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

Sponsor

Eledon Pharmaceuticals (Industry)

Overall Status

Enrolling by invitation

CT.gov ID

NCT06126380

Collaborator

(none)

132

Enrollment

Location

Arms

73.2

Anticipated Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Kidney Transplant Rejection	Drug: AT-1501 Drug: Tacrolimus	Phase 2

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

132 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 25, 2023

Anticipated Primary Completion Date :

Dec 1, 2029

Anticipated Study Completion Date :

Dec 1, 2029

Arms and Interventions

Arm	Intervention/Treatment
Experimental: AT-1501 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	Drug: 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 Other Names: Tegoprubart
Active Comparator: 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	Drug: 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

Arm

Intervention/Treatment

Experimental: AT-1501

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

Drug: 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

Other Names:

Tegoprubart

Active Comparator: 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

Drug: 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

Outcome Measures

Primary Outcome Measures

Safety and Tolerability - Incidence of Treatment Emergent Adverse Events [Assessed from date of enrollment through Month 48]
Incidence of treatment-emergent serious adverse events (TESAEs), treatment-emergent adverse events (TEAEs), and treatment-emergent AEs of special interest (TEAEoSI).
Safety and Tolerability - Kidney Transplant Medication Side Effects [Assessed from date of enrollment through Month 48]
Kidney transplant medication side effects using the Modified Transplant Symptom Occurrence and Symptom Distress Scale-59 (MTSOSD) at baseline and 12, 24, 36, and 48 months.

Secondary Outcome Measures

The proportion of patient and graft survival at 12, 24, 36, and 48 months [Assessed from date of enrollment through Month 48]
A participant is considered to have graft functional impairment if they have an eGFR <60 mL/min/1.73m^2.
The proportion of participants with Graft function impairment at 12, 24, 36, and 48 months [Assessed from date of enrollment through Month 48]
A participant is considered to have graft functional impairment if they have an eGFR <60 mL/min/1.73m^2.
Proportion of participants with BPAR at 12, 24, 36, and 48 months [Assessed from date of enrollment through Month 48]
The Proportion of participants with BPAR at 12, 24, 36, and 48 months.
Proportion of composite endpoint (graft failure, BPAR, or death) at 12, 24, 36, and 48 months [Assessed from date of enrollment through Month 48]
The Proportion of participants with composite endpoint (graft failure, BPAR, or death) at 12, 24, 36, and 48 months.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts 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.