AT-1501 for Kidney Transplantation

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
McGill University Health Care Centre, Montréal, Canada
Kidney Transplantation
AT-1501 - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

Safety, Pharmacokinetics, and Efficacy of AT 1501 in Patients Undergoing Kidney Transplant

See full description

Treatment Effectiveness

Study Objectives

This trial is evaluating whether AT-1501 will improve 9 primary outcomes and 8 other outcomes in patients with Kidney Transplantation. Measurement will happen over the course of Day 1 and at steady state Month 3.

Month 15
Incidence of DSA
12 months post-transplant
Rate of composite endpoint
Month 15
Incidence of donor derived cell free DNA (dd-cfDNA)
Month 12
Incidence of BPAR
Month 3
Pharmacodynamic Studies
Month 3
Pharmacokinetic- (Vdss)
Pharmacokinetic- (t1/2)
Pharmacokinetic- Area under the plasma concentration
Pharmacokinetic- CL
Pharmacokinetic- Cmax
Pharmacokinetic- Ke
Pharmacokinetic- PK profile
Pharmacokinetic- Tmax
Month 1
Trough levels of AT-1501
Month 3
Change in eGFR
Month 1
Anti-AT-1501 antibody studies
Month 20
Safety Incidences

Trial Safety

Trial Design

1 Treatment Group

AT-1501 Single Arm
1 of 1
Experimental Treatment

This trial requires 12 total participants across 1 different treatment group

This trial involves a single treatment. AT-1501 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 1 & 2 and have already been tested with other people.

AT-1501 Single Arm
Drug
AT-1501 monoclonal antibody targeting CD40L given as an IV infusion
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AT-1501
2020
Completed Phase 2
~60

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 1, 3, 6, 9, 12, and 15 months post-transplant and at the time of for cause biopsies
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 1, 3, 6, 9, 12, and 15 months post-transplant and at the time of for cause biopsies for reporting.

Closest Location

McGill University Health Care Centre - Montréal, Canada

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received newly diagnosed for Kidney Transplantation. There is one eligibility criterion to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Male or female ≥ 18 years of age

Patient Q&A Section

What causes kidney transplantation?

"There are many possible reasons for having a [kidney transplant](https://www.withpower.com/clinical-trials/kidney-transplant), but the most common are a loss of working capacity and chronic kidney failure. However, there is a trend towards increased use of renal transplantation in younger patients. In addition to the need for more long term experience in transplantation, our data support the view that more research is needed on the treatment of kidney failure and the factors influencing the outcome of kidney transplantation." - Anonymous Online Contributor

Unverified Answer

Can kidney transplantation be cured?

"Until the pathophysiologic mechanisms that lead to end-stage renal disease are fully understood, kidney transplantation cannot be predicted on an individual basis and can be only curative not in a definitive sense." - Anonymous Online Contributor

Unverified Answer

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

"Over 250,000 patients are on waiting lists for a deceased-donor kidney transplant annually in the United States. The average waiting time for kidney transplantation as of 1997 was 11.7 months, which represents one of the longest waiting periods known in the developed world at the end of the 20th century." - Anonymous Online Contributor

Unverified Answer

What is kidney transplantation?

"Transplantation of a new kidney to a non-relative donor is an option for some patients who cannot find a spouse and who are not prepared to wait for a spouse to become available. The donor must have a well-defined medical history, be free of diseases predisposing to immunological responses, and accept the risks of the operation." - Anonymous Online Contributor

Unverified Answer

What are common treatments for kidney transplantation?

"While kidney transplantation is the standard for the management of end-stage kidney disease, other possible methods of renal replacement therapy may be used to minimize the need for frequent dialysis treatment.\n" - Anonymous Online Contributor

Unverified Answer

What are the signs of kidney transplantation?

"Symptoms and signs in [kidney transplant](https://www.withpower.com/clinical-trials/kidney-transplant) recipients are a combination of those of the underlying disease, its treatment, the transplantation, and specific interactions between the two. Often, multiple diagnoses may share the same symptoms. Some symptoms do not have an identifiable cause or are non-specific, suggesting a diagnosis of a systemic disorder." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of kidney transplantation?

"The 5-year incidence of primary AK in KT recipients is approximately 7.1%; however, these patients were older and have an increased risk of developing CAKD compared with the primary KT recipients. The incidence of CAK was not significantly higher in patients with primary AK." - Anonymous Online Contributor

Unverified Answer

What is the latest research for kidney transplantation?

"There seems to be a need for a national registry to monitor long-term outcomes and outcomes of [kidney transplant](https://www.withpower.com/clinical-trials/kidney-transplant)s. In addition, a multidisciplinary approach of transplant specialists with good training in transplant epidemiology is recommended to maintain good outcomes of kidney transplants in Pakistan." - Anonymous Online Contributor

Unverified Answer

Is at-1501 safe for people?

"From this study, the most frequent event that was observed was grade 1 upper airways irritation, and no one required treatment. The only grade 3 event of at least concern was skin irritation at the injection site for the donor/recipient of the transplant." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets kidney transplantation?

"According to the American Association of Kidney Patient Associations' list on [transplant](https://www.withpower.com/clinical-trials/transplant) wait list, an average age of 61 was reported as the time when someone in America received a kidney transplantation, with a standard deviation of 5.7 years. However, if a person born is considered as a person, then he would have to wait about 17 years to get a kidney transplant. In Iran, with a fertility rate of about 1 to 0.05 per woman, the average age of a woman getting a kidney transplantation before having a baby is 36 years old, with a standard deviation of 5 yr, which means a woman could maybe get a transplant at 44 years old." - Anonymous Online Contributor

Unverified Answer

Has at-1501 proven to be more effective than a placebo?

"At-1501 proved superior to placebo in preventing CIT and TACR, and was well tolerated. However, there was no difference between the two treatment groups in terms of graft function. The effect of at-1501 on CIT seems to be independent of the baseline graft function. This trial was registered with European Clinical Trials Database: EUDRACT2000-002654." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving at-1501?

"No additional clinical data or trials with at-1501 have been published in the literature. We believe that additional clinical data in this area is worthwhile, and such data may illuminate aspects of at-1501's benefit and toxicity profile." - Anonymous Online Contributor

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