FindTrial
Sign In

C1-Inhibitor (INH) for Refractory Antibody Mediated Renal Allograft Rejection

Use of C1-INH (Berinert) for Renal Allograft Salvage in Refractory Antibody Mediated Rejection

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02936479
Enrollment
1
Registered
2016-10-18
Start date
2016-10-31
Completion date
2018-10-30
Last updated
2019-07-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Antibody Mediated Rejection of Kidney Transplant

Brief summary

This is an open-label, single arm trial in which patient who have ongoing antibody mediated rejection of a kidney transplant deemed refractory to maximal medical therapy are given the complement inhibitor C1-INH (Berinert) in an effort to protect the graft from ongoing antibody mediated injury. A maximum of 5 patients will be enrolled.

Interventions

DRUGC1-INH (Berinert)

Sponsors

CSL Behring
CollaboratorINDUSTRY
NYU Langone Health
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* Kidney transplant with acute antibody mediated rejection refractory to standard therapy

Exclusion criteria

* Patients with known intolerance of or anaphylaxis to Berinert

Design outcomes

Primary

MeasureTime frameDescription
Renal Allograft Survival Measured by Severe and Refractory Antibody Mediated Renal (AMR)24 monthsnumber of patients that presented with severe and refractory Antibody Mediated Renal (AMR) following kidney transplant and survived beyond one year after study drug administration

Countries

United States

Participant flow

Participants by arm

ArmCount
Berinert Treatment
C1-INH (Berinert)
1
Total1

Baseline characteristics

CharacteristicBerinert Treatment
Age, Customized
54 Years Old
1 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
1 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
1 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
White
0 Participants
Region of Enrollment
United States
1 participants
Sex: Female, Male
Female
0 Participants
Sex: Female, Male
Male
1 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 1
other
Total, other adverse events
1 / 1
serious
Total, serious adverse events
0 / 1

Outcome results

Primary

Renal Allograft Survival Measured by Severe and Refractory Antibody Mediated Renal (AMR)

number of patients that presented with severe and refractory Antibody Mediated Renal (AMR) following kidney transplant and survived beyond one year after study drug administration

Time frame: 24 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Berinert TreatmentRenal Allograft Survival Measured by Severe and Refractory Antibody Mediated Renal (AMR)1 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026