belatacept for Renal Transplant Recipient Patients
This study is evaluating whether it is safe to give mesenchymal stromal cells to kidney transplant recipients, and the combination of the immunosuppressive (anti-rejection) study drugs plus the MSCs can allow a kidney transplant recipient to slowly reduce and/or then completely stop
See full descriptionAbout the trial for Renal Transplant Recipient Patients
Treatment Groups
This trial involves 3 different treatments. Belatacept is the primary treatment being studied. Participants will be divided into 3 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.
About The Treatment
Eligibility
This trial is for patients born any sex aged 18 and older. There are 9 eligibility criteria to participate in this trial as listed below.
Approximate Timelines
Measurement Requirements
This trial is evaluating whether belatacept will improve 1 primary outcome and 11 secondary outcomes in patients with Renal Transplant Recipient Patients. Measurement will happen over the course of 48 weeks from the time of last sirolimus dose.
Patient Q & A Section
What are common treatments for kidney transplantation?
There is no direct comparison with the best-of-many (BOOM) concept because of the unsuitability and complexity of these studies. The data that have been collected suggests that [kidney transplant](https://www.withpower.com/clinical-trials/kidney-transplant)ation has fewer problems than anticipated since it is a better way to treat end-stage kidney disease and that it helps prevent complications of chronic kidney failure from progressing to end-stage kidney disease.\n\nIt has been estimated that as many as one in every five people are affected with ADHD during their lifetime. The condition is more common amongst men. The prevalence of ADHD in children ranges from approximately 2% to 12% in the United States.\n\nThere are many treatments for ADHD.
What are the signs of kidney transplantation?
In summary, the main signs of transplantation, such as loss of graft function, occurrence of an acute rejection, a decrease in graft function due to chronic rejection or other immunologic diseases, are frequently seen. However, this is only a very general overview and for each individual the clinician must take into account the peculiar situation of the patient.
Can kidney transplantation be cured?
There is no cure for end-stage organ failure caused by all chronic conditions. However, [kidney transplant](https://www.withpower.com/clinical-trials/kidney-transplant)ation can be curative as transplanting only dysfunctional organs can extend patient and graft survival. In a recent study, findings of the aforementioned studies indicate that transplanted living kidney tissue is able to heal even after complete organ failure. In addition to kidney transplantation, heart and lung transplantation are curative and can extend life and health with appropriate transplantation protocols. [Organ replacement and transplantation for cure. - End-stage transplantation of organs, organs and life prolonging transplantation. - End-stage organ failure, organ transplantation, transplantation of organs, organ transplants, organ replacement, transplantation, heart_lung.
What is kidney transplantation?
The long-term benefits of [kidney transplant](https://www.withpower.com/clinical-trials/kidney-transplant)ation are not clear. There is concern that it may increase the risk of some diseases, including cancer of the lung, liver, and prostate. There is no conclusive evidence that transplantation carries an increased risk of dying early. There is no evidence that individuals who receive a kidney transplant are at a higher risk of developing end stage renal disease when compared to the general population. For most recipients kidney transplantation is probably the best option when options for treating end stage renal disease are limited.
What causes kidney transplantation?
Transplantation appears to be rare due to a combination of factors - the recipient is a relatively young patient on dialysis or a sibling with a renal disorder.
How many people get kidney transplantation a year in the United States?
5.3 percent of the population will require dialysis in 2050, due to an ageing population, high incidence of [kidney transplant](https://www.withpower.com/clinical-trials/kidney-transplant)-related complications (mainly cardiac graft failure), and a shortage of donor organs. The average life expectancy will be 6.5 years in 2050. Because of medical advances, the average survival time after kidney transplantation will not increase. In 2050, the number of patients on dialysis will be 924,000. The number of patients on the waiting list for a kidney transplant will be 35,000. For the future, the number of transplant centers, especially in-patient units, will be necessary.
Is belatacept typically used in combination with any other treatments?
The majority of subjects treated with belatacept reported some form of treatment with other treatments. The most common combinations included belatacept with: basiliximab (26%), rituximab (20%), tacrolimus (20%), ciclosporin (16%), cyclosporine (10%), and cyclophosphamide (10%). Subjects were generally willing to try these therapies and reported no significant adverse events with these combinations, although only a few were sufficiently long to determine an association with belatacept. Subjects tolerated some combination therapies better than others. For example, subjects taking belatacept and basiliximab had fewer adverse events than subjects taking belatacept and tacrolimus.
How does belatacept work?
Belatacept decreased the number of circulating B cells, as well as the overall B cell subsets in peripheral and lymphoid tissues and improved overall and disease-specific survival in the MERS-CoV mouse model of human coronavirus infection that causes Middle East respiratory syndrome/severe acute respiratory syndrome (MERS/SARS).
What is belatacept?
Belatacept is well tolerated in renal transplant patients treated with MMF/cyclosporine A with or without corticosteroids. An effect on renal function or a clinical benefit has not been demonstrated. A small percentage of patients discontinue belatacept due to adverse events. Data from a recent study are very reassuring. A randomized, controlled, prospective study with a similar design is planned to evaluate efficacy of belatacept in renal transplant patients treated with MMF/cyclosporine A. It will allow determination of the effect of belatacept on renal function over time. A 24-week trial would be sufficient.
What are the latest developments in belatacept for therapeutic use?
In early phase III clinical trials for ESRD, bOS 49-59 is no worse than c-MPR but superior to belatacept. A randomized, controlled phase III trial with a 3-year follow-up may determine whether bOS or c-MPR is the superior option for bOS.
Who should consider clinical trials for kidney transplantation?
Clinicians must determine who can receive [kidney transplant](https://www.withpower.com/clinical-trials/kidney-transplant)ation based on available guidelines and clinical knowledge. Trials designed to identify patient and treatment characteristics that increase transplantation are necessary, but there is no evidence that the clinical characteristics of patients with end stage kidney disease enable them to participate in these trials.
Does belatacept improve quality of life for those with kidney transplantation?
Improvement in QoL was sustained over 2 years. Belatacept treatment was not associated with improved QoL except for one subset of treatment patients who reported increased appetite.