Phase 4
N=20
Comparison of Tacrolimus Extended-Release (Envarsus XR) to Tacrolimus Immediate-Release in Human Leukocyte Antigen (HLA) Sensitized Kidney Transplant Recipients
Kidney Transplant Rejection
Bottom Line
View on ClinicalTrials.gov: NCT04225988 ↗Enrolled (actual)
20
Serious AEs
60.0%
Results posted
Jul 2024
Primary outcome: Primary: Number of Participants With Biopsy-proven Acute Rejection — 1; 2 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Extended-release tacrolimus (Drug); Immediate-release tacrolimus (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Cedars-Sinai Medical Center
- Primary completion
- Jul 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Biopsy-proven Acute Rejection |
1; 2 | — |
| SECONDARY Number of Participants With de Novo Donor-specific Antibodies |
1; 1 | — |
| SECONDARY Number of Persistent Pre-existing Donor-specific Antibodies |
1; 2 | — |
| SECONDARY Estimated Glomerular Filtration Rate (eGFR; Chronic Kidney Disease (CKD)-Epi Equation) |
58; 59 | — |
| SECONDARY Level of Donor-derived Cell-free DNA (Allosure) |
0.599; 1.343; 1.166; 2.093 | — |
Summary
This is a randomized, open-label, controlled clinical trial designed to compare clinical outcomes after kidney transplantation using extended-release tacrolimus (Envarsus XR) versus immediate tacrolimus among highly-sensitized kidney transplant recipients. Outcomes to be assessed include the incidence of biopsy-proven acute rejection at 12 months, the presence of de novo and pre-existing donor-specific HLA antibodies, estimated glomerular filtration rate, and the level of donor-derived cell-free DNA.
Eligibility Criteria
Inclusion Criteria
- Recipient of a deceased or living donor kidney allograft
- Patients must have undergone desensitization with Intravenous Immunoglobulin (IVIG) and rituximab with or without plasma exchange prior to transplant or be administered IVIG and rituximab peri-operatively (within seven days of transplant) post-transplant
- Age 18 and over
- Able to understand and provide informed consent
- At transplant, patient must have an acceptable crossmatch [as defined by a T- or B-flow crossmatch ≤ 225 median channel shift (MCS)] from a non-HLA identical donor. A negative crossmatch is defined as a T pronase flow crossmatch < 70 MCS or a T- flow crossmatch < 50 MCS and a B pronase flow crossmatch <130 MCS or a B-flow crossmatch <100 MCS.
Exclusion Criteria
- Recipients of a dual simultaneous kidney/liver, kidney/heart, kidney/lung, or kidney/pancreas transplant.
- History of hypersensitivity to any of the study drug or to drugs of similar chemical classes.
- Patients with a clinically significant systemic infection within 30 days prior to transplant.
- Patients who have any history of a surgical or medical condition that may affect absorption of drug, such as severe diarrhea, active peptic ulcer disease, or uncontrolled diabetes mellitus, which in the opinion of the investigator at the time of enrollment, might significantly alter the absorption, distribution, metabolism and/or excretion of study medication.
- Women of childbearing potential who are either pregnant, lactating, planning to become pregnant during this trial, or with a positive serum or urine pregnancy test. Women of childbearing potential must be willing to agree to contraceptive practices.
- Patients who are Polymerase Chain Reaction (PCR) positive for hepatitis B, hepatitis C, or HIV.
Data sourced from ClinicalTrials.gov (NCT04225988). 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.