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

What is the Purpose of this Study?

This study focuses on people who are waiting for a deceased donor kidney transplant and, as determined at the time of transplant, are receiving a donated kidney at risk of damage from having decreased oxygen levels. Risk factors for damage are thought to include factors that cannot be readily changed, such as donor qualities (age, birth sex, race, medical history), how much time it takes to get the donated kidney to the recipient’s hospital, and perhaps how it was transported (on ice or in a pumped machine). Researchers want to understand how it happens and how to protect against it. This study hopes to determine whether a drug called berinert, when injected into the transplanted kidney right before the operation, can interrupt the damage process and improve kidney function in the first year after transplant. Researchers also want to determine the effects that berinert will have in the kidney recipient. 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 with placebo (inactive substance). The dose of berinert or placebo will be recorded, and participants will be monitored for side effects. Blood, kidney tissue, and urine will be collected for research tests. The use of berinert in this study is considered experimental.


Eligibility

  • 1. Participant must be able to understand and provide informed consent
  • 2. Adults who are on chronic dialysis therapy and are on the wait list for deceased donor kidney transplant
  • 3. Recipients who are ABO compatible with donor allograft
  • 4. Negative crossmatch and no donor specific anti-HLA antibody (DSA) on most recent pretransplant serum sample as determined by local site
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Where can I participate?

Beverly

More about this Clinical Trial

What is the full name of this clinical trial?

IMPROVING DECEASED-DONOR KIDNEY TRANSPLANT OUTCOMES VIA A SINGLE INTRAGRAFT INJECTION OF C1 ESTERASE INHIBITOR

Study Details
Disease Type/Condition

Other

Principal Investigator

Jordan, Stanley

Age Group

Adult

Phase

N/A

IRB Number

STUDY00003979

ClinicalTrials.gov ID

NCT06919003

Key Eligibility
ClinicalTrials.gov

How do I learn more about this study?
Email
clinicaltrials@cshs.org
Study Detail
Disease Type/Condition

Other

Principal Investigator

Jordan, Stanley

Age Group

Adult

Phase

N/A

IRB Number

RTB-021

ClinicalTrials.gov ID

NCT06919003

Key Eligibility
ClinicalTrials.gov

Contact
Email
clinicaltrials@cshs.org