Clinical trial

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

Name

AT-1501-K209

Description

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

Trial arms

Trial start

2023-10-25

Estimated PCD

2029-12-01

Trial end

2029-12-01

Phase

Early phase I

Treatment

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

Arms:

AT-1501

Other names:

Tegoprubart

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

Arms:

Tacrolimus

Size

132

Primary endpoint

Safety and Tolerability - Incidence of Treatment Emergent Adverse Events

Assessed from date of enrollment through Month 48

Safety and Tolerability - Kidney Transplant Medication Side Effects

Assessed from date of enrollment through Month 48

Eligibility criteria

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 132, 'type': 'ESTIMATED'}}

Updated at

2023-11-13

1 organization

2 products

1 indication

Organization

Eledon Pharmaceuticals

Product

Tacrolimus

Indication

Kidney Transplant Rejection

Product

AT-1501