The objective of this study is to determine the doses of VPA-985, a selective non-peptide antagonist of vasopressin-2 receptors, that safely and efficaciously increase serum sodium in patients with hyponatremia of diverse etiologies. Secondary objectives are to compare efficacy in an outpatient and inpatient setting and to determine if correction of the hyponatremia improves cognitive function or other measures of clinical benefit. The design is a randomized, double-blind, parallel group, placebo controlled, multi-center, inpatient and outpatient study. The subjects will be patients, age 18-80, with chronic hyponatremia due to liver failure or SIADH. After pre-study screening, they will be admitted to the GCRC and randomly assigned to receive placebo or one of three doses of the VPA-985 twice daily for seven days. Fluid intake will be restricted and serum sodium, body weight, urine output, vital signs and physical condition will be determined daily. Vasopressin and other hormones will be measured before and after the treatment. If clinically indicated, the patient will be discharged on the same treatment and followed in the outpatient clinic for two weeks. The treatment then will be stopped and the final post-treatment examination given. Cognitive function tests will be performed before and after the inpatient and outpatient phase. All tests except plasma sodium will be performed or scored by a central laboratory, and the results will be analyzed by Wyeth-Ayerst.
| Sherenian, Michael G; Singh, Anne M; Arguelles, Lester et al. (2018) Association of food allergy and decreased lung function in children and young adults with asthma. Ann Allergy Asthma Immunol 121:588-593.e1 |
| Baron, Kelly Glazer; Reid, Kathryn J; Malkani, Roneil G et al. (2017) Sleep Variability Among Older Adults With Insomnia: Associations With Sleep Quality and Cardiometabolic Disease Risk. Behav Sleep Med 15:144-157 |
| Makhija, Melanie M; Robison, Rachel G; Caruso, Deanna et al. (2016) Patterns of allergen sensitization and self-reported allergic disease in parents of food allergic children. Ann Allergy Asthma Immunol 117:382-386.e1 |
| Gupta, Ruchi S; Walkner, Madeline M; Greenhawt, Matthew et al. (2016) Food Allergy Sensitization and Presentation in Siblings of Food Allergic Children. J Allergy Clin Immunol Pract 4:956-62 |
| Raghanti, Mary Ann; Edler, Melissa K; Stephenson, Alexa R et al. (2016) Human-specific increase of dopaminergic innervation in a striatal region associated with speech and language: A comparative analysis of the primate basal ganglia. J Comp Neurol 524:2117-29 |
| Slama, Laurence; Jacobson, Lisa P; Li, Xiuhong et al. (2016) Longitudinal Changes Over 10 Years in Free Testosterone Among HIV-Infected and HIV-Uninfected Men. J Acquir Immune Defic Syndr 71:57-64 |
| Ye, Wen; Rosenthal, Philip; Magee, John C et al. (2015) Factors Determining ?-Bilirubin Levels in Infants With Biliary Atresia. J Pediatr Gastroenterol Nutr 60:659-63 |
| Arroyo-Ávila, Mariangelí; Santiago-Casas, Yesenia; McGwin Jr, Gerald et al. (2015) Clinical associations of anti-Smith antibodies in PROFILE: a multi-ethnic lupus cohort. Clin Rheumatol 34:1217-23 |
| Lertratanakul, Apinya; Wu, Peggy; Dyer, Alan R et al. (2014) Risk factors in the progression of subclinical atherosclerosis in women with systemic lupus erythematosus. Arthritis Care Res (Hoboken) 66:1177-85 |
| Nodzenski, Michael; Muehlbauer, Michael J; Bain, James R et al. (2014) Metabomxtr: an R package for mixture-model analysis of non-targeted metabolomics data. Bioinformatics 30:3287-8 |
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