Cidofovir in Renal Transplant Recipients With BKVN
Status:
Terminated
Trial end date:
2011-04-01
Target enrollment:
Participant gender:
Summary
This study will look at the safety, tolerability and effectiveness of cidofovir in kidney
transplant patients who have been diagnosed with BK virus nephropathy (BKVN), a viral
condition that can cause patients to reject transplanted kidneys. Up to 48 adult (age 18
years and older) kidney or pancreas transplant recipients with newly diagnosed BKVN will
receive 1 of 3 cidofovir dose levels or placebo (non medicated substance) to identify the
maximum tolerated dose. Dosing will be administered intravenously (by a tube running into a
blood vessel). In addition to the screening visit, volunteers will actively participate for
approximately 8-10 weeks with a single follow up phone call at 4 months. Blood samples, urine
samples, eye exams and physical exams are included in study procedures.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)