| Trial ID: | L1143 |
| Source ID: | NCT02475551
|
| Associated Drug: |
Ides
|
| Title: |
Study to Evaluate the Safety, Tolerability, Efficacy and PK of IdeS in Kidney Transplantation
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
End Stage Kidney Disease
|
| Interventions: |
DRUG: IdeS
|
| Outcome Measures: |
Primary: safety, Adverse events, clinical laboratory tests, vital signs and ECGs, 6 months | Secondary: Efficacy (mean fluorescent intensity (MFI) of less than 1100 as measured in an single antigen bead (SAB) assay), Efficacy defined as the IdeS dosing scheme resulting in anti human leucocyte antigen (HLA) antibody levels which are acceptable for transplantation, measured as an mean fluorescent intensity (MFI) of less than 1100 as measured in an single antigen bead (SAB) assay, within 24 hours from dosing, 24 hours
|
| Sponsor/Collaborators: |
Sponsor: Hansa Biopharma AB | Collaborators: Uppsala University Hospital|Karolinska Institutet
|
| 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: |
2015-06
|
| Completion Date: |
2016-10
|
| Results First Posted: |
|
| Last Update Posted: |
2018-01-08
|
| Locations: |
Hansa Medical AB, Lund, 22007, Sweden
|
| URL: |
https://clinicaltrials.gov/show/NCT02475551
|
