Phase 4
N=20
Trial to Evaluate Safety and Tolerability of Tacrolimus Extended-Release (Astagraf XL) in Human Leukocyte Antigen (HLA) Sensitized Kidney Transplant Recipients
End Stage Renal Disease
Bottom Line
View on ClinicalTrials.gov: NCT03194321 ↗Enrolled (actual)
20
Serious AEs
15.0%
Results posted
Dec 2021
Primary outcome: Primary: Number of Participants With Treatment-related Adverse Events and Treatment Failure — 2; 2; 1; 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Tacrolimus Extended-Release Oral Capsule (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Cedars-Sinai Medical Center
- Primary completion
- Oct 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-related Adverse Events and Treatment Failure |
2; 2; 1; 1; 4 | — |
| SECONDARY Change in Donor Specific Antibodies (DSA) as Defined by the DSA Relative Intensity Score (RIS) |
3.21; 0.79; 0.64; 0.93; 0.86; 1.14 | — |
| SECONDARY Tolerability as Defined by the Number of Subjects Discontinuing the Study Medication |
3 | — |
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 (also known as ritux) +/- plasma exchange (PLEX) per the standard of care with alemtuzumab induction.
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
- Calculated Panel Reactive Antibodies (CPRA)> 30% demonstrated on 3 consecutive samples. The methodology to measure polymerase chain reaction (PCR) includes FLOW and Luminex Single Antigen Assay.
- At transplant, patient must have an acceptable crossmatch (as defined as T-or B- Flow Cytometry Crossmatch (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
- Recipients of a dual simultaneous kidney/liver, kidney/heart, kidney/lung, or kidney/pancreas transplant
- History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes
- Patients being treated with drugs that are strong inducers or inhibitors of cytochrome P450 3A4
- Patients with a clinically significant systemic infection within 30 days prior to transplant
- 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
- 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 PCR positive for Hep B, Hep C, or HIV.
Data sourced from ClinicalTrials.gov (NCT03194321). 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.