Objectives: The aims of this study were to evaluate the pharmacokinetics (PK) of gadopiclenol, a new macrocyclic gadolinium based-contrast agent, in subjects with impaired renal function, and to assess its dialysability in subjects with end-stage renal disease (ESRD). Methods and Materials: This 2-center, open-label, phase 1 study included 5 successive cohorts of 8 adult subjects: healthy subjects (cohort 1), subjects with mild (cohort 2), moderate (cohort 3), severe (cohort 4) renal impairment, or ESRD (cohort 5), who received a single intravenous injection of gadopiclenol (0.1 mmol/kg). Blood and urine samples were collected at different time points in cohorts 1 to 4, and blood and dialysate samples were collected at each hemodialysis session (4-hour session on day 1, day 3, and day 5) in cohort 5. Gadopiclenol elimination and safety were assessed for up to 6 months. Pharmacokinetics parameters were calculated using noncompartmental analysis. Results: A total of 40 subjects were included, with a mean age of 51.5 years (range, 18-71 years). No significant difference in the mean maximum concentration values and the distribution volume was observed among cohorts 1 to 4. Urinary excretion of unchanged gadopiclenol was delayed with the degree of renal impairment and ranged between 96% and 84% in subjects with mild to severe renal impairment. Compared with that of healthy subjects, the mean area under the plasma concentration curve was 54%, 148%, and 769% higher in subjects with mild, moderate, or severe renal impairment, respectively. The mean terminal half-life was prolonged with the degree of renal impairment (1.9, 3.3, 3.8, and 11.7 hours for cohorts 1-4). In ESRD subjects, gadopiclenol was effectively removed from the plasma (95% to 98%) after the first hemodialysis session. Gadopiclenol concentration in plasma was below the limit of quantification for all subjects after the second hemodialysis session. Gadopiclenol concentration was below limit of quantification in all plasma and urine samples collected at 1, 3, and 6 months. Five subjects (12.5%) experienced adverse events related to gadopiclenol, none serious and all resolved. Laboratory measurements, vital signs, and electrocardiography did not raise any safety concern. Conclusions: Gadopiclenol elimination half-life was prolonged in subjects with mild to severe renal impairment, yet its renal clearance remains complete or nearly complete. In ESRD subjects, gadopiclenol was effectively removed from the plasma after 1 hemodialysis session, and up to 3 hemodialysis sessions were sufficient to completely clear it. No safety concern was raised. Therefore, no dose adjustment seems necessary in this patient population.

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SARS-CoV-2 virus affects all organs and systems of the human body, including urinary and reproductive. Covid-19 disease has symptoms, clinical evolution and unknown complications till our days. Based on urology-specific systematic literature review, the authors describe the epidemiology and mechanisms of male urinary and reproductive system damaged by SARS-CoV-2 virus. The pathogenesis of renal impairment in Covid-19 is multifactorial with direct action of the virus on the nephron, but especially due to factors generated by inflammatory process, intravascular coagulation, hypovolemia, cytokine storm or toxic drug action. The presence of kidney disease until infection with SARSCoV2 virus can be interpreted as a risk factor for the evolution of the disease. Covid-19 disease also has an impact on male sexual-reproductive function, due to erectile dysfunction, decreased sperm motility or hormonal influences. At the moment, there is no evidence about presence of the specific effective drug for the treatment of Covid-19, the only medical solution to avoid side effects of the disease, is and remains vaccination.

The efficacy of various diagnostic imaging methods in determining the morphofunctional features of the affected kidney, the characteristics of kidney stones and its complications, as well as the sensitivity and specificity of conventional imaging methods (ultrasonography, simple KUB radiography, intravenous urography), functional (isotopic renography and dynamic renal scintigraphy) and complex (computed tomography and densitometric tomography associated with infrared spectroscopy) were assessed. Comparison of imaging data with the results of macroscopic evaluation of affected kidneys by stones during surgery allowed to specify the diagnostic contribution of each method with determining its influence on the selection of any applied treatment method. The article assesses an analysis of the main aspects related to diagnosis, the selection criteria for medical-surgical treatment, but especially the surgical techniques, selected from case to case, individualized with the introduction and implementation of numerous diagnostic procedures, treatments, prophylaxis, and metaphylaxis, during the years 2010–2021. The current study of kidney stone disease is complex scientific research, with a multilateral character, which is determined by the multitude of the examined aspects.