Daratumumab and Belatacept for Desensitization

Summary

Some kidney transplant candidates have a very low chance of getting a kidney transplant because their immune systems are "highly sensitized" to most kidney donors. Being "highly sensitized" means that they will likely have to wait a long time (more than 5 years) before an acceptable donor is found for them or, they never receive a compatible donor, and die on waitlist. The purpose of this study is to find out whether two drugs, daratumumab (Darzalex®), and belatacept (Nulojix®), can make these kidney transplant candidates less sensitized, and make it easier and quicker to find a kidney donor for them.

Conditions

• Highly Sensitized Prospective Kidney Transplant Recipients

Interventions

BIOLOGICAL

daratumumab

Daratumumab is a CD38 (Cluster of Differentiation 38)-directed cytolytic monoclonal antibody indicated for the treatment of multiple myeloma. In this study, daratumumab will be used in highly sensitized subjects without myeloma who are awaiting a kidney transplant. Definition of highly sensitized: Potential kidney transplant recipients with either: * calculated panel reactive antibodies (cPRA) ≥99.9% awaiting deceased donor transplant, or * cPRA \>98% (with \>5 years of waiting time) awaiting living donor transplant

BIOLOGICAL

belatacept

Belatacept, a monoclonal antibody, is indicated for the prophylaxis of organ rejection in adult patients receiving a kidney transplant. In this study, belatacept will be used in subjects who have not received a kidney transplant.

PROCEDURE

Bone marrow aspiration

Subjects will undergo a bone marrow aspiration prior to starting the study regimen and at 12 weeks after starting the study regimen. In subjects who undergo a kidney transplant during the study, another bone marrow aspiration will be done if it has been \>4 weeks since the previous bone marrow aspiration.

Sponsors & Collaborators

• Immune Tolerance Network (ITN)

  collaborator NETWORK

• Bristol-Myers Squibb

  collaborator INDUSTRY

• PPD Development, LP

  collaborator INDUSTRY

• Rho Federal Systems Division, Inc.

  collaborator INDUSTRY

• National Institute of Allergy and Infectious Diseases (NIAID)

  lead NIH

Principal Investigators

• Flavio G. Vincenti · UCSF Kidney Transplant Research

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-11-01

Primary Completion

2027-03-31

Completion

2028-04-30

FDA Drug

Yes

Countries

• United States

Study Locations