were collected and recorded at each subject interface, up to one year after transplant.
Surgical and medical procedures High-volume serous drainage from surgery incision site	16.7% 1/6 • Number of events 1 • Adverse events were collected and recorded at each subject interface, up to one year after transplant.
Infections and infestations Wound infection	16.7% 1/6 • Number of events 1 • Adverse events were collected and recorded at each subject interface, up to one year after transplant.
Surgical and medical procedures Lymphocele	16.7% 1/6 • Number of events 1 • Adverse events were collected and recorded at each subject interface, up to one year after transplant.
General disorders Debilitation	16.7% 1/6 • Number of events 1 • Adverse events were collected and recorded at each subject interface, up to one year after transplant.

Additional Information

Dr. Mark D. Stegall

Mayo Clinic

Phone: 507-266-2812

Email: stegall.mark@mayo.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place