This first in human study aims at evaluating LIS1, a stabilized solution of purified anti-T lymphocytes polyclonal glyco-humanized swine IgG with immunosuppressive activity, in regards of safety, T cell depletion, and pharmacokinetics / pharmacodynamics in 10 kidney transplant recipients.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
10
LIS1 is an induction treatment on top of maintenance immunosuppressive regimen. All patients from AD and TD cohort will receive the conventional immunosuppressive regimen: tacrolimus (0.2 mg/kg) / mycophenolic acid (MMF, 2x1000 mg) / prednisone (20 mg from day 2). This conventional treatment should be started and monitored for all patients independently of their participation in the clinical trial. Methylprednisolone 500 mg / 100 mL saline / 30 minutes will be administered before reperfusion during the surgery and on post operation day 1 just before LIS1 administration.
Institut klinické a experimentální medicíny
Prague, Czechia
Safety of the treatment with LIS1: Blood pressure
Clinical safety parameters (1): Systolic and diastolic blood pressure (mm Hg).
Time frame: up to 3 months after the transplant
Safety of the treatment with LIS1: Pulse rate
Clinical safety parameters (2): Pulse rate (beats per minute \[bpm\]) .
Time frame: up to 3 months after the transplant
Safety of the treatment with LIS1: Body temperature
Clinical safety parameters (3): Body temperature (Celsius degrees).
Time frame: up to 3 months after the transplant
Safety of the treatment with LIS1: Graft rejection
Clinical safety parameters (4): Graft rejection (yes/no).
Time frame: up to 3 months after the transplant
Safety of the treatment with LIS1: Infection
Clinical safety parameters (5): Viral infections (namely Cytomegalovirus \[CMV\], BK virus) (yes/no).
Time frame: up to 3 months after the transplant
Safety of the treatment with LIS1: Re-admission
Clinical safety parameters (6): Re-admission after patient discharge (yes/no).
Time frame: up to 3 months after the transplant
Safety of the treatment with LIS1: Hospitalization
Clinical safety parameters (7): Prolonged stay in hospital for \>4 weeks (days).
Time frame: up to 3 months after the transplant
Safety of the treatment with LIS1: CRP
Laboratory parameters (1): C-Reactive Protein (CRP, mg/L).
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Time frame: up to 3 months after the transplant
Safety of the treatment with LIS1: LDH
Laboratory parameters (2): Lactate Dehydrogenase (LDH, µkat/L).
Time frame: up to 3 months after the transplant
Safety of the treatment with LIS1: aPTT
Laboratory parameters (3): activated Partial Thromboplastin Time (aPTT, seconds).
Time frame: up to 3 months after the transplant
Safety of the treatment with LIS1: Complete Blood Count (CBC)
Laboratory parameters (4): Platelets (10\^9/L), white blood cells (10\^9/L), absolute neutrophil count (10\^9/L), absolute lymphocyte count (10\^9/L), absolute monocyte count (10\^9/L), absolute eosinophil count (10\^9/L), absolute basophil count (10\^9/L).
Time frame: up to 3 months after the transplant
Pharmacodynamics (depletion of T lymphocytes) of LIS1
Absolute T lymphocyte counts (10\^9/L).
Time frame: up to 3 months after the transplant
Pharmacokinetics of LIS1 (1): swine IgG
Serum concentration of swine IgG
Time frame: up to 3 months after the transplant
Pharmacodynamics of LIS1 (2): cytokines
Cytokine concentration (IL6, TNFα) (ng/mL).
Time frame: up to 3 months after the transplant
Biology of LIS1 (1): electrolytes plasma concentration
Plasma biochemistry: electrolytes (Na+, K+, Cl-, Ca++, Mg++, bicarbonates plasma concentrations mmol/L)
Time frame: up to 3 months after the transplant
Biology of LIS1 (2): urea and creatinine
Plasma biochemistry: urea and creatinine plasma concentration (mmol/L)
Time frame: up to 3 months after the transplant
Biology of LIS1 (3): total plasma proteins
Plasma biochemistry: Total protein plasma concentration (g/L)
Time frame: up to 3 months after the transplant
Biology of LIS1 (4): plasmatic proteins
Plasma biochemistry: electrophoresis of plasmatic proteins (percentages of albumin, alpha-1-globulin, alpha-2-globulin, beta-globulin, gamma-globulin)
Time frame: up to 3 months after the transplant
Immunogenicity of LIS1
Detection of antidrug antibodies in serum
Time frame: up to 3 months after the transplant