CompletedPhase 2

A Study to Evaluate the Safety and Efficacy of Dual Costimulation Blockade With VIB4920 and Belatacept for Prophylaxis of Allograft Rejection in Adults Receiving a Kidney Transplant

United States25 participantsStarted 2019-10-30

Plain-language summary

The purpose of this study is to evaluate the efficacy, safety and tolerability of dual costimulation blockade with VIB4920 in combination of belatacept in adult male or female recipients of a renal allograft from a deceased, living unrelated or human leukocyte antigen (HLA) non-identical living related donor.

Who can participate

Age range18 Years – 70 Years

SexALL

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Inclusion criteria

✓. No donor specific antibodies (DSA), and
✓. Negative cross-match testing.

Exclusion criteria

✕. Aspartate aminotransferase (AST) \> 2.5 × upper limit of normal (ULN)
✕. Alanine aminotransferase (ALT) \> 2.5 × ULN
✕. Alkaline phosphatase (ALP) \> 2.5 × ULN
✕. Total bilirubin (TBL) \> 2 × ULN
✕. Hemoglobin \< 75 g/L
✕. Neutrophils \< 1.5 × 10\^9/L
✕. Platelets \< 100 × 10\^9/L
✕. In situ carcinoma of the cervix treated with apparent success with curative therapy \> 12 months prior to screening; or

What they're measuring

Percentage of Participants With Treated Biopsy-proven Acute Rejection (tBPAR) of Grade 1A or Higher, Graft Loss or Death at Week 24

Timeframe: Week 24

Trial details

NCT IDNCT04046549

SponsorAmgen

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-07-18

Results submitted2023-06-21

View on ClinicalTrials.gov More Allografts trials