Abstract

This study is a randomized, double-blind, placebo-controlled, multicenter, parallel group comparison study designed to evaluate the efficacy of chronic, passive antibody immunotherapy employing one of two doses of a mucoid exopolysaccharide pseudomonas aeruginosa immune globin, intravenous (human) (MEP IGIV) in cystic fibrosis (CF) patients with endobronchial colonization by mucoid pseudomonas aeruginosa. MEP IGIV is selectively enriched for antibodies to the mucoid exopolysaccharide of P.aeruginosa (MEP) which support opsonophagocytic killing of the bacterium. Antibodies are induced by immunization of plasma donors with an MEP immunizing agent. A Phase I clinical trial in CF patients that evaluated the safety and pharmacokinetics of 25, 100, 250 and 500 mg/kg MEP IGIV versus 500 mg/kg of a conventional IGIV has shown single doses of MEP IGIV to be well-tolerated by CF patients, with a half-life permitting a monthly dosing regimen. The goal of this study is to determine the effect in CF patients of monthly dosing of MEP IGIV on the frequency of acute pulmonary exacerbation (the primary clinical and statistical endpoint).

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR000054-35
Application #
5218288
Study Section
Project Start
Project End
Budget Start
Budget End
Support Year
35
Fiscal Year
1996
Total Cost
Indirect Cost

  Publications

Nowak, Kristen L; You, Zhiying; Gitomer, Berenice et al. (2018) Overweight and Obesity Are Predictors of Progression in Early Autosomal Dominant Polycystic Kidney Disease. J Am Soc Nephrol 29:571-578
Lamon-Fava, Stefania; Diffenderfer, Margaret R; Barrett, P Hugh R et al. (2018) Differential Effects of Estrogen and Progestin on Apolipoprotein B100 and B48 Kinetics in Postmenopausal Women. Lipids 53:167-175
Askie, Lisa M; Darlow, Brian A; Finer, Neil et al. (2018) Association Between Oxygen Saturation Targeting and Death or Disability in Extremely Preterm Infants in the Neonatal Oxygenation Prospective Meta-analysis Collaboration. JAMA 319:2190-2201
Dad, Taimur; Abebe, Kaleab Z; Bae, K Ty et al. (2018) Longitudinal Assessment of Left Ventricular Mass in Autosomal Dominant Polycystic Kidney Disease. Kidney Int Rep 3:619-624
Brosnahan, Godela M; Abebe, Kaleab Z; Rahbari-Oskoui, Frederic F et al. (2017) Effect of Statin Therapy on the Progression of Autosomal Dominant Polycystic Kidney Disease. A Secondary Analysis of the HALT PKD Trials. Curr Hypertens Rev 13:109-120
Di Fiore, Juliann M; Martin, Richard J; Li, Hong et al. (2017) Patterns of Oxygenation, Mortality, and Growth Status in the Surfactant Positive Pressure and Oxygen Trial Cohort. J Pediatr 186:49-56.e1
Scherzer, Rebecca; Heymsfield, Steven B; Rimland, David et al. (2017) Association of serum albumin and aspartate transaminase with 5-year all-cause mortality in HIV/hepatitis C virus coinfection and HIV monoinfection. AIDS 31:71-79
Torres, Vicente E; Abebe, Kaleab Z; Schrier, Robert W et al. (2017) Dietary salt restriction is beneficial to the management of autosomal dominant polycystic kidney disease. Kidney Int 91:493-500
Younge, Noelle; Goldstein, Ricki F; Bann, Carla M et al. (2017) Survival and Neurodevelopmental Outcomes among Periviable Infants. N Engl J Med 376:617-628
Irazabal, María V; Abebe, Kaleab Z; Bae, Kyongtae Ty et al. (2017) Prognostic enrichment design in clinical trials for autosomal dominant polycystic kidney disease: the HALT-PKD clinical trial. Nephrol Dial Transplant 32:1857-1865

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