Berinert for Kidney Transplant Outcomes

(IMPROVE Trial)

Recruiting at 5 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether Berinert, a medication, can improve kidney function after a transplant. Participants will receive either Berinert or a placebo, a harmless substance resembling the real treatment. The study targets individuals on long-term dialysis awaiting a deceased donor kidney transplant. It aims to determine if Berinert can enhance kidney function within the first year post-transplant. Ideal participants are those on the kidney transplant waiting list who have been undergoing dialysis treatment. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of people.

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.

Is there any evidence suggesting that Berinert is likely to be safe for humans?

Research has shown that Berinert, a C1 esterase inhibitor, is generally safe for transplant patients. Studies have not identified any specific toxicity or serious side effects directly linked to Berinert. Thus far, Berinert appears well-tolerated in transplant settings. As this trial is in an early phase, it primarily focuses on assessing the treatment's safety and ensuring it does not cause harmful effects. However, evidence from previous research suggests that Berinert is unlikely to cause serious problems for patients who receive it. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Berinert is unique because it targets a specific part of the immune response involved in inflammation, which could be beneficial for kidney transplant outcomes. Unlike current treatments that primarily aim to suppress the immune system broadly, Berinert focuses on inhibiting a protein called C1-esterase inhibitor. This targeted approach could potentially reduce the risk of transplant rejection with fewer side effects, making it an exciting prospect for improving long-term transplant success.

What evidence suggests that Berinert might be an effective treatment for kidney transplant outcomes?

Research suggests that Berinert, a protein that can help reduce inflammation and immune response, might improve kidney function after a transplant. In this trial, some participants will receive Berinert to study its potential to reduce problems with the new kidney, such as delayed function or injury. Although specific data for transplant patients remains limited, studies have not found any unique side effects from Berinert in this context. The treatment aims to boost kidney function, measured by the estimated glomerular filtration rate (eGFR), an important indicator of kidney health. This ongoing research seeks to confirm these early results and understand how Berinert might benefit transplant recipients. ^{1 2 4 5 6}

Who Is on the 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

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.cedars-sinai.edu clinicaltrials.cedars-sinai.edu/view/RTB-021

Improving Deceased-Donor Kidney Transplant Outcomes Via ... All participants will have a 50% chance of receiving a kidney that has been injected with berinert and a 50% chance of receiving a kidney that has been injected ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1600613522098070

A phase I/II, double-blind, placebo-controlled study ... Data recently reported by Taber et al analyzed the impact of the new kidney allocation system (KAS) on perioperative outcomes and cost in kidney transplantation ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04696146

NCT04696146 | Berinert (C1INH) vs Placebo for DGF/IRI This is a Phase I/II double-blind, randomized, placebo-controlled study assessing safety and limited efficacy of intraoperative C1INH (500U/kidney) vs.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7264819/

Potential Roles for C1 Inhibitor in Transplantation - PMC Although data in transplant patients are limited, no unique adverse effects attributable to C1-INH have emerged. Because C1-INH does not affect the alternative ...

5. trial.medpath.com trial.medpath.com/clinical-trial/4e9058ca4d674877/nct06919003-kidney-transplant-c1-esterase-inhibitor

Improving Deceased-Donor Kidney Transplant Outcomes Via ... 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, ...

6. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/14/NCT02134314/Prot_SAP_000.pdf

C1INH (Berinert®) IRI Study in Kidney Transplant Since this study is a Phase I/II, we will primarily explore the safety of the proposed dose in the renal transplant population receiving high-risk ECD and ...