BESTOW-EXTENSION: A Phase 2, Multicenter, Open-Label Extension Study to Evaluate the Long- Term Safety and Efficacy of Tegoprubart in Kidney Transplant Recipients
EU CTIS ID: 2023-503337-21-00
What this study is testing
To assess the long-term safety of tegoprubart 20 mg/kg intravenous (IV) as part of a regimen along with mycophenolate mofetil (MMF) or mycophenolate sodium (MPS) in kidney transplant recipients.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- A participant meeting the following criteria at the time of baseline will be considered for admission to the study: Successfully completed qualifying Parent study, where entry into the OLE was offered;
- Continue to be able to understand the key components of the study as described in the written ICF, and is willing and able to provide written informed consent
- Agree not to participate in another interventional study while on treatment
- If female, is surgically sterile or 2 years postmenopausal. Women of childbearing potential may be enrolled if a pregnancy test is negative at baseline. Women of childbearing potential and men with partners that are of childbearing potential must agree to use highly effective methods of contraception from baseline through 120 days after the last administration of the study drug. Examples of acceptable methods of contraception are described in Table 6 and Table 7 (UK only)
- If male, agree to use a medically accepted highly effective method of contraception and agree to use this method for 120 days after last administration of the study drug and agree to not donate sperm for 120days after last administration of the study drug
You likely can't join if
- A participant who meets any of the following criteria will be excluded from this study: Unwilling or unlikely to comply with the study requirements, in the opinion of the Investigator
- Met any of the stopping criteria or discontinued study drug in the Parent study
- Pregnant or breastfeeding
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- Australia
- Brazil
- United States
- Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; Australia; Brazil; United States; Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.