NCT02936479

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Oct 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

October 14, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 18, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2018

Completed
8 months until next milestone

Results Posted

Study results publicly available

July 11, 2019

Completed
Last Updated

July 11, 2019

Status Verified

July 1, 2019

Enrollment Period

2.1 years

First QC Date

October 14, 2016

Results QC Date

December 24, 2018

Last Update Submit

July 10, 2019

Conditions

Antibody Mediated Rejection of Kidney Transplant

Outcome Measures

Primary Outcomes (1)

  • 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

    24 months

Study Arms (1)

Berinert treatment

EXPERIMENTAL
Drug: C1-INH (Berinert)

Interventions

C1-INH (Berinert)DRUG
Berinert treatment

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Patients with known intolerance of or anaphylaxis to Berinert

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Interventions

Complement C1 Inhibitor Protein

Intervention Hierarchy (Ancestors)

GlycoproteinsGlycoconjugatesCarbohydratesComplement C1 Inactivator ProteinsSerpinsPeptidesAmino Acids, Peptides, and ProteinsComplement Inactivator ProteinsComplement System ProteinsImmunoproteinsBlood ProteinsProteins

Results Point of Contact

Title
Cecilia Deterville, MS, CCRC
Organization
NYU Langone Health- Transplant Institute
Cecilia.Deterville@nyulangone.org
212.263.3620

Study Officials

  • Robert Montgomery, MD

    NYU Langone Health

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 14, 2016

First Posted

October 18, 2016

Study Start

October 1, 2016

Primary Completion

October 30, 2018

Study Completion

October 30, 2018

Last Updated

July 11, 2019

Results First Posted

July 11, 2019

Record last verified: 2019-07

Locations

US(1)