HIV-Associated Focal Segmental GlomerulosclerosisNCT00524992
Evaluation of Albuminuria HIV-Infected Patients
An observational study of HIV-Associated Focal Segmental Glomerulosclerosis and HIV-Associated Collapsing Glomerulopathy, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 years and older
- Conditions the study is for
- HIV-Associated Focal Segmental Glomerulosclerosis, HIV-Associated Collapsing Glomerulopathy, Proteinuria
- How many people
- 252 participants
- Where
- 2 sitesUnited States
- Study dates
- 29 Aug 2007to 24 Dec 2014
- 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 8 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- HIV+ adults and children greater than 8 years of age
Who cannot join
- Inability or unwillingness to give consent or assent or to comply with study requirements
- Unable to return to NIH or Washington Hospital Center for two follow-up visits over a 9-month period
- New opportunistic or bacterial infection within past 3 months or active opportunistic infection.
- Active malignancy, other than non-melanoma skin cancer and cutaneous Kaposi sarcoma not requiring treatment. Rationale: systemic inflammation may induce microalbuminuria.
- Diabetes by history
- IL-2, IL-7 or IFN-alpha therapy within past 3 months. Rationale: IL-2 and IFN-alpha therapy induce renal dysfunction and IL-7 may be associated with systemic inflammation.
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- Non compliance, alcohol use, and drug use are conditions that make study completion unlikely or difficult.
- Diabetes (fasting glucose greater than 125 mg/dL or 2 hour oral glucose tolerance value greater than or equal to 200 mg/dL or current diagnosis of diabetes).
- Serum creatinine greater than 1.4 mg/dL.
- Urine protein/creatinine ratio greater than 0.5 and sustained on at least 2 measurements.
- Pregnant Women
Trial locations and contacts
2 sites in 1 country.
United States2 sites
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
Washington Hospital Center
Washington D.C., District of Columbia, 20010
About this study
Official title: Prospective Evaluation of Albuminuria in HIV Positive Patients
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.
Read more
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.
Read the 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 albumin/creatinine and protein/creatinine 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.
- Conditions
- HIV-Associated Focal Segmental Glomerulosclerosis, HIV-Associated Collapsing Glomerulopathy, Proteinuria, Albuminuria, Renal Tubular Toxicity
- Keywords
- Focal Segmental Glomerulosclerosis, Collapsing Glomerulopathy, Anti-Retroviral Toxicity, Lipodystrophy, Metabolic Syndrome, Tubular Injury, Renal Biopsy, Proteinuria, Tenofovir Toxicity, HAART Toxicity, HIV Positive, HIV-Associated Focal Segmental Glomerulosclerosis
- Medical subject headings
- Proteinuria, Albuminuria, Glomerulosclerosis, Focal Segmental, Lipodystrophy, Metabolic Syndrome, HIV Seropositivity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2007 (estimated)
- Study start29 Aug 2007
- Study completion24 Dec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HIV-Associated Focal Segmental GlomerulosclerosisStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The 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
- Time perspective
- Prospective
- Enrolment
- 252 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Jeffrey B Kopp, M.D., Principal investigator, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00524992
- Sponsor's protocol ID
- 070212
- Other IDs
- 07-DK-0212
- Status last verified
- 24 Dec 2014
- First submitted
- 1 Sep 2007
- Last updated
- 5 Apr 2018
- Results posted
- No
Publications
Han TM, Naicker S, Ramdial PK, Assounga AG. A cross-sectional study of HIV-seropositive patients with varying degrees of proteinuria in South Africa. Kidney Int. 2006 Jun;69(12):2243-50. doi: 10.1038/sj.ki.5000339. Epub 2006 May 3.
PubMed 16672914Jones CA, Francis ME, Eberhardt MS, Chavers B, Coresh J, Engelgau M, Kusek JW, Byrd-Holt D, Narayan KM, Herman WH, Jones CP, Salive M, Agodoa LY. Microalbuminuria in the US population: third National Health and Nutrition Examination Survey. Am J Kidney Dis. 2002 Mar;39(3):445-59. doi: 10.1053/ajkd.2002.31388.
PubMed 11877563Chavers BM, Bilous RW, Ellis EN, Steffes MW, Mauer SM. Glomerular lesions and urinary albumin excretion in type I diabetes without overt proteinuria. N Engl J Med. 1989 Apr 13;320(15):966-70. doi: 10.1056/NEJM198904133201503.
PubMed 2784542Hadigan C, Edwards E, Rosenberg A, Purdy JB, Fleischman E, Howard L, Mican JM, Sampath K, Oyalowo A, Johnson A, Adler A, Rehm C, Smith M, Lai L, Kopp JB. Microalbuminuria in HIV disease. Am J Nephrol. 2013;37(5):443-51. doi: 10.1159/000350384. Epub 2013 Apr 20.
PubMed 23615312
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Albuminuria in HIV Positive Patients
- ClinicalTrials.gov ID
- NCT00524992
- Acronym / sponsor ID
- 070212
- Conditions
- HIV-Associated Focal Segmental Glomerulosclerosis, HIV-Associated Collapsing Glomerulopathy, Proteinuria, Albuminuria, Renal Tubular Toxicity
- Keywords
- Focal Segmental Glomerulosclerosis, Collapsing Glomerulopathy, Anti-Retroviral Toxicity, Lipodystrophy, Metabolic Syndrome, Tubular Injury, Renal Biopsy, Proteinuria
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 252 participants (actual)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- 29 Aug 2007
- Study completion
- 24 Dec 2014
- First posted
- 5 Sep 2007 (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.
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.
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 albumin/creatinine and protein/creatinine 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 design
- Time perspective
- Prospective
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- HIV+ adults and children greater than 8 years of age
Key exclusion criteria (11 listed)
- Inability or unwillingness to give consent or assent or to comply with study requirements
- Unable to return to NIH or Washington Hospital Center for two follow-up visits over a 9-month period
- New opportunistic or bacterial infection within past 3 months or active opportunistic infection.
- Active malignancy, other than non-melanoma skin cancer and cutaneous Kaposi sarcoma not requiring treatment. Rationale: systemic inflammation may induce microalbuminuria.
- Diabetes by history
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
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 5 Apr 2018.
- Background: PubMed 16672914Han TM, Naicker S, Ramdial PK, Assounga AG. A cross-sectional study of HIV-seropositive patients with varying degrees of proteinuria in South Africa. Kidney Int. 2006 Jun;69(12):2243-50. doi: 10.1038/sj.ki.5000339. Epub 2006 May 3.
- Background: PubMed 11877563Jones CA, Francis ME, Eberhardt MS, Chavers B, Coresh J, Engelgau M, Kusek JW, Byrd-Holt D, Narayan KM, Herman WH, Jones CP, Salive M, Agodoa LY. Microalbuminuria in the US population: third National Health and Nutrition Examination Survey. Am J Kidney Dis. 2002 Mar;39(3):445-59. doi: 10.1053/ajkd.2002.31388.
- Background: PubMed 2784542Chavers BM, Bilous RW, Ellis EN, Steffes MW, Mauer SM. Glomerular lesions and urinary albumin excretion in type I diabetes without overt proteinuria. N Engl J Med. 1989 Apr 13;320(15):966-70. doi: 10.1056/NEJM198904133201503.
- Derived from this study: PubMed 23615312Hadigan C, Edwards E, Rosenberg A, Purdy JB, Fleischman E, Howard L, Mican JM, Sampath K, Oyalowo A, Johnson A, Adler A, Rehm C, Smith M, Lai L, Kopp JB. Microalbuminuria in HIV disease. Am J Nephrol. 2013;37(5):443-51. doi: 10.1159/000350384. Epub 2013 Apr 20.
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.
Jeffrey B Kopp, M.D. principal investigator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV-Associated Focal Segmental Glomerulosclerosis and HIV-Associated Collapsing Glomerulopathy, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 2 sites 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 1 inclusion and 11 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 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
On the ClinicalTrials.gov record for NCT00524992, which also lists 4 linked publications.
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 Apr 2018.