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Chronic Kidney FailureNCT00153621

Prevalence of Proteinuria and Chronic Kidney Disease in Pediatric HIV-Infected Patients

An observational study of Chronic Kidney Failure and AIDS-Associated Nephropathy, run by Children's National Research Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Among adults with Human Immunodeficiency Virus (HIV) and Acquired Immunodeficiency Syndrome (AIDS), Chronic Kidney Disease (CKD) has previously been reported to occur in approximately 10% of children with HIV-infection. Read more about this study

Who is it for?
Ages 1 year to 21 years
How many people
320 participants
Where
1 siteUnited States
Study dates
Sep 2004to Sep 2007
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 1 year to 21 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Known/confirmed HIV-infection or AIDS
  • Age > 1 but < 21 years of age
  • Able to tolerate discontinuation of ACEI or ARB
  • Either gender

Who cannot join

  • HIV negative status
  • Age < 1 or > 21 years of age
  • Unable to tolerate discontinuation of ACEI or ARB

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Children's National Medical Center

    Washington D.C., District of Columbia, 20010

Other trials in United States

About this study

Official title: Prevalence of Proteinuria and Chronic Kidney Disease in Pediatric Patients in the Special Immunology, Burgess, and Nephrology Clinics

Among adults with Human Immunodeficiency Virus (HIV) and Acquired Immunodeficiency Syndrome (AIDS), Chronic Kidney Disease (CKD) has previously been reported to occur in approximately 10% of children with HIV-infection. The frequency of CKD, its causes, and its natural history in children and adolescents with HIV-infection have not been systematically studied, particularly in the era of new anti-retroviral medications. The primary aim of this study is to determine the how common pediatric HIV-infected individuals have evidence of persistent proteinuria and CKD.

Read the detailed description

Human Immunodeficiency Virus-infection has been a significant cause of pediatric morbidity and mortality since it was first identified in the early 1980s. In 1997, HIV became the fourth leading cause of death among children 1 to 4 years of age. As of December 2001, there were 9,074 children under the age of 13 years who have been diagnosed with AIDS in the United States and its territories, and an additional 3,923 children with HIV-infection under the age of 13 years. Human Immunodeficiency Virus-infection and AIDS do not affect children equally in the United States. Whereas whites comprise 61% of the pediatric population, they represent only 15-20% of children with HIV or AIDS. In contrast, African-Americans account for only 14% of the US pediatric population, but they represent 60-65% of children with HIV or AIDS. The prevalence rate of AIDS among African-American children in 2001 was 14 times greater than among white children, and 7 times higher than among Hispanic children.

A variety of renal, electrolyte, and acid-base disturbances have been described in patients with HIV-infection. These abnormalities may be associated with the HIV-infection itself, opportunistic infections, antiviral medications, or unrelated primary disorders. Proteinuria may serve as an early indicator of HIV-associated nephropathy (HIVAN), the pathologic renal lesions associated with HIV-infection itself. Autopsy data in adults with HIV-infection or AIDS have demonstrated a prevalence of HIVAN of between 1 and 15%. The prevalence of HIVAN in the pediatric population has been reported between 7 and 15%. The racial disparity seen in the AIDS population has also been described in the pediatric HIVAN population. Reports of HIVAN in pediatric populations found that 137 of 155 children (89%) in Miami, Florida and 208 of 217 children (96%) in Washington, DC were African-American.

The medical progress made in the treatment of HIV infection with highly active antiretroviral therapies (HAART) has led to a dramatic decline in the incidence of death among adults with HIV-infection. By 1999, however, HIV became the third leading cause of end-stage renal disease (ESRD) among African-Americans aged 20 to 64 years. In contrast to the declining incidence of HIV-infection in the adult population, the incidence of ESRD due to HIVAN has decreased much slower for unknown reasons. The incidence of pediatric AIDS cases also has been declining over the past decade, from 952 new cases diagnosed in 1992 to only 101 in 2001. The impact of the declining incidence of pediatric AIDS cases upon the incidence of pediatric HIVAN remains unknown. The progression of pediatric HIVAN appears to occur more slowly than the adult HIVAN population, with a mean time from initial diagnosis of HIVAN to ESRD of 8 to 20 months. Mortality is high in the pediatric HIV-infected population, with nearly 80% of pediatric patients with HIVAN dying.

For this study, we seek to estimate the prevalence of CKD in HIV-infected patients overall and within specific racial groups.

Participants will be screened with a first-morning macroscopic urinalysis for the detection of proteinuria, and a semi-quantitative measurement of proteinuria using urine protein-to-creatinine and urine microalbumin-to-creatinine ratios. Those patients who have proteinuria of greater than or equal to 1+ on a first-morning macrourinalysis, or a urine protein-to-creatinine ratio of > 0.20 or a urine microalbumin-to-creatinine ratio of > 30 mcg/mg of creatinine, will have a repeat first-morning macroscopic urinalysis, and urine protein-to-creatinine and urine microalbumin-to-creatinine ratios performed 3 months later. Prior to the obtaining of any of the urine samples, those participants who are taking angiotensin converting enzyme inhibitors (ACEI) or angiotensin receptor blockers (ARB) therapy for their anti-proteinuric or anti-hypertensive effects will discontinue their medication for 2 weeks prior to the urine sample collection. After collecting the first-morning urine sample, the study participant may resume his/her prior ACEI or ARB at the previously prescribed dose and schedule. Those patients who have fixed proteinuria on a first-morning macroscopic urinalysis on 2 occasions separated by 3 months will be referred to the Pediatric Nephrology Clinic for further evaluation for proteinuria and/or CKD. The calculated GFR will be determined using the most recent serum creatinine and patient height from the medical record using the Schwartz formula. Chronic Kidney Disease will be defined, as in the NKF KDOQI guidelines.

Keywords
Pediatrics, Chronic Kidney Failure, HIV, Acquired Immunodeficiency Syndrome, AIDS-Associated Nephropathy
Medical subject headings
Kidney Failure, Chronic, AIDS-Associated Nephropathy, HIV Infections, Acquired Immunodeficiency Syndrome

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Sep 2005 (estimated)
  2. Study startSep 2004
  3. Study completionSep 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Time perspective
Prospective
Enrolment
320 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00153621
Sponsor's protocol ID
3406
Other IDs
NCRR 1K12RR017613-01
Status last verified
Sep 2005
First submitted
8 Sep 2005
Last updated
5 May 2008
Results posted
No

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Kidney Failure and AIDS-Associated Nephropathy, run by Children's National Research Institute 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 3 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 5 May 2008. 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 5 May 2008.

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