Antibody Mediated Rejection of Kidney TransplantPhase 2NCT02936479
C1-Inhibitor (INH) for Refractory Antibody Mediated Renal Allograft Rejection
A Phase 2 study testing C1-INH (Berinert) in people with Antibody Mediated Rejection of Kidney Transplant, run by NYU Langone Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Antibody Mediated Rejection of Kidney Transplant
- What is being tested?
- C1-INH (Berinert)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2016to 30 Oct 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Kidney transplant with acute antibody mediated rejection refractory to standard therapy
Who cannot join
- Patients with known intolerance of or anaphylaxis to Berinert
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
Official title: Use of C1-INH (Berinert) for Renal Allograft Salvage in Refractory Antibody Mediated Rejection
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.
- Being tested
- C1-INH (Berinert)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C1-INH (Berinert)Drug
| Study group | Role | What they receive |
|---|---|---|
| Berinert treatment | Experimental | Not described Receives: Drug: C1-INH (Berinert) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2016 (estimated)
- Study startOct 2016
- Primary completion30 Oct 2018
- Study completion30 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Antibody Mediated Rejection of Kidney TransplantStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- CSL Behring
- Responsible party
- Sponsor
- Investigators
- Robert Montgomery, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02936479
- Sponsor's protocol ID
- 16-01851
- Status last verified
- Jul 2019
- First submitted
- 14 Oct 2016
- Last updated
- 11 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of C1-INH (Berinert) for Renal Allograft Salvage in Refractory Antibody Mediated Rejection
- ClinicalTrials.gov ID
- NCT02936479
- Acronym / sponsor ID
- 16-01851
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- CSL Behring
- Study start
- Oct 2016 (actual)
- Primary completion
- 30 Oct 2018 (actual)
- Study completion
- 30 Oct 2018 (actual)
- First posted
- 18 Oct 2016 (estimated)
- Results
- Posted 11 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Berinert treatment | Experimental | Drug: C1-INH (Berinert) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Kidney transplant with acute antibody mediated rejection refractory to standard therapy
Key exclusion criteria (1 listed)
- Patients with known intolerance of or anaphylaxis to Berinert
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| C1-INH (Berinert) | Drug | Berinert treatment |
Primary outcome
Renal Allograft Survival Measured by Severe and Refractory Antibody Mediated Renal (AMR)
Time frame: 24 months
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Montgomery, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing C1-INH (Berinert) in people with Antibody Mediated Rejection of Kidney Transplant, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Renal Allograft Survival Measured by Severe and Refractory Antibody Mediated Renal (AMR) (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2019.