Trial Outcomes & Findings for Eculizumab to Enable Renal Transplantation in Patients With History of Catastrophic Antiphospholipid Antibody Syndrome (NCT NCT01029587)

NCT ID: NCT01029587

Last Updated: 2020-10-26

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 1 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2020-10-26

Participant Flow

Participant milestones

Measure	Eculizumab Patients will receive eculizumab in conjunction with systemic anticoagulation before and after kidney transplant operation
Overall Study STARTED	1
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Eculizumab to Enable Renal Transplantation in Patients With History of Catastrophic Antiphospholipid Antibody Syndrome

Baseline characteristics by cohort

Measure	Eculizumab n=1 Participants Patients will receive eculizumab in conjunction with systemic anticoagulation before and after kidney transplant operation
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Outcome measures

Measure	Eculizumab n=1 Participants Patients will receive eculizumab in conjunction with systemic anticoagulation before and after kidney transplant operation
Number of Patients With Prevention of Catastrophic Antiphospholipid Antibody Syndrome (CAPS) After Kidney Transplant	1 Participants

SECONDARY outcome

Timeframe: 6 months

Outcome measures

Measure	Eculizumab n=1 Participants Patients will receive eculizumab in conjunction with systemic anticoagulation before and after kidney transplant operation
Number of Patients With Kidney Transplant Graft Survival	1 Participants

SECONDARY outcome

Timeframe: 6 months

Outcome measures

Measure	Eculizumab n=1 Participants Patients will receive eculizumab in conjunction with systemic anticoagulation before and after kidney transplant operation
Number of Patients Who Survive	1 Participants

Adverse Events

Eculizumab

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Eculizumab n=1 participants at risk Patients will receive eculizumab in conjunction with systemic anticoagulation before and after kidney transplant operation
Immune system disorders neutropenia	100.0% 1/1 • Number of events 1 • 6 months
Blood and lymphatic system disorders subtherapeutic INR	100.0% 1/1 • Number of events 1 • 6 months

Other adverse events

Adverse event data not reported

Additional Information

Benjamin Philosophe

Johns Hopkins University

Phone: 443-287-7178

Email: bphilosophe@jhmi.edu

Results disclosure agreements

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