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



Status:Completed
Conditions:Renal Impairment / Chronic Kidney Disease, Renal Impairment / Chronic Kidney Disease
Therapuetic Areas:Nephrology / Urology
Healthy:No
Age Range:18 - 70
Updated:8/1/2018
Start Date:August 26, 2016
End Date:July 19, 2017

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Open-label, Parallel-group, Drug-drug Interaction 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

Investigate whether concomitant treatment with intravenous immunoglobulin (IVIG) can alter
the pharmacokinetics and pharmacodynamics of LFG316 to an extent which would necessitate dose
adaptation for LFG316 in pre-sensitized end-stage renal disease patients awaiting kidney
transplantation


Inclusion Criteria:

1. Adult men or women 18-70 years of age suffering from end-stage renal disease and who
are on chronic dialysis therapy.

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:

1. Patients requiring or undergoing peritoneal dialysis.

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.

Other protocol-defined inclusion/exclusion criteria may apply.
We found this trial at
1
site
Los Angeles, California 90095
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from
Los Angeles, CA
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