Ignite Creation Date:
2024-05-05 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00153621
Status:
COMPLETED
Last Update Posted:
2008-05-05
First Post:
2005-09-08
Brief Title:
Prevalence of Proteinuria and Chronic Kidney Disease in Pediatric HIV-Infected Patients
Sponsor:
Childrens National Research Institute
Organization:
Childrens National Research Institute
Study Overview
Official Title:
Prevalence of Proteinuria and Chronic Kidney Disease in Pediatric Patients in the Special Immunology Burgess and Nephrology Clinics
Status:
COMPLETED
Status Verified Date:
2005-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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
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 9074 children under the age of 13 years who have been diagnosed with AIDS in the United States and its territories and an additional 3923 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 020 or a urine microalbumin-to-creatinine ratio of 30 mcgmg 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 hisher 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 andor 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
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 020 or a urine microalbumin-to-creatinine ratio of 30 mcgmg 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 hisher 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 andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCRR 1K12RR017613-01 | None | None | None |