Comparison of Tacrolimus Extended-Release (Envarsus XR) to Tacrolimus Immediate-Release in HLA Sensitized Kidney Transplant Recipients

• Status: Recruiting
• Trial end date: 2022-06-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cedars-Sinai Medical Center
• Collaborator: Veloxis Pharmaceuticals
• Treatments: Antibodies; Immunoglobulins; Tacrolimus

Criteria

Inclusion Criteria:

1. Recipient of a deceased or living donor kidney allograft

2. Patients must have undergone desensitization with 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

3. Age 18 and over

4. Able to understand and provide informed consent

5. 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:

1. Recipients of a dual simultaneous kidney/liver, kidney/heart, kidney/lung, or kidney/pancreas transplant

2. History of hypersensitivity to any of the study drug or to drugs of similar chemical classes

3. Patients with a clinically significant systemic infection within 30 days prior to transplant

4. 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.

5. 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.

6. Patients who are PCR positive for hepatitis B, hepatitis C, or HIV.