| Trial ID: | L1039 |
| Source ID: | NCT02878616
|
| Associated Drug: |
Lfg316
|
| Title: |
Study in End-stage Renal Disease Patients Awaiting Kidney Transplant to Investigate the Potential Effect of IVIG Treatment on the Pharmacokinetics and Pharmacodynamics of LFG316
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Kidney Transplantation
|
| Interventions: |
DRUG: LFG316|DRUG: IVIG
|
| Outcome Measures: |
Primary: Plasma Pharmacokinetics (PK) of LFG316: Area Under the Plasma Concentration-time Curve (AUC), The following PK parameters were determined from the plasma concentration time profile of LFG316 using a non-compartmental method: AUClast: Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration AUCinf: Area under the plasma concentration-time curve from time zero to infinity, 1 month|Plasma Pharmacokinetics (PK) of LFG316: Observed Maximum Plasma Concentration Following Drug Administration (Cmax), 1 month | Secondary: Number of patients with adverse events as a measure of safety and tolerability, 2 months
|
| Sponsor/Collaborators: |
Sponsor: Novartis Pharmaceuticals
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
8
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2016-08-26
|
| Completion Date: |
2017-07-19
|
| Results First Posted: |
|
| Last Update Posted: |
2020-12-11
|
| Locations: |
Novartis Investigative Site, Los Angeles, California, 90048, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT02878616
|
