Delayed Graft FunctionPhase 3NCT02474667
Reduce the Severity of DGF in Recipients of a Deceased Donor Kidney
A Phase 3 study testing ANG-3777 in people with Delayed Graft Function, run by Angion Biomedica Corp at 30 sites in United States.
Trial summary
The major objective is to demonstrate the safety and efficacy of ANG-3777 in improving graft function and reducing the severity of delayed graft function (DGF) in recipients at high risk of DGF after receiving a deceased donor renal allograft. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Delayed Graft Function
- What is being tested?
- ANG-3777
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 253 participants
- Where
- 30 sitesUnited States
- Study dates
- Mar 2016to Sep 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients must provide written informed consent using an Institutional Review Board/Independent Ethics Committee (IRB/IEC) approved consent form, and must understand and be willing and able to comply with the requirements of the study, including screening procedures and all required study visits.
- Males and females ≥ 18 years of age.
- Renal failure requiring hemodialysis or peritoneal dialysis initiated at least 3 months prior to transplantation.
- Patient is to be the recipient of a first kidney transplant from a deceased donor.
- Study drug can be administered starting within 30 hours after restoration of blood flow to the engrafted kidney.
- Body mass index < 40 based on dry weight. Dry weight and height parameters obtained within 7 days prior to study entry may be used..
- Estimated donor organ cold ischemia time less than 30 hours (for PMP kidneys less than 40 hours).
Who cannot join
- Scheduled for multiple organ transplantation or prior recipient of a transplanted organ.
- Recipient of an ABO-incompatible kidney.
- Recipient of pediatric en-bloc kidney transplantation or adult or pediatric planned transplant of dual kidneys (from the same donor) not transplanted en bloc.
- Recipient of a kidney preserved by normothermic pulsatile machine perfusion.
- Has measurable donor-specific antibody or positive cross-match requiring desensitization prior to transplantation or deviation from standard immunosuppressive therapy.
- Currently participating in or has participated in an investigational drug or medical device study within 30 days or five drug half-lives, whichever is longer, prior to enrollment into this study. Patients cannot be given another investigational agent during the course of this study (through Day 360). Patients may participate in another concurrent study only if that study is a non-interventional, observational investigation.
- Concurrent sepsis or active bacterial infection.
- Has an active malignancy or history within 5 years prior to enrollment in the study, of solid, metastatic or hematologic malignancy with the exception of basal or squamous cell carcinoma in situ of the skin that has been adequately treated.
Trial locations and contacts
30 sites in 1 country.
30 sites in 1 country
United States30 sites
University of Michigan Medical Center
Ann Arbor, Michigan, 48109
University of Colorado Hospital Anschuts Medical Campus
Aurora, Colorado, 80045
University of Maryland Medical Center
Baltimore, Maryland, 21201
University of Virginia
Charlottesville, Virginia, 22904
Rush University
Chicago, Illinois, 60612
University of Cincinnati
Cincinnati, Ohio, 45221
Ohio State University Medical Center
Columbus, Ohio, 43210
Northwestern University
Evanston, Illinois, 60208
Houston Methodist Hospital
Houston, Texas, 77030
Kansas University
Lawrence, Kansas, 66045
Keck Hospital of USC
Los Angeles, California, 90033
UCLA Medical Center
Los Angeles, California, 90095
University of Louisville
Louisville, Kentucky, 40292
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
University of Minnesota Medical Center
Minneapolis, Minnesota, 55454
Mount Sinai School of Medicine
New York, New York, 10029
Columbia University Medical Center
New York, New York, 10032
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Mayo Clinic Hospital in Arizona
Phoenix, Arizona, 85054
Virginia Commonwealth University (VCU) Medical Center of Virginia
Richmond, Virginia, 23298
UC Davis Medical Center
Sacramento, California, 95817
California Institute of Renal Research
San Diego, California, 92123
California Pacific Medical Center (Sutter)
San Francisco, California, 94115
University of California San Francisco Medical Center
San Francisco, California, 94143
University of Washinton Medical Center
Seattle, Washington, 98195
Barnes-Jewish Hospital
St Louis, Missouri, 63110
Tampa General Hospital
Tampa, Florida, 33606
Montefiore Medical Center BRANY
The Bronx, New York, 10467
Medstar Georgetown University Hospital
Washington D.C., District of Columbia, 20007
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157
About this study
Official title: A Multicenter, Prospective, Double-Blind, Randomized, Placebo-Controlled, Phase 3 Study of ANG-3777 (Formerly BB3) to Improve Graft Function and Reduce the Severity of Kidney Dysfunction or Delayed Graft Function Following Kidney Transplantation in Recipients of a Deceased Donor Kidney
The major objective is to demonstrate the safety and efficacy of ANG-3777 in improving graft function and reducing the severity of delayed graft function (DGF) in recipients at high risk of DGF after receiving a deceased donor renal allograft.
- Conditions
- Delayed Graft Function
- Being tested
- ANG-3777, Placebo
- Keywords
- DGF, Delayed Graft Function, Renal Transplantation, Deceased Donor Kidney, BB3, Kidney Transplantation, Acute Kidney Injury
- Medical subject headings
- Delayed Graft Function, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ANG-3777Drug
Also called Hepatocyte growth factor mimetic, BB3
PlaceboOther
Also called Normal saline
| Study group | Role | What they receive |
|---|---|---|
| BB3 | Active comparator | Administered IV for 30 min within 24 hours after transplantation and around 24 hours after previous dosing 3 days in a row Receives: Drug: ANG-3777 |
| Normal Saline | Placebo comparator | Administered IV for 30 min within 24 hours after transplantation and around 24 hours after previous dosing 3 days in a row Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The severity of DGF
The primary endpoint is renal function assessed by eGFR (using the CKD-EPI equation based on serum creatinine), with a primary analysis time point consisting of eGFR at month 12.
Measured: Day 360
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2015 (estimated)
- Study startMar 2016
- Primary completionSep 2021 (estimated)
- Study completionSep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delayed Graft FunctionStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 253 participants (actual)
Sponsor and investigators
- Lead sponsor
- Angion Biomedica Corp
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CTI Clinical Trial and Consulting Services
- Responsible party
- Sponsor
- Investigators
- John Neylan, MD, Study director, Angion Biomedica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02474667
- Sponsor's protocol ID
- 001-15
- Status last verified
- Apr 2021
- First submitted
- 12 Jun 2015
- Last updated
- 3 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective, Double-Blind, Randomized, Placebo-Controlled, Phase 3 Study of ANG-3777 (Formerly BB3) to Improve Graft Function and Reduce the Severity of Kidney Dysfunction or Delayed Graft Function Following Kidney Transplantation in Recipients of a Deceased Donor Kidney
- ClinicalTrials.gov ID
- NCT02474667
- Acronym / sponsor ID
- 001-15
- Conditions
- Delayed Graft Function
- Keywords
- DGF, Delayed Graft Function, Renal Transplantation, Deceased Donor Kidney, BB3, Kidney Transplantation, Acute Kidney Injury
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 253 participants (actual)
- Lead sponsor
- Angion Biomedica CorpIndustry (pharma, biotech, devices)
- Collaborators
- CTI Clinical Trial and Consulting Services
- Study start
- Mar 2016 (actual)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 18 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The major objective is to demonstrate the safety and efficacy of ANG-3777 in improving graft function and reducing the severity of delayed graft function (DGF) in recipients at high risk of DGF after receiving a deceased donor renal allograft.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BB3 | Active comparator | Drug: ANG-3777Administered IV for 30 min within 24 hours after transplantation and around 24 hours after previous dosing 3 days in a row |
| Normal Saline | Placebo comparator | Other: PlaceboAdministered IV for 30 min within 24 hours after transplantation and around 24 hours after previous dosing 3 days in a row |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- All patients must provide written informed consent using an Institutional Review Board/Independent Ethics Committee (IRB/IEC) approved consent form, and must understand and be willing and able to comply with the requirements of the study, including screening procedures and all required study visits.
- Males and females ≥ 18 years of age.
- Renal failure requiring hemodialysis or peritoneal dialysis initiated at least 3 months prior to transplantation.
- Patient is to be the recipient of a first kidney transplant from a deceased donor.
- Study drug can be administered starting within 30 hours after restoration of blood flow to the engrafted kidney.
Key exclusion criteria (8 listed)
- Scheduled for multiple organ transplantation or prior recipient of a transplanted organ.
- Recipient of an ABO-incompatible kidney.
- Recipient of pediatric en-bloc kidney transplantation or adult or pediatric planned transplant of dual kidneys (from the same donor) not transplanted en bloc.
- Recipient of a kidney preserved by normothermic pulsatile machine perfusion.
- Has measurable donor-specific antibody or positive cross-match requiring desensitization prior to transplantation or deviation from standard immunosuppressive therapy.
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 |
|---|---|---|
| ANG-3777Also: Hepatocyte growth factor mimetic, BB3 | Drug | BB3 |
| PlaceboAlso: Normal saline | Other | Normal Saline |
Primary outcome
The severity of DGF
Time frame: Day 360
The primary endpoint is renal function assessed by eGFR (using the CKD-EPI equation based on serum creatinine), with a primary analysis time point consisting of eGFR at month 12.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2021.
Related trials for Delayed Graft Function
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Bioimpedance and Multiparametric Ultrasound-Guided Fluid Management After Kidney Transplantation
Kidney Transplantation, Delayed Graft Function
Enrolling by invitation
Feasibility of Physical Prehabilitation for High-Risk Patients Undergoing Cardiac Surgery Via Sternotomy
Prehabilitation, Cardiac Surgery
Active, not recruitingPhase 2
ARGX-117 in Deceased Donor Kidney Transplant Recipients at Risk for Delayed Graft Function
Delayed Graft Function
Not yet recruiting
Drone Transport of Deceased-Donor Kidney Grafts Between Two French Hospitals Before Transplantation: a Pilot Safety Study
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The Impact of Intraoperative Diuretic Use on Delayed Graft Function Following Deceased Donor Renal Transplantation
Delayed Graft Function, Kidney Transplantation
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.
John Neylan, MD study director
Angion Biomedica
30 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ANG-3777 in people with Delayed Graft Function, run by Angion Biomedica Corp at 30 sites 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 7 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 3 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
The severity of DGF (time frame: Day 360). 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 3 Jun 2021.