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Clinical Trial Details

Trial ID: L0831
Source ID: NCT03194321
Associated Drug: Tacrolimus Extended-Release Oral Capsule
Title: Trial to Evaluate Safety and Tolerability of Tacrolimus Extended-Release (Astagraf XL) in Human Leukocyte Antigen (HLA) Sensitized Kidney Transplant Recipients
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT03194321/results
Conditions: End Stage Renal Disease
Interventions: DRUG: Tacrolimus Extended-Release Oral Capsule
Outcome Measures: Primary: Number of Participants With Treatment-related Adverse Events and Treatment Failure, To determine the safety of tacrolimus extended-release in HS kidney transplant recipients after desensitization with intravenous immunoglobulin (IVIG) and rituximab +/- plasma exchange (PLEX) per the standard of care and alemtuzumab induction. This will be measured by the rate of serious adverse events (SAEs) and treatment failure. Treatment failure is defined as a composite of biopsy proven acute rejection (BPAR), graft failure, or death. BPAR is defined as ≥ Banff 1A using the Banff 2007 criteria., 12 months | Secondary: Change in Donor Specific Antibodies (DSA) as Defined by the DSA Relative Intensity Score (RIS), To observe the change in DSA as defined by the DSA RIS, which is defined by: 0 points for no DSA, 2 points for each weak DSA (MFI \<5,000), 5 points for each moderate DSA (MFI 5,000 -10,000), and 10 points for each strong DSA (MFI \>10,000)., Transplant, 1 month, 3 months, 6 months, 9 months, and 12 months|Tolerability as Defined by the Number of Subjects Discontinuing the Study Medication, To observe the tolerability as defined by the number of subjects discontinuing the study medication., 12 months
Sponsor/Collaborators: Sponsor: Cedars-Sinai Medical Center | Collaborators: Astellas Pharma Inc
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 20
Study Type: INTERVENTIONAL
Study Designs: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2017-09-11
Completion Date: 2020-10-27
Results First Posted: 2021-12-30
Last Update Posted: 2022-01-19
Locations: Cedars Sinai Medical Center, Los Angeles, California, 90048, United States
URL: https://clinicaltrials.gov/show/NCT03194321