Status:
COMPLETED
Antibody Response to Human Papillomavirus Recombinant Vaccine (Gardasil®) in Girls and Young Women With Chronic Kidney Disease
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Chronic Kidney Disease
Eligibility:
FEMALE
9-21 years
Phase:
NA
Brief Summary
People with chronic kidney disease are known to have immune response abnormalities, including a diminished response to some vaccinations. Those with chronic kidney disease have a disproportionate burd...
Eligibility Criteria
Inclusion
- Females, aged 9-21 years, in the following groups:
- CKD (defined as estimated glomerular filtration rate between 90 ml/min/1.73m2 and 15 ml/min/1.73m2, as calculated by the Schwartz formula)
- ESRD (eGFR \< 15 ml/min/1.73m2, or receiving chronic dialysis \[peritoneal or hemodialysis\])
- Status-post kidney transplant
Exclusion
- Within first 3 months post kidney transplant
- Within 3 months of kidney rejection episode
- Hypersensitivity to active substances or excipients of Gardasil vaccine
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
67 Patients enrolled
Trial Details
Trial ID
NCT00806676
Start Date
December 1 2008
End Date
August 1 2015
Last Update
July 24 2017
Active Locations (2)
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1
Emory Healthcare & Children's Healthcare of Atlanta Pediatric Nephrology Clinic
Atlanta, Georgia, United States, 30322
2
Johns Hopkins University Harriet Lane Kidney Center, Rubenstein Child Health Bldg
Baltimore, Maryland, United States, 21287