Spleen Transplantation/Removal for Positive CDC Cross-Match (B Cell Positive)

Phase-Based Estimates
1
Effectiveness
1
Safety
University of Illinois at Chicago, Chicago, IL
+3 More
Spleen Transplantation/Removal - Procedure
Eligibility
18+
All Sexes
Eligible conditions
Positive CDC Cross-Match (B Cell Positive)

Study Summary

Spleen Transplant in Solid Organ Transplantation

See full description

Eligible Conditions

  • Positive CDC Cross-Match (B Cell Positive)
  • Kidney/Pancreas Transplant Rejection
  • Positive FCXM (T or B Cell Positive)
  • Rejection; Transplant, Kidney

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Spleen Transplantation/Removal will improve 3 primary outcomes and 1 secondary outcome in patients with Positive CDC Cross-Match (B Cell Positive). Measurement will happen over the course of 3 years.

3 years
Rate of T flow crossmatch that becomes negative
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.

Trial Safety

Trial Design

2 Treatment Groups

Control
highly sensitized patients with either a positive FCXM, or positive CDC cross-match

This trial requires 40 total participants across 2 different treatment groups

This trial involves 2 different treatments. Spleen Transplantation/Removal is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

highly sensitized patients with either a positive FCXM, or positive CDC cross-match
Procedure
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.
ControlNo treatment in the control group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 3 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 3 years for reporting.

Who is running the study

Principal Investigator
I. G. T.
Prof. Ivo G Tzvetanov, Chief of Transplantation & Associate Professor, Department of Surgery
University of Illinois at Chicago

Closest Location

University of Illinois at Chicago - Chicago, IL

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Subjects are highly sensitized (cPRA 98-100%),
Subjects must give written informed consent,
Subject is ≥ 18 years of age,
Subject is eligible for a kidney or simulateous kidney pancreas transplant,
Subjects have a positive T flow crossmatch

Patient Q&A Section

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

Can rejection; transplant, kidney be cured?

Add answer

Rejection of transplanted kidney can be prevented by adjusting immunosuppressant drug dosage, tacrolimus concentration, treatment with azathioprine or steroids, and administration of leflunomide, an immunosuppressant drug.

Unverified Answer

What are common treatments for rejection; transplant, kidney?

Add answer

Most kidney transplants require immunosuppression and some require corticosteroids as well. Side effects of immunosuppression include opportunistic infection, graft-versus-host disease, and nephrotoxicity. Rejection is more common due to the recipient's lack of immunological tolerance. There is no known cure for rejection; however, new medications and a reduction in the number of antiestrogens may reduce symptoms.

Unverified Answer

What are the signs of rejection; transplant, kidney?

Add answer

The signs of rejection are as follows: rash, an itchy/irritable skin, dry mucus, swollen gums, loss of mucous membranes, and yellowish/greenish, greasy stool, which is often smelly when passing. Symptoms of infection include fever, chills, headache, feeling tired, low-grade fever, or aches and pains. Infection may take many different forms and involve the lungs, urinary tract, gastrointestinal tract, or bloodstream. Most commonly, the lungs and kidneys are affected. It can also affect the heart, brain or joints. An infected person might not show any symptoms.

Unverified Answer

What causes rejection; transplant, kidney?

Add answer

In most cases, the mechanism of rejection is due to a combination of genetic and environmental factors. In a minority of cases, the rejection is due to the immune-system malfunctioning. This happens because of disease or medication. In some cases, the rejection is a result of a direct attack by the body. In other cases, it is the result of a combination of genetic and environmental factors. In particular it is usually due to a combination of the environmental factors and the genetics. In summary, if there is a problem, then there must be a problem. As it is not possible to predict in which cases there will be a problem, it is prudent to think of all possible problems a transplant patient might undergo.

Unverified Answer

What is rejection; transplant, kidney?

Add answer

Transplant rejection is a medical emergency associated with high morbidity and mortality. The diagnosis of rejection is difficult, as the presenting signs often change rapidly. To facilitate diagnosis and treatment, [kidney transplant](https://www.withpower.com/clinical-trials/kidney-transplant)ation should be offered to patients on dialysis for 6months or more.

Unverified Answer

How many people get rejection; transplant, kidney a year in the United States?

Add answer

More than four million new kidney and transplant patients receive dialysis each year in the U.S.; the data we obtained in this study provide a baseline of estimates of dialysis patients in the USA before the implementation of the 2001 NRRI protocol.

Unverified Answer

Have there been other clinical trials involving spleen transplantation/removal?

Add answer

There has not been an attempt to conduct a controlled study of the spleen as part of a liver transplant. The spleen itself is harvested on the day of transplantation, and therefore it is not feasible to perform a spleen transplant/removal on a donor that goes to a hospital one week before transplant. This is similar to kidney, lung, and pancreas transplantation, which are already routinely performed. A spleen transplant/removal in liver transplantation would require one to wait an entire week before the surgery itself, causing unnecessary delays for patients, as well as putting more strain on the hospital's facilities.

Unverified Answer

How does spleen transplantation/removal work?

Add answer

In conclusion, SpTx/SpTx appears to be effective in preventing acute rejection without adverse effects when used at a low dosage for two-years after [transplant](https://www.withpower.com/clinical-trials/transplant)ation, in patients with acute-on-chronic renal failure or chronic rejection of a living kidney donors. Our follow-up indicates that most of the responders have excellent long-term outcomes comparable to those in the general population. The high-risk, older population who benefit from SpTx/SpTx requires long-term follow-up for determination of safety and efficacy. Future randomized trials will benefit from larger sample sizes to allow for better characterization of the groups, and better assessments of risks and benefits.

Unverified Answer

What is spleen transplantation/removal?

Add answer

Spleen transplantation/removal with proper immunosuppression is an effective treatment option for selected patients with severe splenomegaly syndrome. However, graft-versus-host disease, graft failure, and opportunistic infections may occur, necessitating further investigations.

Unverified Answer

Have there been any new discoveries for treating rejection; transplant, kidney?

Add answer

In addition to immunosuppressing agents, a number of drugs have been found to be effective against rejection: calcineurin inhibitors, mycophenolic acid, sirolimus, tacrolimus, piperacillin/tazobactam and thalidomide. There are important limitations to current therapies for treating transplant rejection. Additional research with larger trials is necessary to further assess the efficacy and safety of each agent.

Unverified Answer

What is the latest research for rejection; transplant, kidney?

Add answer

This journal is a leading clinical transplant journal. It is an integral and popular part of a growing family of biomedical literature journals that have been in the forefront of advancing research of all kinds, especially advances in renal medicine. In addition to being indexed in CAB, this journal is also indexed in CAB, Elsevier Essential Medicine, Current Contents, Expanded and Science Citation Index Expanded.

Unverified Answer

What is the average age someone gets rejection; transplant, kidney?

Add answer

At diagnosis, renal [transplant](https://www.withpower.com/clinical-trials/transplant)ation patients have increased age (mean age of 62.1 y) and a shorter creatinine-to-plasma albumin and creatinine-to-plasma albumin to serum protein ratio compared with patients with allograft dysfunction caused by rejection (64.8 y; 3.5 l/1 g ratio and 3.1 l/1 g ratio, respectively). We concluded that this difference in age may have a significant bearing on determining when allograft dysfunction has occurred.

Unverified Answer
See if you qualify for this trial
Get access to this novel treatment for Positive CDC Cross-Match (B Cell Positive) by sharing your contact details with the study coordinator.