Trial to Evaluate Safety and Tolerability of Tacrolimus Extended-Release (Astagraf XL) in HLA Sensitized Kidney Transplant Recipients

• Status: Active, not recruiting
• Trial end date: 2021-05-09
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to demonstrate the safety of tacrolimus extended-release in HLA sensitized (HS, defined as panel reactive antibody ≥ 30%), kidney transplant recipients after desensitization with intravenous immunoglobulin (IVIG) and rituximab +/- plasma exchange (PLEX) per the standard of care with alemtuzumab induction.

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

Details

• Lead Sponsor: Cedars-Sinai Medical Center
• Collaborator: Astellas Pharma Inc
• Treatments: Mycophenolate mofetil; 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. Calculated PRA (CPRA)> 30% demonstrated on 3 consecutive samples. The methodology to measure PRA includes FLOW and Luminex Single Antigen Assay.

6. At transplant, patient must have an acceptable crossmatch (as defined as T-or B- FCMX ≤ 225 MCS) from non-HLA identical donor. Negative crossmatch is Tpronase FCMX <70; T- FCMX <50 and Bpronase FCMX <130; B-FCMX <100.

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 drugs or to drugs of similar chemical classes

3. Patients being treated with drugs that are strong inducers or inhibitors of cytochrome P450 3A4

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

5. Patients who have any 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, might significantly alter the absorption, distribution, metabolism and/or excretion of study medication

6. 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.

7. Patients who are PCR positive for Hep B, Hep C, or HIV.