Daratumumab + Belatacept for Kidney Transplant Candidates
(ATTAIN Trial)
Trial Summary
What is the purpose of this trial?
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.
Do I need to stop my current medications to join the trial?
The trial information does not specify if you need to stop taking your current medications. However, if you are currently on a biological drug, you cannot participate in the trial.
What data supports the effectiveness of the drug Belatacept for kidney transplant candidates?
Is the combination of Daratumumab and Belatacept safe for kidney transplant candidates?
Belatacept, used in kidney transplants, is generally well tolerated but can cause side effects like anemia, fever, and infections. It may also increase the risk of certain cancers and serious infections, especially in patients without prior exposure to the Epstein-Barr virus. Daratumumab's safety profile is not detailed here, but it is important to consult with healthcare providers for comprehensive safety information.14678
How is the drug combination of Daratumumab and Belatacept unique for kidney transplant candidates?
The combination of Daratumumab and Belatacept is unique because Belatacept is a novel immunosuppressive drug that helps prevent organ rejection by blocking T-cell activation, potentially reducing long-term kidney damage compared to traditional treatments. This combination may offer a new approach by integrating Daratumumab, which is typically used in other conditions, to enhance the effectiveness of Belatacept in kidney transplants.13468
Research Team
Flavio G. Vincenti
Principal Investigator
UCSF Kidney Transplant Research
Eligibility Criteria
This trial is for kidney transplant candidates who are highly sensitized (cPRA ≥99.9% or >98% with long wait times) and on hemodialysis, able to consent, HIV and Hepatitis C negative, immune to certain viruses like EBV and TB, not pregnant or nursing, willing to use contraception. Excluded are those with serious diseases besides kidney failure, past transplants or immunodeficiencies, recent infections requiring hospitalization or antibiotics.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive infusions of daratumumab and belatacept over a 10-week period in Cohort 1 or a 14-week period in Cohort 2
Follow-up
Participants are monitored for safety and effectiveness after treatment, including HLA antibody assessments and bone marrow aspiration
Post-transplant Follow-up
Participants who receive a kidney transplant are monitored for 52 weeks post-transplant
Treatment Details
Interventions
- Belatacept
- Bone marrow aspiration
- Daratumumab
Belatacept is already approved in United States, European Union for the following indications:
- Prophylaxis of organ rejection in adult patients receiving a kidney transplant
- Prophylaxis of organ rejection in adult patients receiving a kidney transplant
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Institute of Allergy and Infectious Diseases (NIAID)
Lead Sponsor
PPD DEVELOPMENT, LP
Industry Sponsor
David Simmons
PPD DEVELOPMENT, LP
Chief Executive Officer since 2012
BSc in Applied Science from Georgia Institute of Technology
Martina Flammer
PPD DEVELOPMENT, LP
Chief Medical Officer since 2024
MD
Immune Tolerance Network (ITN)
Collaborator
Rho Federal Systems Division, Inc.
Industry Sponsor
PPD
Industry Sponsor
Dr. Austin Smith
PPD
Chief Medical Officer since 2020
Doctor of Medicine from the Royal College of Surgeons in Ireland
David Simmons
PPD
Chief Executive Officer since 2012
Bachelor’s degree in Applied Mathematics and Industrial Management from Carnegie Mellon University
Bristol-Myers Squibb
Industry Sponsor
Christopher Boerner
Bristol-Myers Squibb
Chief Executive Officer since 2023
PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis
Deepak L. Bhatt
Bristol-Myers Squibb
Chief Medical Officer since 2024
MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania