Status:
ACTIVE_NOT_RECRUITING
Evaluation of Anti-rejection Drug, Tacrolimus, in African-Americans With Kidney Transplant
Lead Sponsor:
The Methodist Hospital Research Institute
Collaborating Sponsors:
Veloxis Pharmaceuticals
Conditions:
Kidney Disease, End-Stage
Donor Specific Antibodies
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
In spite of conventional immunosuppression with lymphocyte-depleting induction followed by tacrolimus- and mycophenolate-based regimens, African American (AA) renal transplant recipients experience hi...
Detailed Description
Phase 4 (post-marketing) De novo African American living or deceased donor renal transplant recipients 18 to 65 years of age Number of subjects to be enrolled: 60 All patients will receive standard i...
Eligibility Criteria
Inclusion
- • Primary live donor or deceased donor renal allograft
- African American patients aged 18 to 65 years
- Ability to take oral medications
- Not currently on medications known to significantly interfere with tacrolimus metabolism, e.g. strong CYP3A4 inducers or inhibitors including but not limited to rifampin, rifabutin, phenytoin, carbamazepine, phenobarbital, protease inhibitors, azole antifungal (voriconazole, itraconazole, posaconazole, ketoconazole)
- o Note: All patients will be discharged on clotrimazole 10 mg three times daily for one month for thrush prophylaxis, a known mild-to-moderate CYP3A4 inhibitor
- Female subjects of childbearing potential:
- Not current pregnant
- Agree not to try to become pregnant during the study period
- Agree to consistently use two forms of highly effective birth control throughout the study period
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
Exclusion
- • Presence of a positive T- or B-cell flow cytometry allogeneic crossmatch
- Presence of pre-formed anti-human leukocyte antigen (HLA) donor-specific antibodies (DSAs)
- Recipient of an ABO-incompatible organ
- Receipt of a multi-organ or dual kidney transplant
- Receipt of pediatric en bloc deceased donor kidneys
- Receipt of deceased donor kidney with a kidney donor profile index (KDPI) greater than or equal to 85%
- Has undergone desensitization, or received antibody removal, anti-B-cell, or anti-plasma cell therapy in the 90 days preceding the transplant
- Planned initiation of antibody removal (i.e. plasmapheresis) within 7 days of the transplant procedure
- Positive test for latent tuberculosis (TB) and has not previously received adequate anti-microbial therapy or would require TB prophylaxis after transplant
- Uncontrolled concomitant infection that would not allow for targeting escalated tacrolimus trough concentrations, as deemed by prescriber
- Known infection or seropositivity for hepatitis B virus (HBV, defined by positive HBsAg, anti-HBcAg, or positive viral load) or hepatitis C virus (HCV) with active viral load
- Current malignancy
- Use of an investigational study in the 30 days prior to the transplant procedure
Key Trial Info
Start Date :
September 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2025
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT04665310
Start Date
September 1 2018
End Date
October 31 2025
Last Update
March 14 2025
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