| Trial ID: | L1152 |
| Source ID: | NCT03213158
|
| Associated Drug: |
Ixazomib Oral Capsule
|
| Title: |
Ixazomib for Desensitization
|
| Acronym: |
IXADES
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT03213158/results
|
| Conditions: |
Kidney Diseases|End Stage Renal Disease
|
| Interventions: |
DRUG: Ixazomib Oral Capsule
|
| Outcome Measures: |
Primary: Efficacy of Ixazomib: Percentage of Participants With > 20 Percent Decline in Calculated Panel Reactive Antibody (cPRA), up to 12 months|Efficacy of Ixazomib: Percentage of Participants Received Successful Kidney Transplantation Within 12 Months, up to 12 months | Secondary: Safety of Ixazomib as Assesses by Percentage of Participants With Cardiovascular Complications Within 12 Months, up to 12 months|Safety of Ixazomib as Assesses by Percentage of Participants With Hematological Complications Within 12 Months, Hematological complications include leucopenia, anemia, and thrombocytopenia, up to 12 months|Safety of Ixazomib as Assesses by Percentage of Participants With Malignancies Within 12 Months, up to 12 months|Safety of Ixazomib as Assesses by Percentage of Participants With Gastrointestinal Symptoms Within 12 Months, up to 12 months|Safety of Ixazomib as Assesses by Percentage of Participants Caught Infection Within 12 Months, up to 12 months|Safety of Ixazomib as Assesses by Percentage of Participants With Thrombocytopenia Within 12 Months, up to 12 months|Safety of Ixazomib: as Assesses by Percentage of Participants With Distal Neuropathy Within 12 Months, up to 12 months | Other: Change in Circulating BAFF Levels as Assessed by BAFF ELISA Assay, B cell activating factor belonging to the TNF family (BAFF) are members of the TNF ligand superfamily. Plasma BAFF ELISA assays can be performed in 2-3 hours. It can be used as a marker of disease activity in sensitized patients., Baseline, 3 months|Change in Circulating APRIL Levels as Assessed by APRIL ELISA Assay, B cell activating factor belonging to a proliferation-inducing ligand (APRIL) are members of the TNF ligand superfamily. Plasma APRIL ELISA assay can be performed in 2-3 hours. It can be used as a marker of disease activity in sensitized patients., Baseline, 3 months
|
| Sponsor/Collaborators: |
Sponsor: University of Wisconsin, Madison | Collaborators: Millennium Pharmaceuticals, Inc.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
10
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2017-09-15
|
| Completion Date: |
2021-04-16
|
| Results First Posted: |
2022-05-11
|
| Last Update Posted: |
2022-06-01
|
| Locations: |
University of Wisconsin Hospital and Clinics, Madison, Wisconsin, 53792, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT03213158
|
