Status:

COMPLETED

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

Lead Sponsor:

Indiana University

Collaborating Sponsors:

Merck Sharp & Dohme LLC

National Kidney Foundation, United States

Conditions:

Chronic Kidney Disease

Dialysis

Eligibility:

FEMALE

9-18 years

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.

Eligibility Criteria

Inclusion

  • 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

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

Key Trial Info

Start Date :

November 1 2011

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

December 1 2018

Estimated Enrollment :

72 Patients enrolled

Trial Details

Trial ID

NCT00767897

Start Date

November 1 2011

End Date

December 1 2018

Last Update

March 29 2024

Active Locations (1)

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Indiana University/Riley Children's Hospital

Indianapolis, Indiana, United States, 46202