| Trial ID: | L1488 |
| Source ID: | NCT03380962
|
| Associated Drug: |
Clazakizumab
|
| Title: |
Clazakizumab in Highly-HLA Sensitized Patients Awaiting Renal Transplant
|
| Acronym: |
|
| Status: |
ACTIVE_NOT_RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Kidney Failure, Chronic|End-Stage Renal Disease|Transplant Glomerulopathy|Transplant;Failure,Kidney|Kidney Transplant Failure and Rejection|Antibody-mediated Rejection|Kidney Transplant; Complications
|
| Interventions: |
DRUG: Clazakizumab
|
| Outcome Measures: |
Primary: Change in donor specific antibodies, Assessment of HLA antibodies from baseline based on luminex assessments at multiple time points, Up to 21 months|Incidence of treatment related adverse effects of clazakizumab therapy, Assessments of any side effects associated with clazakizumab administration and risk for infectious complications associated with clazakizumab therapy for desensitization of HS patients awaiting renal HLAi transplantation, Up to 21 months | Secondary: Change in Serum Creatinine, Assessment of renal function by collecting Serum Creatinine (md/dl) at multiple time points, Up to 21 months|Incidence of ABMR episodes, Assessment of protocol biopsy results, Up to 12 months post-transplant
|
| Sponsor/Collaborators: |
Sponsor: Stanley Jordan, MD
|
| Gender: |
ALL
|
| Age: |
CHILD, ADULT, OLDER_ADULT
|
| Phases: |
PHASE1|PHASE2
|
| Enrollment: |
20
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2018-02-27
|
| Completion Date: |
2025-08-30
|
| Results First Posted: |
|
| Last Update Posted: |
2025-03-24
|
| Locations: |
Norko Ammerman, Los Angeles, California, 90048, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT03380962
|
