## Protocol Section
### Identification Module
**NCT ID:** NCT02936479

**Brief Title:** C1-Inhibitor (INH) for Refractory Antibody Mediated Renal Allograft Rejection

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

#### Organization Study ID Info
**ID:** 16-01851
#### Organization
**Class:** OTHER
**Full Name:** NYU Langone Health
### Status Module
#### Completion Date
**Date:** 2018-10-30

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2019-07-11

**Type:** ACTUAL

**Last Update Submit Date:** 2019-07-10

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2018-10-30

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2019-07-11

**Type:** ACTUAL

**Results First Submit Date:** 2018-12-24

**Results First Submit QC Date:** 2019-07-10

#### Start Date
**Date:** 2016-10

**Type:** ACTUAL

**Status Verified Date:** 2019-07

#### Study First Post Date
**Date:** 2016-10-18
**Type:** ESTIMATED
**Study First Submit Date:** 2016-10-14
**Study First Submit QC Date:** 2016-10-14
### Sponsor Collaborators Module

#### Collaborators

**Class:** INDUSTRY

**Name:** CSL Behring

#### Lead Sponsor

**Class:** OTHER

**Name:** NYU Langone Health

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** True

**Is US Export:** True

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Antibody Mediated Rejection of Kidney Transplant

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 1

**Type:** ACTUAL

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Drug: C1-INH (Berinert)

**Label:** Berinert treatment

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Berinert treatment

**Name:** C1-INH (Berinert)

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** 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

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

**Time Frame:** 24 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

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

Exclusion Criteria:

* Patients with known intolerance of or anaphylaxis to Berinert

**Maximum Age:** 70 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** New York

**Country:** United States

**Facility:** New York University School of Medicine

**State:** New York

**Zip:** 10016

#### Overall Officials

**Official 1:**

**Affiliation:** NYU Langone Health

**Name:** Robert Montgomery, MD

**Role:** PRINCIPAL_INVESTIGATOR

## Document Section

### Large Document Module

#### Large Docs

- Date: 2016-10-28

- Filename: Prot_SAP_000.pdf

- Has ICF: False

- Has Protocol: True

- Has SAP: True

- Label: Study Protocol and Statistical Analysis Plan

- Size: 750513

- Type Abbrev: Prot_SAP

- Upload Date: 2018-12-20T14:36

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: BC16

- Name: Diseases and Abnormalities at or Before Birth

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: BC20

- Name: Immune System Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M27584

- Name: Angioedemas, Hereditary

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Ancestors

- ID: D000051056

- Term: Complement Inactivating Agents

- ID: D000007166

- Term: Immunosuppressive Agents

- ID: D000007155

- Term: Immunologic Factors

- ID: D000045505

- Term: Physiological Effects of Drugs

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M4225

- Name: Antibodies

- Relevance: LOW

- As Found: Unknown

- ID: M10184

- Name: Immunoglobulins

- Relevance: LOW

- As Found: Unknown

- ID: M26365

- Name: Complement C1 Inhibitor Protein

- Relevance: HIGH

- As Found: Reboxetine

- ID: M6392

- Name: Complement System Proteins

- Relevance: LOW

- As Found: Unknown

- ID: M6401

- Name: Complement C1 Inactivator Proteins

- Relevance: HIGH

- As Found: Reboxetine

- ID: M10212

- Name: Immunosuppressive Agents

- Relevance: LOW

- As Found: Unknown

- ID: M10201

- Name: Immunologic Factors

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000003174

- Term: Complement C1 Inactivator Proteins

- ID: D000050718

- Term: Complement C1 Inhibitor Protein

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** Berinert Treatment

**Deaths Num At Risk:** 1

**Description:** C1-INH (Berinert)

**ID:** EG000

**Other Num Affected:** 1

**Other Num at Risk:** 1

**Serious Number At Risk:** 1

**Title:** Berinert Treatment

**Frequency Threshold:** 0

#### Other Events

**Term:** skin infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Notes:** left posterior extremity skin infection

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** 

**Term:** urinary tract infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Notes:** klebsiella pneumoniae urinary tract infection

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** 

**Time Frame:** 17 months

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 1

**Units:** Participants

### Group

**ID:** BG000

**Title:** Berinert Treatment

**Description:** C1-INH (Berinert)

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 1

**Class Title:** 54 Years Old

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 1

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

**Category Title:** Hispanic or Latino

#### Measurement

**Group ID:** BG000

**Value:** 1

**Category Title:** Not Hispanic or Latino

#### Measurement

**Group ID:** BG000

**Value:** 0

**Category Title:** Unknown or Not Reported

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

**Category Title:** American Indian or Alaska Native

#### Measurement

**Group ID:** BG000

**Value:** 0

**Category Title:** Asian

#### Measurement

**Group ID:** BG000

**Value:** 0

**Category Title:** Native Hawaiian or Other Pacific Islander

#### Measurement

**Group ID:** BG000

**Value:** 1

**Category Title:** Black or African American

#### Measurement

**Group ID:** BG000

**Value:** 0

**Category Title:** White

#### Measurement

**Group ID:** BG000

**Value:** 0

**Category Title:** More than one race

#### Measurement

**Group ID:** BG000

**Value:** 0

**Category Title:** Unknown or Not Reported

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 1

**Class Title:** United States

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Age, Customized
**Unit of Measure:** Participants
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 3
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Ethnicity (NIH/OMB)
**Unit of Measure:** Participants
### Measure 4
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Race (NIH/OMB)
**Unit of Measure:** Participants
### Measure 5
**Parameter Type:** NUMBER
**Title:** Region of Enrollment
**Unit of Measure:** participants
## Results Section - More Information Module
### Certain Agreement
**PI Sponsor Employee:** True
### Point of Contact
**Email:** Cecilia.Deterville@nyulangone.org
**Organization:** NYU Langone Health- Transplant Institute
**Phone:** 212.263.3620
**Title:** Cecilia Deterville, MS, CCRC
## Results Section - Outcome Measures Module
### Outcome Measure 1
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** 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
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Reporting Status:** POSTED
**Time Frame:** 24 months
**Title:** Renal Allograft Survival Measured by Severe and Refractory Antibody Mediated Renal (AMR)
**Type:** PRIMARY
**Unit of Measure:** Participants
##### Group
**Description:** C1-INH (Berinert)
**ID:** OG000
**Title:** Berinert Treatment
### Participant Flow Module
#### Group
**Description:** C1-Inhibitor (INH) (Berinert): C1 esterase inhibitor, Berinert, 25-50 units/kg, intravenous, 7 doses on days 1, 3, 5, 7, 9, 11, 13 and 50 units/kg twice weekly for a total study period of 6 months.
**ID:** FG000
**Title:** Berinert Treatment
#### Period
**Title:** Overall Study
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 1
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 1
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
**Has Results:** True