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Kidney TransplantPhase 2IMPROVENCT06919003

Improving Deceased-Donor Kidney Transplant Outcomes Via a Single Intragraft Injection of C1 Esterase Inhibitor (IMPROVE TRIAL)

A Phase 2 study testing Berinert in people with Kidney Transplant, run by National Institute of Allergy and Infectious Diseases (NIAID) at 4 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The purpose of this study is to find out if Berinert can improve kidney function in the first year after transplant and to find out what effects, good or bad, Berinert will have in the kidney recipient. This research study will compare Berinert to placebo. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Kidney Transplant
What is being tested?
Berinert
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
180 participants
Where
4 sitesUnited States
Study dates
22 Sep 2025to 30 May 2032
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participant must be able to understand and provide informed consent
  • Adults who are on chronic dialysis therapy and are on the wait list for deceased donor kidney transplant
  • Recipients who are ABO compatible with donor allograft
  • Negative crossmatch and no donor specific anti-HLA antibody (DSA) on most recent pretransplant serum sample as determined by local site
  • Female participants of childbearing potential must have a negative pregnancy test upon study entry
  • All participants with reproductive potential must agree to use highly effective contraception for at least 12-moths post-transplant. Oral estrogen containing contraception must not be used during the first 3 months post-transplant
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  • Hepatitis C Virus Ab positive participants with negative Hepatitis C virus (HCV) Polymerase chain reaction (PCR) are eligible if they have spontaneously cleared infection or are in sustained virologic remission
  • Hepatitis C Virus negative recipients of a Hepatitis C Virus positive organ are eligible if they will be treated with the intent of inducing a sustained virologic remission
  • Recipients of kidneys arriving to the transplant center on ex vivo hypothermic machine perfusion pumps are eligible
  • Recipients of kidneys that received in situ normothermic regional perfusion in the donor are eligible. Kidneys that received normothermic machine perfusion after organ procurement (ex situ normothermic perfusion) are not eligible (See Exclusion #4)
  • Anticipated Cold Ischemia Time (CIT) >=12 hours
  • Kidney Donor Profile Index (KDPI) 21-95%. For KDPI 21-34% to be eligible, anticipated CIT must be >=24 hours
  • Patients with normal coagulation

Who cannot join

  • Inability or unwillingness of a participant to give written informed consent or comply with study protocol
  • Any prior or concurrent non-renal solid organ, or cellular transplant, or waitlisted for multi-organ transplant. Prior autologous transplant is allowed
  • Patients receiving enbloc kidneys
  • Kidneys that received ex vivo normothermic machine perfusion after procurement. Kidneys that received in situ normotherimic regional perfusion in the donor are eligible (see Inclusion #10)
  • Patients with a known pro-thrombotic disorder
  • Patients with a history of thrombosis or hyper-coagulable state, excluding dialysis access clotting or other superficial vein thrombosis not requiring long-term systemic treatment
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  • Body mass index (BMI) >=40 kg/m^2
  • Patients with a history of Hereditary Angioedema or use of C1 esterase inhibitor (C1INH) containing products or recombinant C1INH within 15 days prior to study entry
  • Patients with a known hypersensitivity to treatment with Berinert
  • Patients requiring chronic anti-coagulation or anti-platelet therapy. ASA and NSAIDS are allowed
  • Presence of active malignancy or history of malignancy less than 5 years in remission, excluding adequately treated in-situ cervical carcinoma, low grade prostate carcinoma, renal cell carcinoma stage T1N0M0 that has been treated with nephrectomy, or adequately treated basal or squamous cell carcinoma of the skin
  • Patients who are positive for Hep B infection (Hepatitis B surface antigen (HBsAg)+); patients with HbcAB+ are eligible if HBV PCR is negative
  • Any active infection
  • Human immunodeficiency virus (HIV) infection
  • Enrollment in another investigational trial
  • Recent recipient of any licensed or investigational live attenuated vaccine(s) within 4 weeks of enrollment
  • Current or planned use of immunomodulatory agents including but not limited to rituximab, belatacept, eculizumab, JAK inhibitors, anti-TNF agents
  • Female participants who are pregnant or lactating
  • Past or current medical problems, inclusive of mental health and substance abuse concerns, or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study
  • History of any stroke (including ischemic, hemorrhagic, or embolic) within the previous 6 months

Trial locations and contacts

4 sites in 1 country. Contact the study team or a site near you to ask about taking part.

United States4 sites, 4 recruiting

  • Northwestern Memorial Hospital

    Chicago, Illinois, 60611

    Laura Adams, 312-694-0242, laura.adams@nm.org

    Recruiting

  • Kansas University Medical Center

    Kansas City, Kansas, 66160

    Adam Schooey, 913-588-1699, aschooley@kumc.edu

    Recruiting

  • Cedars Sinai Medical Center

    Los Angeles, California, 90048

    Tillie Morrisette, 424-315-1316, tillie.morrisette@cshs.org

    Andrea Calderon, 310-423-2319, Andrea.Calderon@cshs.org

    Recruiting

  • Montefiore Medical Center

    The Bronx, New York, 10467-2401

    Harith Raees, 929-285-4339, hraees@montefiore.org

    Recruiting

Other trials in United States

About this study

Official title: Improving Deceased-Donor Kidney Transplant Outcomes Via a Single Intragraft Injection of C1 Esterase Inhibitor (RTB-021)

The purpose of this study is to find out if Berinert can improve kidney function in the first year after transplant and to find out what effects, good or bad, Berinert will have in the kidney recipient. This research study will compare Berinert to placebo. The placebo looks exactly like Berinert but does not contain any active drug. Placebos are used in research studies to see if the results are due to the study drug or due to other reasons. Neither you or the study doctor can choose or know which group is assigned.

The primary objective is to test whether intrarenal artery C1 esterase inhibitor (C1INH) injection into the donor kidney prior to transplantation improves kidney function in recipients of high risk, deceased donor kidney transplants as measured by 12-month Estimated Glomerular Filtration Rate (eGFR) Chronic Kidney Disease Epidemiology Collaboration (CDK-EPI)

Being tested
Berinert, Placebo for Berinert
Keywords
Kidney transplant, Deceased donor, Intragraft injection, C1 esterase inhibitor
Medical subject headings
Angioedemas, Hereditary

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BerinertBiological

    Also called C1 esterase inhibitor, C1INH

    Administered as a 10 ml renal artery infusion approximately 1-2 hours before implantation and reperfusion of the allograft

  • Placebo for BerinertOther

    Administered as a 10 ml renal artery infusion approximately 1-2 hours before implantation and reperfusion of the allograft

Study groups in NCT06919003
Study groupRoleWhat they receive
BerinertExperimentalNot described
Receives: Biological: Berinert
SalinePlacebo comparatorNot described
Receives: Other: Placebo for Berinert

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Difference between study arms in renal function

    Measured as Estimated Glomerular Filtration Rate Chronic Kidney Disease Epidemiology Collaboration (eGFRCKD-EPI) in ml/min/1.73m^2

    Measured: At 12-months post-transplantation

Secondary outcomes (12)

  1. Comparison between the treated and control group of the full iBox score

    The iBox scoring system is a composite biomarker panel. The full iBox scoring system consists of 4 elements all obtained 1-year post-transplant: a) eGFR (MDRD), b) DSA, c) urinary protein/creatine ratio, and d) histological abnormalities on a surveillance biopsy.

    Measured: At 12-months post-transplantation

  2. Incidence of biopsy proven acute rejection (BPAR)

    Measured: At 12-months post-transplantation

  3. Incidence of proteinuria

    Measured as spot urine protein/creatinine >1 g/g

    Measured: At 12-months post-transplantation

  4. Incidence of de novo donor specific anti-Human Leukocyte Antigen (HLA) antibody (DSA)

    Defined as the incidence of de novo DSA on standard of care or protocol directed blood draws up to and including the 12-month protocol blood draw.

    Measured: At 12-months post-transplantation

  5. Incidence of Grade 3 or higher infections

    Measured: At 12-months post-transplantation

  6. Incidence of Grade 3 or higher intraoperative or postoperative hemorrhage

    Measured: Within 4 weeks after transplantation

  7. Incidence of thrombotic or thromboembolic events

    Excluding superficial thrombophlebitis, catheter-related thrombosis and dialysis access thrombosis

    Measured: Within 4 weeks after transplantation

  8. Incidence of T cell mediated rejection (TCMR) that is steroid resistant

    Measured: At 12-months post-transplantation

  9. Incidence of TCMR that is BANFF grade 2 or higher

    Measured: At 12-months post-transplantation

  10. Incidence of antibody mediated rejection (ABMR)

    Measured: At 12-months post-transplantation

  11. Incidence of death

    Measured: At 12-months post-transplantation

  12. Incidence of Graft loss (including primary non function)

    Measured: At 12-months post-transplantation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Apr 2025
  2. Study start22 Sep 2025
  3. Primary completion30 May 2031 (estimated)
  4. Study completion30 May 2032 (estimated)

Resources

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
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
180 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06919003
Sponsor's protocol ID
DAIT RTB-021
Acronym
IMPROVE
Status last verified
Feb 2026
First submitted
2 Apr 2025
Last updated
27 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Berinert in people with Kidney Transplant, run by National Institute of Allergy and Infectious Diseases (NIAID) at 4 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 13 inclusion and 20 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: looking for participants now, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Difference between study arms in renal function (time frame: At 12-months post-transplantation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06919003.

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 27 Feb 2026.

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