Tegoprubart for Kidney Transplant Rejection

Recruiting in Palo Alto (17 mi)

+17 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Eledon Pharmaceuticals

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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

Eligibility Criteria

This trial is for kidney transplant recipients who completed a prior study and consent to continue. They must understand the study, not join other trials, and if of childbearing potential, use effective contraception. Women must be sterile, postmenopausal or have a negative pregnancy test; men must also agree to contraception.

Inclusion Criteria

You promise not to join another research study while taking part in this treatment.

I am a man and agree to use effective birth control and not donate sperm for 90 days after the last dose of the study drug.

I am either not able to have children, past menopause, or will use effective birth control during the study.

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Treatment Details

Interventions

AT-1501 (Monoclonal Antibodies)
Tacrolimus (Immunosuppressant)

Trial OverviewThe trial compares long-term safety and effectiveness of two drugs in preventing kidney transplant rejection: Tegoprubart (AT-1501) versus Tacrolimus. Participants previously involved in related research will receive one of these treatments to determine which is better over time.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: AT-1501Experimental Treatment1 Intervention

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

Group II: TacrolimusActive Control1 Intervention

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