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Spleen Transplant for Kidney Transplant Rejection

N/A
Waitlist Available
Led By Ivo Tzvetanov, MD
Research Sponsored by University of Illinois at Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subject is ≥ 18 years of age
Subject is eligible for a kidney or simulateous kidney pancreas transplant
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights

Study Summary

This trial is testing a new way to transplant kidneys in people who are highly sensitized, in the hopes that it will decrease the risk of early acute antibody mediated rejection.

Who is the study for?
This trial is for adults over 18 who need a kidney or kidney-pancreas transplant and are highly sensitized with anti-HLA antibodies (cPRA 98-100%). They must have a positive T flow crossmatch, agree to the study's terms in writing, and not be pregnant nor plan pregnancy within a year. Excluded are those with severe heart issues, less than a year life expectancy, recent serious infections, substance abuse problems, or uncontrolled psychiatric conditions.Check my eligibility
What is being tested?
The trial is testing spleen transplantation as an intervention for patients facing organ rejection after receiving a kidney or pancreas transplant. It aims to address challenges faced by patients with high levels of preformed anti-HLA antibodies that increase the risk of acute antibody-mediated rejection.See study design
What are the potential side effects?
While specific side effects aren't listed here, spleen transplantation can generally lead to increased infection risks due to its role in immune function. There may also be surgical risks such as bleeding or blood clots associated with the procedure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I am eligible for a kidney or kidney-pancreas transplant.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Rate of graft success
Rate of patient survival
Rate of successful spleen transplantations/removals that can overcome the immunological barrier of positive T flow crossmatch and allow better results in kidney transplant recipients with high cPRA compared to the standard treatment.
Secondary outcome measures
Rate of T flow crossmatch that becomes negative

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: highly sensitized patients with either a positive FCXM, or positive CDC cross-matchExperimental Treatment1 Intervention
highly sensitized patients that receive a donor offer and have either a positive FCXM (T or B cell positive) or positive CDC cross-match (B cell positive); a positive CDC cross-match (T cell positive) remains a contraindication at this time.
Group II: historical cohort of highly sensitized patients with a positive FCXM, or positive CDC cross-matchActive Control1 Intervention
The control group, as comparison, will be an historical cohort of highly sensitized patients with positive flow (B and T) or positive B standard crossmatch, which received kidney transplant alone or simultaneous kidney and pancreas transplant and followed our standard protocol

Find a Location

Who is running the clinical trial?

University of Illinois at ChicagoLead Sponsor
607 Previous Clinical Trials
1,559,355 Total Patients Enrolled
Ivo Tzvetanov, MDPrincipal InvestigatorUniversity of Illinois at Chicago

Media Library

Spleen Transplantation/Removal Clinical Trial Eligibility Overview. Trial Name: NCT04827186 — N/A
B Cell Alloimmunization Research Study Groups: historical cohort of highly sensitized patients with a positive FCXM, or positive CDC cross-match, highly sensitized patients with either a positive FCXM, or positive CDC cross-match
B Cell Alloimmunization Clinical Trial 2023: Spleen Transplantation/Removal Highlights & Side Effects. Trial Name: NCT04827186 — N/A
Spleen Transplantation/Removal 2023 Treatment Timeline for Medical Study. Trial Name: NCT04827186 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current enrollment size of this experiment?

"Affirmative. Records published on clinicaltrials.gov demonstrate that this research endeavour, which first went live on March 26th 2021, is actively recruiting volunteers. 40 participants are required at one medical facility to complete the trial."

Answered by AI

Is recruitment for this trial still ongoing?

"This medical trial, which was initially publicized on March 26th 2021 and subsequently revised on the 30th of the same month, is presently recruiting participants."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Spleen Transplant in Solid Organ Transplantation
Ivo G Tzvetanov 2021. "Spleen Transplant in Solid Organ Transplantation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04827186.
~0 spots leftby Apr 2025
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