Phase 4
N=20
Mechanisms of Belatacept Effect on Alloimmunity and Antiviral Response After Kidney Transplantation (BMS IM 103-309)
Renal Transplant Rejection
Bottom Line
View on ClinicalTrials.gov: NCT01953120 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Dec 2022
Primary outcome: Primary: Antibody and T Cell-mediated Immune Response — 17; 0; 0; 1 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Belatacept (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, Los Angeles
- Primary completion
- Apr 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Antibody and T Cell-mediated Immune Response |
17; 0; 0; 1; 0 | — |
| SECONDARY Post-transplant de Novo Donor Specific Antibody (DSA) |
— | — |
Summary
This research evaluates the effectiveness of a new drug called belatacept (Nulojix) for the prevention of acute rejection and preservation of kidney function in transplant patients. Belatacept was approved in 2011 by the United States Food and Drug Administration (FDA) and is being marketed as Nulojix. The pharmaceutical company sponsoring this study is Bristol-Myers Squibb.
Belatacept is a prescription medicine used in adults to prevent transplant rejection in people who have received a kidney transplant. Transplant rejection happens when the body's immune system senses that the new transplanted kidney is different or foreign, and attacks it. Belatacept is used with corticosteroids and certain other medicines to help prevent rejection of your new kidney.
The purpose of the research is to understand whether the new drug, belatacept, is better than other anti-rejection drugs, such as cyclosporine and tacrolimus that are typically used in the treatment against kidney rejection in transplant patients.
Eligibility Criteria
Inclusion Criteria
- The subject is willing to provide signed written informed consent Target Population
- The subject is a first-time recipient of a living or deceased donor kidney transplant
- Evidence of calcineurin inhibitor side effects during the first 3 months after transplant as defined as
- Neurologic toxicity, defined as tremor, altered mental status, or seizure 2. Renal toxicity, defined as glomerular filtration rate (GFR) =10 mg by mouth daily for patients less than 6 weeks post-transplantation, and at >=5mg by mouth daily for patients greater than 6 weeks post-transplantation at the time of study entry.
Exclusion Criteria
- WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 8 weeks after the last infusion.
- Women who are pregnant or breastfeeding
- Women with a positive pregnancy test on enrollment or prior to study drug administration
- Males unwilling or unable to use an adequate method of contraception for the entire study period and for up to 8 weeks after the last infusion of study medication Immunologic status
- Subjects with panel reactive antibody (PRA) ≥ 30% at time of transplant
- Subjects with zero human leukocyte antigen (HLA) mismatched donors (either from related or unrelated donor)
- Subjects with any prior solid organ transplant (including kidney)
- Subjects receiving a concurrent solid organ (heart, liver, pancreas) or cell (islet, bone marrow, stem cell) transplant
- Subjects with a history of biopsy-proven acute rejection post-transplant (humoral or cellular) in the first three months post transplantation Infection related risks
- Subjects who are hepatitis C antibody-positive or polymerase chain reaction (PCR)-positive for hepatitis C
- Subjects who are hepatitis B surface antigen-positive or PCR-positive for hepatitis B
- Subjects with known human immunodeficiency virus (HIV) infection
- Subjects with active tuberculosis (TB) requiring treatment within the previous 3 years or any subject who previously required triple (or more) combination therapy for TB.
- Subjects who are Epstein-Barr virus (EBV) antibody negative and have received grafts from EBV antibody positive donors.
Prohibited Therapies and/or Medications
- Subjects who have used any investigational drug within 30 days prior to the Day 1 visit
- Subjects previously treated with belatacept
- Use of mammilian target of rapamycin (mTOR) inhibitors at any time after transplantation
Data sourced from ClinicalTrials.gov (NCT01953120). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.