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Clinical Trials/NCT00767897
NCT00767897
Completed
Not Applicable

The Impact of the Human Papilloma Virus in Pediatric Chronic Kidney Disease, Dialysis, and Transplant Patients

Indiana University1 site in 1 country72 target enrollmentNovember 2011
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ConditionsChronic Kidney DiseaseDialysis
InterventionsHuman Papillomavirus Vaccine
DrugsHuman Papillomavirus Vaccine

Overview

Phase
Not Applicable
Intervention
Human Papillomavirus Vaccine
Conditions
Chronic Kidney Disease
Sponsor
Indiana University
Enrollment
72
Locations
1
Status
Completed
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

Overview

Brief Summary

The proposed study is a pilot study and a first step towards developing an optimized HPV vaccination strategy for girls who have CKD, or are on dialysis or have a kidney transplant.

Registry
clinicaltrials.gov
Start Date
November 2011
End Date
December 2018
Last Updated
2 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Corina Nailescu

Associate Professor of Clinical Pediatrics

Indiana University

Eligibility Criteria

Inclusion Criteria

  • •9-18-year-old girls who have CKD stages 3 or 4 (Glomerular filtration rates 15-59 mL/min/1.73m2).
  • •9-18-year-old girls who are on dialysis.
  • •9-18-year-old girls who have had a functioning kidney transplant for longer than 6 months and are on the same immunosuppression regimen.
  • •Healthy 9-18-year-old girls

Exclusion Criteria

  • •Pregnancy, fever, allergy to any vaccine component, any immune disorder and any blood product received in the previous 6 months.

Arms & Interventions

CKD stage 3 or 4

Girls and Boys age 9-18 with CKD stage 3 or 4

Intervention: Human Papillomavirus Vaccine

On dialysis

Girls and Boys age 9-18 who are on dialysis

Intervention: Human Papillomavirus Vaccine

Transplanted

Girls and Boys age 9-18 who have had a functioning kidney transplant for longer than 6 months and are on the same immunosuppression regimen.

Intervention: Human Papillomavirus Vaccine

Healthy

Girls and Boys age 9-18

Intervention: Human Papillomavirus Vaccine

Outcomes

Primary Outcomes

Not specified

Study Sites (1)

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