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

Kidney Transplant Rejection Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06126380
• Other study ID #: AT-1501-K209
• Secondary ID: EU CTRUTN
• Status: Enrolling by invitation
• Phase: Phase 2
• Start date: October 25, 2023
• Est. completion date: December 2029

Study information

• Verified date: May 2024
• Source: Eledon Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 132
• Est. completion date: December 2029
• Est. primary completion date: December 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Kidney Transplant Rejection

Intervention

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
• 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

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital	Adelaide	South Australia
Canada	McGill University Health Care Centre	Montréal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Eledon Pharmaceuticals

Countries where clinical trial is conducted

Australia,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and Tolerability - Incidence of Treatment Emergent Adverse Events	Incidence of treatment-emergent serious adverse events (TESAEs), treatment-emergent adverse events (TEAEs), and treatment-emergent AEs of special interest (TEAEoSI).	Assessed from date of enrollment through Month 48
Primary	Safety and Tolerability - Kidney Transplant Medication Side Effects	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.	Assessed from date of enrollment through Month 48
Secondary	The proportion of patient and graft survival at 12, 24, 36, and 48 months	A participant is considered to have graft functional impairment if they have an eGFR <60 mL/min/1.73m^2.	Assessed from date of enrollment through Month 48
Secondary	The proportion of participants with Graft function impairment at 12, 24, 36, and 48 months	A participant is considered to have graft functional impairment if they have an eGFR <60 mL/min/1.73m^2.	Assessed from date of enrollment through Month 48
Secondary	Proportion of participants with BPAR at 12, 24, 36, and 48 months	The Proportion of participants with BPAR at 12, 24, 36, and 48 months.	Assessed from date of enrollment through Month 48
Secondary	Proportion of composite endpoint (graft failure, BPAR, or death) at 12, 24, 36, and 48 months	The Proportion of participants with composite endpoint (graft failure, BPAR, or death) at 12, 24, 36, and 48 months.	Assessed from date of enrollment through Month 48