Chronic Kidney DiseaseNCT00767897
The Impact of the Human Papilloma Virus in Pediatric Chronic Kidney Disease, Dialysis, and Transplant Patients
An observational study of Chronic Kidney Disease and Dialysis, run by Indiana University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 9 to 18 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Disease, Dialysis
- What is being tested?
- Human Papillomavirus Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 18 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: Girls age 9-18 who are healthy, have chronic kidney disease stage 3 or 4, are on dialysis, or have had a functioning kidney transplant for longer than 6 months and are on the same immunosuppression regimen.
Who may be able to join
- 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
Who cannot join
- Pregnancy, fever, allergy to any vaccine component, any immune disorder and any blood product received in the previous 6 months.
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University/Riley Children's Hospital
Indianapolis, Indiana, 46202
About this study
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.
- Conditions
- Chronic Kidney Disease, Dialysis
- Being tested
- Human Papillomavirus Vaccine
- Keywords
- Dose response relationship, immunity
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human Papillomavirus VaccineDrug
The HPV vaccination will be administered by intramuscular injection in three separate 0.5mL doses. The recommended schedule is a 3-dose series with dose #2 and #3 administered 2 and 6 months after dose #1, respectively. The minimum interval between dose #1 and #2 of the vaccine is 4 weeks. The minimum recommended interval between dose #2 and #3 of the vaccine is 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| CKD stage 3 or 4 | Girls and Boys age 9-18 with CKD stage 3 or 4 Receives: Drug: Human Papillomavirus Vaccine | |
| On dialysis | Girls and Boys age 9-18 who are on dialysis Receives: Drug: 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. Receives: Drug: Human Papillomavirus Vaccine | |
| Healthy | Girls and Boys age 9-18 Receives: Drug: Human Papillomavirus Vaccine |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2008 (estimated)
- Study startNov 2011
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, National Kidney Foundation, United States
- Responsible party
- Principal investigator, Corina Nailescu, Indiana University
- Investigators
- Corina Nailescu, M.D., Principal investigator, Indiana University/Riley Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00767897
- Sponsor's protocol ID
- 0807-02
- Status last verified
- Mar 2024
- First submitted
- 6 Oct 2008
- Last updated
- 29 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of the Human Papilloma Virus in Pediatric Chronic Kidney Disease, Dialysis, and Transplant Patients
- ClinicalTrials.gov ID
- NCT00767897
- Acronym / sponsor ID
- 0807-02
- Conditions
- Chronic Kidney Disease, Dialysis
- Keywords
- Dose response relationship, immunity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, National Kidney Foundation, United States
- Study start
- Nov 2011
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 7 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CKD stage 3 or 4 | – | Drug: Human Papillomavirus VaccineGirls and Boys age 9-18 with CKD stage 3 or 4 |
| On dialysis | – | Drug: Human Papillomavirus VaccineGirls and Boys age 9-18 who are on dialysis |
| Transplanted | – | Drug: Human Papillomavirus VaccineGirls and Boys age 9-18 who have had a functioning kidney transplant for longer than 6 months and are on the same immunosuppression regimen. |
| Healthy | – | Drug: Human Papillomavirus VaccineGirls and Boys age 9-18 |
Who may qualify
- Ages
- 9 to 18 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Girls age 9-18 who are healthy, have chronic kidney disease stage 3 or 4, are on dialysis, or have had a functioning kidney transplant for longer than 6 months and are on the same immunosuppression regimen.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Pregnancy, fever, allergy to any vaccine component, any immune disorder and any blood product received in the previous 6 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Human Papillomavirus VaccineThe HPV vaccination will be administered by intramuscular injection in three separate 0.5mL doses. The recommended schedule is a 3-dose series with dose #2 and #3 administered 2 and 6 months after dose #1, respectively. The minimum interval between dose #1 and #2 of the vaccine is 4 weeks. The minimum recommended interval between dose #2 and #3 of the vaccine is 12 weeks. | Drug | CKD stage 3 or 4, Healthy, On dialysis, Transplanted |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Corina Nailescu, M.D. principal investigator
Indiana University/Riley Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Disease and Dialysis, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2024.