Bone marrow aspiration for Highly Sensitized Prospective Kidney Transplant Recipients

Phase-Based Estimates
1
Effectiveness
1
Safety
University of California at San Francisco Medical Center, San Francisco, CA
Bone marrow aspiration - Procedure
Eligibility
18+
All Sexes
Eligible conditions
Highly Sensitized Prospective Kidney Transplant Recipients

Study Summary

This study is evaluating whether two drugs may help make it easier to find a kidney donor for kidney transplant candidates.

See full description

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Bone marrow aspiration will improve 2 primary outcomes and 11 secondary outcomes in patients with Highly Sensitized Prospective Kidney Transplant Recipients. Measurement will happen over the course of Baseline (Visit 0) up to 26 weeks post treatment initiation.

Week 26
Proportion of subjects who meet any one of the pre-specified events detailed in the outcome description: from Baseline up to Week 26
Week 26
Proportion of subjects who have not met a subject stopping rule and remain free of all of the safety events listed in the outcome description, through 26 weeks after starting treatment or until receiving a transplant, whichever occurs earlier
Week 16
Incidence of cytomegalovirus (CMV) disease within 16 weeks after starting treatment
Incidence of invasive fungal infections, mycobacterial infections or Pneumocystis jirovecii infection within 16 weeks after starting treatment
Week 26
Incidence of cytomegalovirus (CMV) disease within 26 weeks after starting treatment
Incidence of invasive fungal infections, mycobacterial infections or Pneumocystis jirovecii infection within 26 weeks after starting treatment
Week 52
Incidence of cytomegalovirus (CMV) disease within 52 weeks after starting treatment
Incidence of cytomegalovirus (CMV) infection within 52 weeks after starting treatment
Incidence of invasive fungal infections, mycobacterial infections or Pneumocystis jirovecii infection within 52 weeks after starting treatment
Proportion of subjects transplanted with a previously incompatible donor within 52 weeks after starting treatment
Within 52 weeks post-transplant
Incidence of post-transplant lymphoproliferative disorder (PTLD)
Number of biopsy-proven acute or chronic AMR events within 52 weeks post-transplant in subjects who undergo a kidney transplant
Proportion of subjects with biopsy-proven acute or chronic antibody mediated rejection (AMR) within 52 weeks post-transplant in subjects who undergo a kidney transplant

Trial Safety

Trial Design

2 Treatment Groups

No Control Group
Cohort 1 (N=5 Subjects)

This trial requires 15 total participants across 2 different treatment groups

This trial involves 2 different treatments. Bone Marrow Aspiration is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.

Cohort 1 (N=5 Subjects)Multiple intravenous infusions of daratumumab and belatacept over 10 weeks: Daratumumab will be administered intravenously at a dose of 8 mg/kg weekly for 4 weeks, then every other week for 4 weeks (week 9 and week 11). The dose administered will be calculated based on the actual body weight of the subject at each visit. Belatacept will be administered intravenously at a dose of 10 mg/kg every 2 weeks starting at week 8 (dosed at weeks 8, 10, 12, and 14). The total infusion dose of belatacept will be based on the actual body weight of the subject at the baseline visit, and will not be modified during the course of therapy, unless there is a change in body weight of greater than 10%.
Cohort 2 (N=10 Subjects)The enrollment of ten additional subjects is dependent on the results in Cohort 1. Multiple intravenous infusions of daratumumab and belatacept over 10 weeks:° Daratumumab will be administered intravenously at a dose of 8 mg/kg weekly for 4 weeks, then every other week for 4 weeks (week 9 and week 11). The dose administered will be calculated based on the actual body weight of the subject at each visit. Belatacept will be administered intravenously at a dose of 10 mg/kg every 2 weeks starting at week 8 (dosed at weeks 8, 10, 12, and 14). The total infusion dose of belatacept will be based on the actual body weight of the subject at the baseline visit, and will not be modified during the course of therapy, unless there is a change in body weight of greater than 10%. May be modified based on the safety and efficacy analysis of Cohort 1.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Daratumumab
FDA approved
Belatacept
FDA approved
Bone marrow aspiration
2000
Completed Phase 2
~260

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: within 16 weeks post treatment initiation
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly within 16 weeks post treatment initiation for reporting.

Closest Location

University of California at San Francisco Medical Center - San Francisco, CA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
People with a cPRA of greater than 98 percent who have an HLA-incompatible approved living donor and haven't received a transplant after one year in a paired kidney exchange program are also eligible. show original
The most recent tuberculosis (TB) testing results were negative, or the appropriate latent TB infection (LTBI) therapy was completed. show original
People who test positive for LTBI must complete appropriate therapy for LTBI show original
ations are as follows: Here are the names of people who are waiting for a deceased donor transplant and have a calculated panel reactive antibody (cPRA) of 99. show original
They must be human They must be of legal age They must be in generally good health They must be able to comply with the study protocol Any human who meets the age, health, and compliance criteria is eligible for a study, regardless of race or gender. show original
The person making the decision must be able to understand what is happening and give consent that they are happy for the procedure to go ahead. show original
End stage renal disease (ESRD) on hemodialysis
The text states that there is evidence of immunity to Epstein-Barr Virus (EBV) as demonstrated by serologic testing show original
Testing should be conducted using either a PPD or interferon-gamma release assay (i.e., QuantiFERON-TB, T-SPOT.TB)
The following text states that results from any tests performed within 12 months prior to study entry are acceptable, so long as the individual has not been exposed to tuberculosis in the meantime. show original

Patient Q&A Section

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

How many people get highly sensitized prospective kidney transplant recipients a year in the United States?

Add answer

Over 50% of all kidneys in the US are incompatible, with high levels of donor specific immunoglobulin M. A program based on DSA screening and early intervention as a strategy to prevent allograft rejection, in conjunction with immunosuppressive medications, is recommended to minimize allograft loss and optimize patient survival.

Unverified Answer

Can highly sensitized prospective kidney transplant recipients be cured?

Add answer

In a recent study, findings emphasizes the importance of immunosuppression for prevention of early rejection after kidney transplantation and is compatible with the hypothesis that high level of antibodies can be a cause for early rejection. In addition to our study there exist a number of studies that support the hypothesis that tacrolimus-based immunosuppressive therapy is associated with less rejection. Although our study needs to be extended with a larger number of recipients and a larger patient population, we think that treatment with tacrolimus or sirolimus might prevent early rejection in highly sensitized kidney transplant patients.

Unverified Answer

What is highly sensitized prospective kidney transplant recipients?

Add answer

All patients who are highly sensitized may still benefit from [kidney transplant](https://www.withpower.com/clinical-trials/kidney-transplant)ation, but they have a higher complication rate and longer hospital stays. Nevertheless, with careful and precise management, they can enjoy an improved quality and a longer graft survival.

Unverified Answer

What are the signs of highly sensitized prospective kidney transplant recipients?

Add answer

Specific signs of HSP-N KTX may be different for each individual patient. Some signs of HSP-N KTX were common among this group of patients and included skin itchiness, diarrhea and question: Does erythropoietin therapy decrease the need for dialysis in patients with chronic renal insufficiency? answer: Use of Epo is associated with an improvement in glomerular filtration rate in patients with CKD.

Unverified Answer

What are common treatments for highly sensitized prospective kidney transplant recipients?

Add answer

The use of ATG is very effective in preventing graft rejection and the immunosuppressive dose can be lowered by the use of mycophenolate mofetil. However, the most common treatment option is the use of tacrolimus.

Unverified Answer

What causes highly sensitized prospective kidney transplant recipients?

Add answer

In highly sensitized patients, the immunosuppressive treatment must be individualized; furthermore, an active strategy for the prevention of rejections and a selective treatment tailored to each individual are needed, as well as a strategy for guiding the discontinuation of the IS.

Unverified Answer

What is the latest research for highly sensitized prospective kidney transplant recipients?

Add answer

There is a growing amount of evidence suggesting IgG-Ab-mediated rejection of the transplanted kidney. The current understanding is that this is mediated by IgM-anti-FcgammaRIII antibodies which react to allo-HPAg-FcgammaR-III receptors on the surface of the podocytes.

Unverified Answer

Does highly sensitized prospective kidney transplant recipients run in families?

Add answer

The finding that half of the families were of two or more generations points to a genetic factor. As only a minority of these children had either previous or future antibody problems, it can be speculated that other genes or genes outside the HBB locus influence the development of HLA antibodies.

Unverified Answer

Does bone marrow aspiration improve quality of life for those with highly sensitized prospective kidney transplant recipients?

Add answer

Based on these results and in contrast to the conclusions of one published study, our study provides no evidence that bone marrow aspiration improves quality of life for highly sensitized potential kidney transplant recipients while in the hospital for the dialysis phase of the maintenance treatment of the highly sensitized recipient.

Unverified Answer

What is the primary cause of highly sensitized prospective kidney transplant recipients?

Add answer

The primary causes of HS PKTR were the following: antibody-mediated rejection, drug intolerance and rejection-related causes of HS. We suggest that there is no cause of HS PKTR.

Unverified Answer

Is bone marrow aspiration safe for people?

Add answer

The number of bone marrow biopsies in patients with no previous history of a febrile reaction (defined as a temperature > or = 102 F) is similar to that reported for those without history of fes. These data support performing a BM biopsy in all patients without history of fes.

Unverified Answer

Who should consider clinical trials for highly sensitized prospective kidney transplant recipients?

Add answer

Clinical trials can be a viable treatment option for highly sensitized potential kidney transplant recipients. Patients and their physicians can make informed decisions about the advantages and limits of clinical trials.

Unverified Answer
See if you qualify for this trial
Get access to this novel treatment for Highly Sensitized Prospective Kidney Transplant Recipients by sharing your contact details with the study coordinator.