Europas førende søgning efter kliniske forsøg

At-1501

Clinical trials are investigating At-1501 in people who are having or have had a kidney transplant. These phase 2 studies look at safety, graft function, and how well the treatment helps prevent rejection of the transplanted kidney.

Table of contents

Trials overview

Two phase 2 clinical trials are studying At-1501 in the setting of kidney transplantation.[1][2] Both trials are focused on prophylaxis of renal allograft rejection, which means preventing the body from rejecting the new kidney.[1][2] Both studies are authorised and are being done as interventional trials, meaning the researchers give study treatment and then measure the results.[1][2]

The studies differ in their main goals.[1][2] One study looks at long-term safety and symptom burden after transplant, while the other compares kidney function at 12 months after transplant.[1][2]

BESTOW study

The study titled BESTOW is a phase 2, multicenter, randomized, open-label study in patients undergoing kidney transplantation.[2] It includes 192 participants and is authorised.[2] The brief summary says the study is designed to assess graft function at 12 months after transplant in participants treated with tegoprubart compared with participants treated with tacrolimus.[2]

In simple terms, this trial is asking whether At-1501 can help the transplanted kidney work well one year after surgery.[2] The main outcome is the estimated glomerular filtration rate (eGFR) at 12 months, which is a standard way to estimate how well the kidneys are filtering blood.[2]

The intervention list shows that the study includes At-1501 190 mg and At-1501 475 mg vial options, along with other transplant medicines used in the comparison groups.[2] The source data also names tegoprubart in the study summary, so At-1501 and tegoprubart are both used in the trial records provided.[2]

BESTOW-EXTENSION study

The BESTOW-EXTENSION study is a phase 2, multicenter, open-label extension study in kidney transplant recipients.[1] It includes 162 participants and is also authorised.[1] An extension study follows people after the main study to collect longer-term information.[1]

This study is designed to evaluate the long-term safety and efficacy of tegoprubart as part of a regimen with mycophenolate mofetil or mycophenolate sodium in kidney transplant recipients.[1] The brief summary says the study aims to assess long-term safety of tegoprubart 20 mg/kg intravenous treatment in this transplant setting.[1]

The main safety outcomes include treatment-emergent serious adverse events, treatment-emergent adverse events, and adverse events of special interest.[1] The study also measures changes in vital signs, clinical laboratory measures, and kidney transplant medication side effects using the Modified Transplant Symptom Occurrence and Symptom Distress Scale at baseline and at 12, 24, 36, and 48 months.[1]

Who can participate

Based on the trial records, the target population is people undergoing kidney transplantation or people who already received a kidney transplant.[1][2] The studies are not described as being open to the general public; they are focused on a specific transplant group.[1][2]

Because one study is a randomized study and the other is an open-label extension, participation may depend on whether someone is entering the transplant study for the first time or continuing follow-up after the main study.[1][2]

What is measured in the studies

The studies measure both safety and effectiveness outcomes.[1][2] Safety outcomes include serious adverse events, other adverse events, special interest safety events, vital signs, and lab results.[1]

Effectiveness outcomes include graft function at 12 months in the BESTOW study and long-term safety and efficacy in the extension study.[1][2] The extension study also uses the Modified Transplant Symptom Occurrence and Symptom Distress Scale, which is a questionnaire that tracks transplant-related symptoms and how troubling they are for the patient.[1]

The BESTOW study compares At-1501 with tacrolimus-treated participants, while the extension study follows participants over time to see how they do with longer treatment exposure.[1][2]

Key patient terms

  • Randomized means participants are placed into study groups by chance, which helps make the comparison fair.[2]
  • Open-label means the study team and the participant know which treatment is being used.[1]
  • Multicenter means the study is carried out at more than one hospital or clinic.[1][2]
  • Graft function means how well the transplanted kidney is working.[2]
  • Serious adverse event means a major health problem that happens during the study and needs careful medical attention.[1]
  • Clinical laboratory measures are blood or urine tests used to monitor health during the study.[1]
Trial ID Phase Condition studied Status Enrollment
2023-503336-41-00 Phase 2 Prophylaxis of renal allograft rejection Authorised 192
2023-503337-21-00 Phase 2 Prophylaxis of renal allograft rejection Authorised 162

FAQ

  • What is being studied in the At-1501 trials? The trials study At-1501 in kidney transplant recipients. They focus on whether it is safe and how well it helps protect the transplanted kidney.
  • Who can take part in these studies? The studies are for people undergoing kidney transplantation or kidney transplant recipients. One study also follows people after the transplant for long-term safety.
  • What phase are the At-1501 trials? Both trials are phase 2 studies. This means they are looking at early evidence of safety and how well the treatment works.
  • What conditions are these trials focused on? The trials focus on prophylaxis of renal allograft rejection. This means preventing the immune system from attacking the new kidney.
  • What main results are being measured? One study measures safety events, vital signs, lab tests, and transplant symptom scores over time. The other study measures kidney function at 12 months using eGFR, which is a blood-test-based estimate of how well the kidneys are working.

Igangværende kliniske forsøg for At-1501

  • Langtidsundersøgelse af lægemidlet tegoprubart til forebyggelse af organafstødning hos nyretransplanterede patienter

    Rekrutterer ikke

    1 1 1
    Undersøgte sygdomme:
    Undersøgte lægemidler:
    Frankrig Tyskland Spanien

  • Undersøgelse af ny medicin (tegoprubart) til forebyggelse af organafstødning efter nyretransplantation

    Rekrutterer ikke

    1 1 1
    Undersøgte sygdomme:
    Undersøgte lægemidler:
    Frankrig Tyskland Spanien

Ordliste

  • Kidney transplant: A surgery where a healthy kidney is placed into a person whose own kidneys are not working well enough.
  • Kidney transplant recipient: A person who has received a new kidney.
  • Renal allograft: The transplanted kidney. 'Allograft' means the organ came from another person.
  • Rejection: When the body’s immune system attacks the transplanted kidney because it sees it as foreign.
  • Prophylaxis: Treatment given to help prevent a problem before it happens.
  • Phase 2: An early clinical trial phase that looks at safety and signs that a treatment may work.
  • Open-label: A study design where the people in the study and the study team know which treatment is being given.
  • Randomized: Participants are assigned to treatment groups by chance, not by choice.
  • Multicenter: The study is done at more than one hospital or clinic.
  • eGFR: Estimated glomerular filtration rate, a number that helps show how well the kidneys are filtering blood.
  • Adverse event: Any unwanted medical problem that happens during a study, whether or not it is caused by the study treatment.

Referencer

  1. https://clinicaltrials.gov/study/2023-503337-21-00
  2. https://clinicaltrials.gov/study/2023-503336-41-00