TCD601 for Kidney Transplantation

Phase-Based Estimates
1
Effectiveness
2
Safety
University of Maryland, Baltimore, MD
TCD601 - Biological
Eligibility
18 - 65
All Sexes
Eligible conditions
Kidney Transplantation

Study Summary

A Study of TCD601 in the Induction of Tolerance in de Novo Renal Transplantation (PANORAMA)

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Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

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.

24 months
The incidence of biopsy proven acute rejection, death and graft loss
The incidence of de novo donor-specific antibody
The optimal regimen for renal allograft tolerance while minimizing chimeric transition syndrome

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

3 Treatment Groups

No Control Group
Arm 3

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.

Arm 3
Biological
TCD601administered with non-myeloablative conditioning and standard of care immunosuppression
Arm 2
Biological
TCD601administered with non-myeloablative conditioning and standard of care immunosuppression
Arm 1
Biological
TCD601administered with non-myeloablative conditioning and standard of care immunosuppression

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 24 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 24 months for reporting.

Closest Location

University of Maryland - Baltimore, MD

Eligibility Criteria

This trial is for patients born any sex between 18 and 65 years old. You must have received newly diagnosed for Kidney Transplantation. There are 3 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Able to understand the study requirements and provide written informed consent before and study assessment is performed
Male or female patients ≥ 18 to 60 years of age
Recipient of a first or second renal transplant from a non-HLA identical, but at least haploidentical, ABO compatible living donor Key

Patient Q&A Section

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

What are the signs of kidney transplantation?

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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.

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How many people get kidney transplantation a year in the United States?

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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.

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What are common treatments for kidney transplantation?

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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.

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What causes kidney transplantation?

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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.

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Can kidney transplantation be cured?

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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.

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What is kidney transplantation?

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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.

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Have there been any new discoveries for treating kidney transplantation?

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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.

Unverified Answer

What are the common side effects of tcd601?

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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.

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How serious can kidney transplantation be?

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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.

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Does kidney transplantation run in families?

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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.

Unverified Answer

What is tcd601?

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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).

Unverified Answer

Is tcd601 safe for people?

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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.

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