This trial is evaluating whether TCD601 will improve 1 primary outcome and 2 secondary outcomes in patients with Kidney Transplantation. Measurement will happen over the course of 24 months.
This trial requires 18 total participants across 3 different treatment groups
This trial involves 3 different treatments. TCD601 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 2 and have already been tested with other people.
The first indication of kidney transplantation is an increased creatinine level in the serum. Although an increase in creatinine is an indication of kidney failure, it could be associated with a number of other kidney diseases.
Almost 60,000 transplants were performed in 1997 but it is estimated that there will be more than 125,000 transplant patients and transplantation hospitals by 2012.
Given that chronic graft rejection is the leading cause of chronic kidney failure, transplant surgeons strive to avoid immunosuppression when possible. In addition, surgeons attempt to minimize the number of antirejection medications prescribed. The use of medications, especially antiretroviral regimens, can be limited when possible in patients who are treated with the immunosuppressive drugs. It is important to discuss all treatment options with all patients, especially those that have already begun steroids.
There are no factors that can predict risk of early rejection episodes in [kidney [transplant](https://www.withpower.com/clinical-trials/transplant)](https://www.withpower.com/clinical-trials/kidney-transplant) recipients. It is common practise to reduce immunosuppression to achieve higher graft survival, especially when immunosuppressive drug regimens have been shown to be associated with adverse renal outcomes. However, it has not been demonstrated that this is always the case, and this raises questions about patient selection and drug regimen. This is further complicated by the possibility of transplant recipient factors influencing the timing of rejection events even at this level. This issue is further complexed when one also considers the fact that many patients have factors associated with increased renal morbidity in their own disease trajectory. In particular, the patient's baseline renal status affects prognosis.
Based on the small amount of evidence available from trials of [kidney transplant](https://www.withpower.com/clinical-trials/kidney-transplant)ation, evidence to support the assumption that transplantation is never a curative treatment.
Currently available living related [kidney transplant](https://www.withpower.com/clinical-trials/kidney-transplant)ation is a better alternative than non-related allograft with equal incidence of rejection episodes. Furthermore, related living kidney transplantation is related lower post transplantion mortality when compared to non-related living kidney transplantation.
There were very few novel findings for treating [kidney [transplant](https://www.withpower.com/clinical-trials/transplant)](https://www.withpower.com/clinical-trials/kidney-transplant)ation. There was evidence that a reduction in posttransplant infection rates may be achieved through vaccination and that tacrolimus may be more effective when used to treat rejection than ciclosporin. However, the results of these studies should be viewed with some caution due to the inherent difficulty of studying an organ transplant, including: (1) the difficulty of controlling confounding factors that are common to all transplants including immunosuppressants used to regulate the immune system and the donor's immune status (pancreas, liver, kidney, heart, bone marrow); and (2) the difficulty of assessing outcomes long after transplantation.
The side effects of TCD601 were most commonly mild in nature and associated with the common side effects of immunosuppressant medication; no grade 3 side effects were reported. The most common dose adjustment required was to decrease the dose of TCD601. TCD601 had no clinically significant effect on liver or kidney function. TCD601 did not influence the blood chemistry tests used in the dosing assessments. Recent findings of this study have shown that even with the use of such a modestly increasing dose of TCD601, the rate of serious side effects was extremely low.
Most adults who suffer acute kidney failure due to chronic renal failure have less serious long-term outcomes after a [kidney [transplant](https://www.withpower.com/clinical-trials/transplant)](https://www.withpower.com/clinical-trials/kidney-transplant)ation than they would expect, as long as they maintain good blood-sugar control and take their antirejection medications regularly. The long-term survival rate for those in end-stage acute kidney failure after two years following transplantation is 90% or 80% in the study population. A patient who has experienced a kidney transplant may be encouraged to consider joining the active kidney-donor registry if the patient desires. This can improve their chances of receiving a suitable kidney to replace their ailing one.
In a recent study, findings suggests familial occurrence of ESRD in the general population because of the high frequency of familial renal disease. The findings support the hypothesis that end-stage renal disease is part of an incomplete, multigenic susceptibility to chronic renal failure in the population studied. Further studies are needed to evaluate why an enhanced predisposition to kidney dysfunction and renal failure exists in relatives of an affected family member.
Since patients with Crohn's disease have a high risk of rejection after [transplant](https://www.withpower.com/clinical-trials/transplant), tcd601 may be a useful tool to manage and reduce the relapse rate. (https://research.cdlib.org/tcd/homepage/tcd603.asp).
Although tcd601 caused less nausea and constipation than previously described, our results suggest that tcd601 cannot be recommended to all renal transplant candidates. Furthermore, while most patients experienced transient nausea, only 1 patient experienced nausea that persisted longer than 25 minutes after tcd601 dosing, and the patient did not experience pain or emesis.