IMPROVE Trial

What is the Purpose of this Study?

We will enroll 180 eligible adult recipients of first deceased donor kidney transplants into the study. Consent and enrollment will occur >48 hour prior to transplantation. This is a prospective double-blinded, randomized, placebo-controlled, multiple-center study of adult kidney transplant patients receiving a deceased donor kidney allograft considered high-risk for development of ischemia reperfusion injury. Recipients will be randomized (1:1) to receive donor kidneys treated with a single intrarenal injection of C1INH vs placebo on the back table in the operating room prior to transplantation. As rationalized in our power calculations we require 180 subjects (90 C1INH: 90 placebo) to have adequate power for detecting differences in the 1-year eGFR (primary endpoint) between treatment groups. We will follow subjects for 12 months post-transplant to assess the primary endpoint. We will continue limited follow up for all subjects for 3 years


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

STUDY00003979

ClinicalTrials.gov ID

NCT06919003

Key Eligibility
ClinicalTrials.gov

Contact
Email
clinicaltrials@cshs.org