This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This study, representing one arm of a multicenter NIH-funded phase I/II trial, seeks to test the hypothesis that a TNFa antagonist (the monoclonal agent adalumimab) and a PPARg agonist (rosiglitazone) can be administered safey to patients with focal segmental glomerulosclerosis (FSGS) who have not responded to conventional therapy. Pharmacokinetic (PK) studies will assess the impact of proteinuria on the dynamics of these drugs in both children and adults. The study will enroll 20 subjects nationwide, including 1-3 patients at CHW. Patients recruited from the Nephrology Divisions of Adult and Pediatric Medicine will be admitted to the GCRC for an initial 44-hr PK evaluation (11 samples drawn). Subjects will participate for ~12 months (total 9 visits), including 4 months on study treatment. GCRC nursing support is requested to assist with the outpatient visits, which include history and physical, iv line placement, and sampling and preparation of samples prior to shipment.
Showing the most recent 10 out of 380 publications
