Berinert for Kidney Transplant Outcomes

(IMPROVE Trial)

Recruiting at 3 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Must not be taking: Anticoagulants, Antiplatelets, Immunomodulators, others

Disqualifiers: Obesity, Malignancy, HIV, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Single administration

180 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does exclude those requiring chronic anti-coagulation or anti-platelet therapy, except for ASA and NSAIDs. It's best to discuss your specific medications with the study team.

How does the drug Berinert differ from other treatments for kidney transplant outcomes?

Berinert is unique because it is primarily used to treat hereditary angioedema (a condition causing severe swelling) by providing a protein called C1 esterase inhibitor, which is not typically used in kidney transplant treatments. This makes it different from standard immunosuppressive drugs that are commonly used to prevent organ rejection in kidney transplants. ^{1 2 3 4 5}

What is the purpose of this trial?

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)

Research Team

Peter S Heeger, MD

Principal Investigator

Cedars-Sinai Medical Center

Sindhu Chandran, MBBS, MD

Principal Investigator

Cedars-Sinai Medical Center

Stanley Jordan, MD

Principal Investigator

Cedars-Sinai Medical Center

Eligibility Criteria

This trial is for individuals receiving high-risk, deceased-donor kidney transplants. It aims to improve kidney function after the transplant. Specific eligibility criteria are not provided, but typically participants would need to meet certain health standards and not have conditions that could interfere with the study or their safety.

Inclusion Criteria

Vaccines up to date per Division of Allergy, Immunology, and Transplantation (DAIT) guidance for patients in transplant trials

Recipients of kidneys arriving to the transplant center on ex vivo hypothermic machine perfusion pumps are eligible

My blood clotting ability is normal.

Exclusion Criteria

I am not pregnant or breastfeeding.

I currently have an infection.

I am HIV positive.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single intragraft injection of C1 Esterase Inhibitor (Berinert) or placebo into the donor kidney prior to transplantation

Single administration

Follow-up

Participants are monitored for safety and effectiveness after transplantation, including renal function and incidence of thrombotic events

12 months

Regular visits for monitoring, including blood draws and biopsies

Long-term follow-up

Participants are monitored for long-term outcomes such as proteinuria and donor-specific antibodies

12 months

Treatment Details

Interventions

• Berinert

Trial Overview The IMPROVE TRIAL is testing whether a single injection of C1 Esterase Inhibitor (Berinert) into the donor kidney before transplantation can enhance kidney function in recipients compared to a placebo. The main measure of success is better kidney filtration rates at one year post-transplant.

Participant Groups

Group I: Berinert Experimental Treatment 1 Intervention

Group II: Saline Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

National Institute of Allergy and Infectious Diseases (NIAID)

Lead Sponsor

Trials

3,361

Recruited

5,516,000+

References

1. Australia pubmed.ncbi.nlm.nih.gov

Development and future deployment of a 5 years allograft survival model for kidney transplantation. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Treatment of chronic allograft nephropathy at late stages using everolimus or FTY720 in combination with cyclosporine. [2015]

3. Germany pubmed.ncbi.nlm.nih.gov

Efficacy and safety of everolimus plus low-dose calcineurin inhibitor vs. mycophenolate mofetil plus standard-dose calcineurin inhibitor in renal transplant recipients: A systematic review and meta-analysis . [2018]

4. Poland pubmed.ncbi.nlm.nih.gov

[Immunossupresive drugs in renal transplantation]. [2017]

5. United States pubmed.ncbi.nlm.nih.gov

Changes in renal transplantation: comparison between two different series. [2021]