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

Eledon Pharmaceuticals

Status and phase: Invitation-only; Phase 2

Conditions: Kidney Transplant Rejection

Treatments: Drug: AT-1501; Drug: Tacrolimus

Study type: Interventional

Funder types: Industry

Identifiers

NCT06126380

AT-1501-K209

UTN (Other Identifier)

EU CTR (Other Identifier)

Details and patient eligibility

About

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

Full description

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.

Enrollment: 132 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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132 participants in 2 patient groups

AT-1501

Experimental group

Description:

AT-1501 20 mg/kg administered every 3 weeks IV + MMF 1000 mg per os (orally) (PO) twice daily (BID) or MPS 720 mg PO BID + Corticosteroids 5 mg of prednisone PO once daily (QD) or equivalent

Treatment:

Drug: AT-1501

Tacrolimus

Active Comparator group

Description:

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

Treatment:

Drug: Tacrolimus