Long-Term Safety and Efficacy of Tegoprubart in Kidney Transplant Recipients

Официальное название

AT-1501-K209: BESTOW-EXTENSION: A Phase 2, Multicenter, Open-Label Extension Study to Evaluate the Long-Term Safety and Efficacy of Tegoprubart in Kidney Transplant Recipients

Обзор

This study will evaluate the long term safety and efficacy of AT-1501 (tegoprubart) compared with tacrolimus in patients undergoing kidney transplantation.

Подробное описание

This is a multicenter, open-label, active control extension study to assess the long-term safety and efficacy of AT-1501 (tegoprubart) compared with tacrolimus in the preservation of allograft function after kidney transplantation.

The number of patients enrolled for OLE study will depend on the enrollment in the Parent studies. To be eligible for participation in this study, participants must have completed a designated Parent study.

Participants in this study will continue the treatment regimen they were receiving in the Parent study. Dose regimens will include either AT-1501 (tegoprubart) or tacrolimus.

Вмешательства

• Препарат AT-1501
  AT-1501 20 mg/kg administered every 3 weeks IV + MMF 1000 mg PO twice daily (BID) or MPS 720 mg PO BID + Corticosteroids 5 mg of prednisone PO once daily (QD) or equivalent
• Препарат Tacrolimus
  Tacrolimus dosed PO BID with the dose titrated to maintain a trough concentration of 6-8 ng/mL+ MMF 1000 mg PO BID or MPS 720 mg PO BID + Corticosteroids 5 mg of prednisone PO QD or equivalent

Первичные конечные точки

• Safety and Tolerability - Incidence of Treatment Emergent Adverse Events [Срок оценки: Assessed from date of enrollment through Month 48]
• Safety and Tolerability - Kidney Transplant Medication Side Effects [Срок оценки: Assessed from date of enrollment through Month 48]

Вторичные конечные точки (4)

• The proportion of patient and graft survival at 12, 24, 36, and 48 months [Срок оценки: Assessed from date of enrollment through Month 48]
• The proportion of participants with Graft function impairment at 12, 24, 36, and 48 months [Срок оценки: Assessed from date of enrollment through Month 48]
• Proportion of participants with BPAR at 12, 24, 36, and 48 months [Срок оценки: Assessed from date of enrollment through Month 48]
• Proportion of composite endpoint (graft failure, BPAR, or death) at 12, 24, 36, and 48 months [Срок оценки: Assessed from date of enrollment through Month 48]

Критерии участия

Критерии включения

• 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 90 days after the last administration of the study drug. Examples of acceptable methods of contraception are described in Table 6.
• If male, agree to use a medically accepted highly effective method of contraception and agree to use this method for 90 days after last administration of the study drug and agree to not donate sperm for 90 days after last administration of the study drug.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 26 центров

• University of California Los Angeles — Los Angeles
• Keck School of Medicine of USC — Los Angeles
• University of California, Irvine Medical Center — Orange
• University of California, Davis Medical Center — Sacramento
• Jacobs Medical Center at UC San Diego Health — San Diego
• MedStar Georgetown University Hospital — Washington D.C.
• Tampa General Hospital — Tampa
• Emory University Hospital — Atlanta
• … и ещё 18 центров

Испания · 5 центров

• Hospital del Mar - Parc de Salut Mar — Barcelona
• Hospital Universitari Vall d'Hebron — Barcelona
• Hospital Clinical de Barcelona — Barcelona
• Hospital Universitari de Bellvitge — Barcelona
• Hospital Germans Trias i Pujol — Barcelona

Франция · 4 центра

• Groupe Hospitalier Pellegrin — Bordeaux
• CHU Grenoble-Alpes - Hopital Nord Michallon — Grenoble
• Centre Hospitalier Universitaire Dupuytren — Limoges
• CHU de Toulouse - Hopital de Rangueil — Toulouse

Австралия · 2 центра

• Royal Adelaide Hospital — Adelaide
• Fiona Stanley Hospital — Perth

Бразилия · 2 центра

• Fundação Oswaldo Ramos - Hospital do Rim — São Paulo
• Hospital das Clínicas da Faculdade de Medicina de São Paulo — São Paulo

Канада · 2 центра

• St. Paul's Hospital — Vancouver
• McGill University Health Care Centre — Montreal

Германия · 1 центр

• Charite Universitatsmedizin Berlin — Berlin

Великобритания · 1 центр

• Oxford University Hospitals NHS Foundation Trust - John Radcliffe Hospital — Oxford

Идентификаторы

NCT: NCT06126380 · AT-1501-K209 · EU CTR · UTN

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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