Study of Tegoprubart Efficacy and Safety Compared With Tacrolimus in Kidney Transplantation

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorEledon Pharmaceuticals

About this trial

This study will evaluate the efficacy and safety of tegoprubart compared with tacrolimus in adult participants undergoing first kidney transplantation.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Undergoing kidney transplant with a living or deceased donor kidney

Adult participants that have reached the age of consent and are ≥18 years of age

Written informed consent prior to any study assessment

Disqualifiers

Conditions or circumstances that, in the investigator's judgment or according to protocol-defined criteria, would make participation unsafe, interfere with study assessments, or compromise protocol compliance.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Tegoprubart

    Drug

    Tegoprubart administered via IV infusion

  • Tacrolimus

    Drug

    Tacrolimus administered orally

Treatment groups

620 Participants
are divided into 2 treatment groups
Group A: Investigative ArmExperimental treatment 1 intervention
Group B: Comparator ArmActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Efficacy failure rate at 12 months post-transplant, defined as the first occurrence of biopsy proven acute rejection, graft loss, or death

Time frame
12 months post-transplant

Secondary outcomes

1

Proportion of participants with for-cause biopsy proven acute rejection, graft loss, or death

Time frame
12 months post-transplant
2

Participant and graft survival

Time frame
12 months post-transplant
3

iBox score at 12 months post-transplant survival

iBox is the validated tool for predicting the risk of kidney transplant loss based on artificial intelligence. Range of score is 0%-100%, higher score indicates better kidney survival.

Time frame
12 months post-transplant
4

Mean Renal graft function as assessed by estimated glomerular filtration rate

Time frame
12 months post-transplant

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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