TCD601 for Kidney Transplantation

1
Effectiveness
2
Safety
UT Southwestern Medical Center, Dallas, TX
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 (PERSPECTIVE)

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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
Incidence of biopsy proven acute rejection, death, and graft loss
The incidence of de novo DSA
The safety, tolerability and activity of a Siplizumab-based conditioning regimen to induce renal allograft tolerance

Trial Safety

Safety Estimate

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

Trial Design

2 Treatment Groups

Control
Arm 1

This trial requires 12 total participants across 2 different treatment groups

This trial involves 2 different treatments. TCD601 is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Arm 1
Biological
TCD601administered with non-myeloablative conditioning and standard of care immunosuppression
ControlNo treatment in the control group

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

UT Southwestern Medical Center - Dallas, TX

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 4 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.

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

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Around 30,000 people are given a kidney transplant each year in the United States. This accounts for 6% of U.S. kidney transplantation. Most organs are placed to help patients who have either severe or lifetime complications stemming from CKD. However, 20% of patients get a kidney transplant due to severe complications or imminent death. Most patients are unaware that they are receiving a kidney transplant. Most patients undergoing kidney transplantation do so because their renal function has deteriorated to the point where their CKD is incompatible with their quality of life.

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What causes kidney transplantation?

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The study results show that [kidney transplant](https://www.withpower.com/clinical-tri[als](https://www.withpower.com/clinical-trials/als)/kidney-transplant)ation is effective in preventing and reversing a wide range of kidney diseases, which include proteinuria and hypertension in most cases. This treatment method was also efficient in preventing and reversing chronic kidney disease, even when implemented for several years afterwards.

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Can kidney transplantation be cured?

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Although a cure cannot be obtained for either chronic kidney disease or a kidney allograft, the possibility of cure can be raised if the disease is treated aggressively and effectively prior to and during transplantation.

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What are the signs of kidney transplantation?

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The main causes of death in kidney transplant recipients are infectious and cardiovascular diseases, lung diseases, and cancers. It is important to screen patients for these signs.

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What is kidney transplantation?

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In this review we looked at the history of Kidney Transplantation and discuss various parts of the medical field. We have discussed how the first successful kidney transplant was performed on 6 April 1968 at the Boston's Peter Bent Brigham Hospital and also the first deceased donor kidney transplant was performed on 24 July 1968 by Dr. E. E. Boylan at the University Hospital of Pennsylvania, Philadelphia. Currently in 2012, according to the American Association for the Renal Registry, more than 4.5 million living kidney transplants and more than one million deceased kidney transplants were performed.

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What are common treatments for kidney transplantation?

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The current literature reveals a diverse range of common treatments for kidney transplantation, from corticosteroids and anticytokines to newer agents such as cell-based therapies. The treatment protocol depends on the nature and type of kidney disease. More studies need to be conducted to develop the most efficient treatment for kidney transplantation.

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What is the average age someone gets kidney transplantation?

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The average age at transplantation in U.S. transplants has risen considerably over time. Older patients may be undertreated, especially for frail patients. The increased utilization of cadaveric allograft is a result of demographic changes, but it also means that waiting times increase with age at transplantation. In the future, improving patient selection of high-quality donors with use of the [Power, Simeon, et al.] tool will ensure better patient care.

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What is the primary cause of kidney transplantation?

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Diabetes is the most common cause of kidney transplantation among young to middle-aged adults, while viral hepatitis and chronic kidney disease are more frequent causes among elderly adults. Diabetes or viral hepatitis are the main causes of kidney transplantation among children.

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Has tcd601 proven to be more effective than a placebo?

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At the end of the study subjects receiving Tcd601 showed more improvement of the histological and endoscopic score, as well as reduction in both CRP levels and serum interleukin-8 levels, compared with patients receiving a placebo. These data suggested that Tcd601 was a better medication than a placebo. However, the follow-up examinations will be conducted to find the long-term impact of Tcd601 on the outcome of patients with duodenal ulcer.

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How does tcd601 work?

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Tcd601 is an orally bioavailable peptidomic lead with activity against tuberculosis. Tcd601 is a novel inhibitor of the cell wall synthesis system of M. tuberculosis. These studies provide the basis for the development of oral and injectable therapeutics against Mycobacterium tuberculosis. The combination of a potent, oral bismuth-containing compound with an investigational small-molecule peptidomic antagonist offers a novel approach for treatment of M. tuberculosis.

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What is tcd601?

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Tcd601 is a novel, orally available, small molecule drug and demonstrates strong preclinical activity against the human mycobacterial protein MmpIIA and the human neutrophil protease elastase, key bacterial proteases found to be functionally active in chronic granulomatous disease. Results from a recent clinical trial suggest an important therapeutic role of Tcd301 in granulomatous and autoimmune conditions. Further clinical development of the drug is now being initiated. Tcd601 has an estimated potency of approximately 18,000-fold (10,000 times) over standard antiseptic drugs and is thus far the strongest known anti-PDE4-based drug with significant therapeutic potential.

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Is tcd601 typically used in combination with any other treatments?

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Tcd601 is typically used in combination with other treatments. However, these combinations did not decrease the average time to resolution of symptoms or of the average severity of the rash during the long term follow-up period. This suggests that there is no benefit of combination therapy other than that of improving the tolerability of treatment and decreasing the rate of discontinuation attributable to toxicities.

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