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
NCT ID: NCT02878616
Last Updated: 2020-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
8 participants
INTERVENTIONAL
2016-08-26
2017-07-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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LFG316 + IVIG
LFG316
LFG316 single dose
IVIG
IVIG single dose
LFG316 alone
LFG316
LFG316 single dose
Interventions
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LFG316
LFG316 single dose
IVIG
IVIG single dose
Eligibility Criteria
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Inclusion Criteria
2. Candidates for kidney transplantation who are pre-sensitized and will be undergoing desensitization therapy.
3. Written informed consent must be obtained before any assessment is performed.
4. Able to communicate well with the investigator, to understand and comply with the requirements of the study.
5. Recipients who are ABO compatible with donor allograft.
6. Patients awaiting kidney allograft from a living or deceased donor. For patients awaiting transplant from a living donor, kidney transplantation must only occur after 28 days post-LFG316 infusion.
7. History of vaccination with meningococcus and pneumococcus between 2 weeks and 36 months prior to dosing. Documentation is required. If patients have not been vaccinated, they must be vaccinated at least 2 weeks prior to dosing. The choice of vaccine(s) should take into account the serotypes prevalent in the geographic areas in which study patients will be enrolled.
Exclusion Criteria
2. Patients with a known contraindication to treatment with blood products.
3. Patients with a known pro-thrombotic disorder and/or history of thrombosis or hyper-coagulable state, excluding hemodialysis venous access clotting.
4. Patients who have positive PCR results for hepatitis B and/or hepatitis C, and/or history of immunodeficiency diseases, including a positive HIV (ELISA and Western blot) test result.
5. Patients at risk for tuberculosis (TB)
6. Patients with any severe, progressive or uncontrolled acute or chronic medical condition not related to end-stage renal disease (such as uncontrolled infectious disease or sepsis), clinical laboratory abnormalities at screening or baseline that in the investigator's opinion would make the patient inappropriate for entry into this study, or known active presence of malignancies.
7. Pregnant or nursing (lactating) women.
8. Women of child-bearing potential, unless highly effective methods of contraception are used during dosing and for 50 days after the last dose of LFG316, or sexually active males unwilling to use a condom during intercourse while taking investigational drug and for 50 days after the last dose of LFG316.
18 Years
70 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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Novartis Investigative Site
Los Angeles, California, United States
Countries
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References
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Jordan SC, Kucher K, Bagger M, Hockey HU, Wagner K, Ammerman N, Vo A. Intravenous immunoglobulin significantly reduces exposure of concomitantly administered anti-C5 monoclonal antibody tesidolumab. Am J Transplant. 2020 Sep;20(9):2581-2588. doi: 10.1111/ajt.15922. Epub 2020 May 13.
Related Links
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A Plain Language Trial Summary is available on novartisclinicatrials.com
Results for CLFG316B2101 can be found on Novartisclinicatrials.com
Other Identifiers
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CLFG316B2101
Identifier Type: -
Identifier Source: org_study_id