Ignite Creation Date:
2024-05-05 @ 6:38 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00524992
Status:
COMPLETED
Last Update Posted:
2018-04-05
First Post:
2007-09-01
Brief Title:
Evaluation of Albuminuria HIV-Infected Patients
Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Prospective Evaluation of Albuminuria in HIV Positive Patients
Status:
COMPLETED
Status Verified Date:
2014-12-24
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:
This study will examine the following 1 how common albuminuria and proteinuria are among HIV-positive patients 2 what causes albuminuria or proteinuria in these patients and 3 whether the condition becomes more severe over time HIV-infected people are more likely than others to develop kidney disease The earliest indicator of the possible presence of kidney disease is albuminuria increased amounts of the protein albumin in the urine A later indicator is the appearance of other proteins a condition called proteinuria
HIV-infected patients 8 years of age and older who do not have diabetes chronic kidney disease or cancer may be eligible for this study
Participants provide a urine sample during three visits as follows the first upon enrollment in the study a second 3 months later and a third about 6 months after that Blood samples are drawn at the first and last visits At the first visit a medical history is taken and blood pressure height weight waist circumference hip circumference and upper arm skin thickness are measured
Participants who are found to have albuminuria or proteinuria are asked to undergo a kidney biopsy for research purposes The procedure is optional Participants who develop heavy proteinuria may be recommended to undergo a kidney biopsy in order to determine the nature of the kidney disease and begin treatment The biopsy requires a 2-day hospital stay For the procedure an anesthetic is given to numb the skin and a needle is inserted and guided into the kidney to withdraw a small tissue sample The needle is passed twice and possibly three times Following the procedure the subject remains in bed rest for at least 10 hours to minimize the risk of excessive bleeding
HIV-infected patients 8 years of age and older who do not have diabetes chronic kidney disease or cancer may be eligible for this study
Participants provide a urine sample during three visits as follows the first upon enrollment in the study a second 3 months later and a third about 6 months after that Blood samples are drawn at the first and last visits At the first visit a medical history is taken and blood pressure height weight waist circumference hip circumference and upper arm skin thickness are measured
Participants who are found to have albuminuria or proteinuria are asked to undergo a kidney biopsy for research purposes The procedure is optional Participants who develop heavy proteinuria may be recommended to undergo a kidney biopsy in order to determine the nature of the kidney disease and begin treatment The biopsy requires a 2-day hospital stay For the procedure an anesthetic is given to numb the skin and a needle is inserted and guided into the kidney to withdraw a small tissue sample The needle is passed twice and possibly three times Following the procedure the subject remains in bed rest for at least 10 hours to minimize the risk of excessive bleeding
Detailed Description:
Problem The appropriate approach to screening patients for early HIV-associated kidney disease is unknown Recently screening for microalbuminuria has been proposed the clinical implications of finding microalbuminuria in this population are unknown as several disease processes may contribute to microalbuminuria in this setting
Background Renal disease is becoming more common as patients with HIV disease live longer Renal diseases in this population include glomerular diseases collapsing glomerulopathy immune complex glomerulonephritis diabetic nephropathy and hypertensive glomerulosclerosis and various tubular diseases Systemic endothelial dysfunction occurring as part of metabolic syndrome and related disorders such as hypertension hyperlipidemia and insulin resistance is also associated with microalbuminuria
Study Objective We wish to determine whether screening for microalbuminuria will detect early stage glomerular disease We also wish to determine whether in some subjects renal histology is normal and microalbuminuria is a manifestation of metabolic syndrome including HIV-associated lipodystrophy
Design We will use a cross-sectional study design
Population We will enroll 280 patients with HIV disease to the extent practical enrolling consecutive patients in the NIAID Longitudinal HIV Clinic and the Washington Hospital Center HIV Clinic This sample size was determined using an estimated population prevalence of microalbuminuria of 20 with a 90 confidence interval of 5 We will exclude patients with diabetes as screening using urinary albumin excretion is well-established in clinical practice and with established chronic kidney disease defined as macroproteinuria as these patients have been identified by a well-established screening test
Methods We will collect three urine samples at three month intervals for urine albumincreatinine and proteincreatinine ratio We will also collect data on blood pressure anthropomorphometric parameters and various serologic testing Patients with persistent microalbuminuria will undergo renal biopsy Using frozen blood cells we will prepare DNA for genetic testing
Analysis We will determine the prevalence of microalbuminuria in the HIV population sample under study We will determine the clinical implications of microalbuminuria specifically how often HIV-associated collapsing glomerulopathy HIV-associated glomerulonephritis or other histologic disease is present We will correlate the quantitative measure of urinary albumin with 1 the presence or absence of metabolic syndrome and with 2 various quantitative variables associated with metabolic syndrome Finally we will analyze kidney injury genes in particular MYH9 to identify genes that predispose to microalbuminuria
Future Studies If this study suggests that the presence of microalbuminuria identifies patients who are likely to have early glomerular disease we will consider undertaking a prospective controlled trial testing whether therapy with an angiotensin blocker can revert microalbuminuria and reduce progression to macroproteinuria
Background Renal disease is becoming more common as patients with HIV disease live longer Renal diseases in this population include glomerular diseases collapsing glomerulopathy immune complex glomerulonephritis diabetic nephropathy and hypertensive glomerulosclerosis and various tubular diseases Systemic endothelial dysfunction occurring as part of metabolic syndrome and related disorders such as hypertension hyperlipidemia and insulin resistance is also associated with microalbuminuria
Study Objective We wish to determine whether screening for microalbuminuria will detect early stage glomerular disease We also wish to determine whether in some subjects renal histology is normal and microalbuminuria is a manifestation of metabolic syndrome including HIV-associated lipodystrophy
Design We will use a cross-sectional study design
Population We will enroll 280 patients with HIV disease to the extent practical enrolling consecutive patients in the NIAID Longitudinal HIV Clinic and the Washington Hospital Center HIV Clinic This sample size was determined using an estimated population prevalence of microalbuminuria of 20 with a 90 confidence interval of 5 We will exclude patients with diabetes as screening using urinary albumin excretion is well-established in clinical practice and with established chronic kidney disease defined as macroproteinuria as these patients have been identified by a well-established screening test
Methods We will collect three urine samples at three month intervals for urine albumincreatinine and proteincreatinine ratio We will also collect data on blood pressure anthropomorphometric parameters and various serologic testing Patients with persistent microalbuminuria will undergo renal biopsy Using frozen blood cells we will prepare DNA for genetic testing
Analysis We will determine the prevalence of microalbuminuria in the HIV population sample under study We will determine the clinical implications of microalbuminuria specifically how often HIV-associated collapsing glomerulopathy HIV-associated glomerulonephritis or other histologic disease is present We will correlate the quantitative measure of urinary albumin with 1 the presence or absence of metabolic syndrome and with 2 various quantitative variables associated with metabolic syndrome Finally we will analyze kidney injury genes in particular MYH9 to identify genes that predispose to microalbuminuria
Future Studies If this study suggests that the presence of microalbuminuria identifies patients who are likely to have early glomerular disease we will consider undertaking a prospective controlled trial testing whether therapy with an angiotensin blocker can revert microalbuminuria and reduce progression to macroproteinuria
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 |
|---|---|---|---|
| 07-DK-0212 | None | None | None |