Chronic Kidney DiseaseHIVERSNCT00821847
Renal Function Assessment in HIV Patient
An observational study of Chronic Kidney Disease and HIV Infections, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Recent progress in antiretroviral therapy has turned HIV infection into a chronic disease. Patients survival has dramatically improved but complications may occur that need to be prevented and monitored. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Chronic Kidney Disease, HIV Infections
- What is being tested?
- DEXA scan
- How many people
- 45 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2009to Mar 2012
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: male, caucasian, HIV infected patients with glomerular filtration rate between 60 and 30 ml/min (estimated with cockcroft and Gault formulae)
Who may be able to join
- 18 Years and older
- Patients must have detectable HIV-1 by western-blot consent signature
- Estimated glomerular filtration rate, by Modification of Diet in Renal Disease (MDRD) or Cockcroft equation, between 30 and 60 ml/min/1.73m2
- Male
- Caucasian
- Patient provides informed consent
- Patient able to respect the protocol
- social security affiliation
Who cannot join
- acute renal failure
- dysthyroidal function
- metallic prosthesis
- unable to understand the informed consent document
- venous puncture impossible
- receiving steroids
- no possible follow up
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Markers of Glomerular Filtration Rate in the HIV Infected Patient - Role of Body Composition
Recent progress in antiretroviral therapy has turned HIV infection into a chronic disease. Patients survival has dramatically improved but complications may occur that need to be prevented and monitored. As much as 10 % of HIV patients may suffer from chronic kidney disease, an affection that is not symptomatic until a very late stage secondary to HIV infection, drugs exposure, hypertension or diabetes. Guidelines have suggested that renal function should be regularly assessed in HIV patients to perform early diagnosis for chronic kidney disease and allow initiation of preventive measures aimed at preserving renal function.
Plasma creatinine dosage is the easiest way to evaluate renal function but glomerular filtration rate estimation from cockcroft or MDRD formulae is a much better indicator of renal function. Other markers like cystatin C may be used. None of these markers has been validated in HIV patients. Therefore our study is aimed at comparing validity of creatinine clearance estimation with Cockcroft and Gault and MDRD formula and cystatin C compared to the gold standard measurement of glomerular renal function.
Read the detailed description
Aim of the study :
The aim of our study is to test the different available markers for the estimation of glomerular filtration rate (GFR) in HIV patients in order to determine which one is the more appropriated in this particular population. We will analyze the role of the variation in muscular mass in the estimation of GFR
Background :
Several lines of evidence point to renal disease becoming an important complication of human immunodeficiency virus infection and therapy. The spectrum of renal disease in the HIV patient has dramatically changed with HIV associated nephropathy becoming less prevalent and chronic kidney disease [CKD] becoming an everyday concern parallel to the prevalence of renal risk factors such as aging, hypertension and diabetes. Different studies have shown that the prevalence of CKD defined as an estimated glomerular filtration rate below 60 ml/min/1.73m2 is around 10% in HIV patients. CKD is associated with increased mortality, a new concept that has emerged in the past years putting CKD in the top 5 critical cardiovascular risk factors. Evaluating individual renal function in HIV patients allows better care in prevention of cardiovascular events as well as initiation of nephro-protection strategies in order to slow down the loss of renal function and alleviate or postpone the need for dialysis. Since HIV patients also receive chronic multi-therapy, evaluating renal function is also mandatory to allow drug dosage adaptation.
Plasma creatinine dosage is routinely used to estimate GFR but it is closely correlated to age, sex, weight and ethnic origin of the patients. All these factors make creatinine unreliable for GFR estimation. Laboratory dosage of creatinine may be performed with different techniques (JAFFE or enzymatic dosage) with a 20% variation in the results for the same patient. None of the GFR estimation formulae (Cockcroft et Gault or MDRD) have been validated in HIV patients. Cystatin C, a new marker still under evaluation, seems to show some interest in such patients because of its relative independency with regard to muscle mass, but has not been tested in HIV patients. Some cystatin C based formulae have been proposed but not yet tested and validated in HIV patients. HIV infected patients may exhibit abnormal body composition particularly affecting lipids but also, as shown recently, muscle mass. Our study will precisely measure body composition in order to allow interpretation of the variations of the renal markers with regard to muscle mass.
METHODS :
60 patients (men, caucasians) with an estimated GFR between 60 and 15 ml/min/1.73m2 will be included in the study. After giving all necessary information and collection of informed consent, blood will be drown to allow creatinine, cystatin C, albumin, C reactive protein and urea dosages. GFR will be measured using plasmatic clearance of EDTA-51Cr. Body composition will be performed using DEXA scan. Two visits will be necessary to complete the evaluation for every patient, scheduled at the same time than the routine medical visits.
Expected results :
Our study should allow better definition of the ideal marker for GFR in HIV infected male. Il will also afford better comprehension of the factors involved in the variation of creatinine dosage in this population namely those related to the biochemical dosage and to the change in body composition.
Conclusion :
HIV infection and its treatment is definitely a serious risk factor for renal disease. Although, optimal care for HIV-infected patients becomes more and more complex due to multiple comorbidities, efforts must be made to diagnose a decline in glomerular filtration rate in order to provide improved control of CKD-associated cardiovascular risk and optimized antiretroviral therapy. Therefore evaluating glomerular filtration rate is critical in HIV-infected patients to allow determination of the optimum follow up strategy and the critical therapeutic measures, namely drug dosage adaptation.
- Conditions
- Chronic Kidney Disease, HIV Infections
- Being tested
- DEXA scan
- Keywords
- HIV, glomerular filtration rate, cockcroft, MDRD formula, creatinine, cystatin C, isotopic clearance, EDTA-51Cr, DEXA scan
- Medical subject headings
- Renal Insufficiency, Chronic, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DEXA scanOther
DEXA scan
| Study group | Role | What they receive |
|---|---|---|
| 1:experimental | male, caucasian, HIV infected patients with glomerular filtration rate between 60 and 30 ml/min (estimated with cockcroft and Gault formulae) Receives: Other: DEXA scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
GFR estimated with Cockcroft and Gault and MDRD formulae and cystatin C dosage compared to isotopic evaluation of GFR
Measured: within 10 weeks after inclusion
Secondary outcomes (2)
Variability of creatinine plasma dosage within two different methods
Measured: during the study
Role of bone density on validity of renal function markers in HIV patients
Measured: during the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2009 (estimated)
- Study startJun 2009
- Primary completionMar 2012
- Study completionMar 2012
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 Assistance Publique - Hôpitaux de ParisThe 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Sidaction
- Responsible party
- Sponsor
- Investigators
- Corinne Isnard Bagnis, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00821847
- Sponsor's protocol ID
- P080202
- Acronym
- HIVERS
- Status last verified
- Jun 2008
- First submitted
- 13 Jan 2009
- Last updated
- 31 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Markers of Glomerular Filtration Rate in the HIV Infected Patient - Role of Body Composition
- ClinicalTrials.gov ID
- NCT00821847
- Acronym / sponsor ID
- HIVERS / P080202
- Conditions
- Chronic Kidney Disease, HIV Infections
- Keywords
- HIV, glomerular filtration rate, cockcroft, MDRD formula, creatinine, cystatin C, isotopic clearance, EDTA-51Cr
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Sidaction
- Study start
- Jun 2009
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 14 Jan 2009 (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.
Recent progress in antiretroviral therapy has turned HIV infection into a chronic disease. Patients survival has dramatically improved but complications may occur that need to be prevented and monitored. As much as 10 % of HIV patients may suffer from chronic kidney disease, an affection that is not symptomatic until a very late stage secondary to HIV infection, drugs exposure, hypertension or diabetes. Guidelines have suggested that renal function should be regularly assessed in HIV patients to perform early diagnosis for chronic kidney disease and allow initiation of preventive measures aimed at preserving renal function.
Plasma creatinine dosage is the easiest way to evaluate renal function but glomerular filtration rate estimation from cockcroft or MDRD formulae is a much better indicator of renal function. Other markers like cystatin C may be used. None of these markers has been validated in HIV patients. Therefore our study is aimed at comparing validity of creatinine clearance estimation with Cockcroft and Gault and MDRD formula and cystatin C compared to the gold standard measurement of glomerular renal function.
Detailed description
Aim of the study :
The aim of our study is to test the different available markers for the estimation of glomerular filtration rate (GFR) in HIV patients in order to determine which one is the more appropriated in this particular population. We will analyze the role of the variation in muscular mass in the estimation of GFR
Background :
Several lines of evidence point to renal disease becoming an important complication of human immunodeficiency virus infection and therapy. The spectrum of renal disease in the HIV patient has dramatically changed with HIV associated nephropathy becoming less prevalent and chronic kidney disease [CKD] becoming an everyday concern parallel to the prevalence of renal risk factors such as aging, hypertension and diabetes. Different studies have shown that the prevalence of CKD defined as an estimated glomerular filtration rate below 60 ml/min/1.73m2 is around 10% in HIV patients. CKD is associated with increased mortality, a new concept that has emerged in the past years putting CKD in the top 5 critical cardiovascular risk factors. Evaluating individual renal function in HIV patients allows better care in prevention of cardiovascular events as well as initiation of nephro-protection strategies in order to slow down the loss of renal function and alleviate or postpone the need for dialysis. Since HIV patients also receive chronic multi-therapy, evaluating renal function is also mandatory to allow drug dosage adaptation.
Plasma creatinine dosage is routinely used to estimate GFR but it is closely correlated to age, sex, weight and ethnic origin of the patients. All these factors make creatinine unreliable for GFR estimation. Laboratory dosage of creatinine may be performed with different techniques (JAFFE or enzymatic dosage) with a 20% variation in the results for the same patient. None of the GFR estimation formulae (Cockcroft et Gault or MDRD) have been validated in HIV patients. Cystatin C, a new marker still under evaluation, seems to show some interest in such patients because of its relative independency with regard to muscle mass, but has not been tested in HIV patients. Some cystatin C based formulae have been proposed but not yet tested and validated in HIV patients. HIV infected patients may exhibit abnormal body composition particularly affecting lipids but also, as shown recently, muscle mass. Our study will precisely measure body composition in order to allow interpretation of the variations of the renal markers with regard to muscle mass.
METHODS :
60 patients (men, caucasians) with an estimated GFR between 60 and 15 ml/min/1.73m2 will be included in the study. After giving all necessary information and collection of informed consent, blood will be drown to allow creatinine, cystatin C, albumin, C reactive protein and urea dosages. GFR will be measured using plasmatic clearance of EDTA-51Cr. Body composition will be performed using DEXA scan. Two visits will be necessary to complete the evaluation for every patient, scheduled at the same time than the routine medical visits.
Expected results :
Our study should allow better definition of the ideal marker for GFR in HIV infected male. Il will also afford better comprehension of the factors involved in the variation of creatinine dosage in this population namely those related to the biochemical dosage and to the change in body composition.
Conclusion :
HIV infection and its treatment is definitely a serious risk factor for renal disease. Although, optimal care for HIV-infected patients becomes more and more complex due to multiple comorbidities, efforts must be made to diagnose a decline in glomerular filtration rate in order to provide improved control of CKD-associated cardiovascular risk and optimized antiretroviral therapy. Therefore evaluating glomerular filtration rate is critical in HIV-infected patients to allow determination of the optimum follow up strategy and the critical therapeutic measures, namely drug dosage adaptation.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1:experimental | – | Other: DEXA scanmale, caucasian, HIV infected patients with glomerular filtration rate between 60 and 30 ml/min (estimated with cockcroft and Gault formulae) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- male, caucasian, HIV infected patients with glomerular filtration rate between 60 and 30 ml/min (estimated with cockcroft and Gault formulae)
Key inclusion criteria (8 listed)
- 18 Years and older
- Patients must have detectable HIV-1 by western-blot consent signature
- Estimated glomerular filtration rate, by Modification of Diet in Renal Disease (MDRD) or Cockcroft equation, between 30 and 60 ml/min/1.73m2
- Male
- Caucasian
Key exclusion criteria (7 listed)
- acute renal failure
- dysthyroidal function
- metallic prosthesis
- unable to understand the informed consent document
- venous puncture impossible
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 |
|---|---|---|
| DEXA scanDEXA scan | Other | 1:experimental |
Primary outcome
GFR estimated with Cockcroft and Gault and MDRD formulae and cystatin C dosage compared to isotopic evaluation of GFR
Time frame: within 10 weeks after inclusion
2 secondary outcomes
Variability of creatinine plasma dosage within two different methods
Time frame: during the study
Role of bone density on validity of renal function markers in HIV patients
Time frame: during the study
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 31 Jul 2012.
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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.
Corinne Isnard Bagnis, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
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 HIV Infections, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 8 inclusion and 7 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 31 Jul 2012. 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 France. 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.
What does the primary outcome measure?
GFR estimated with Cockcroft and Gault and MDRD formulae and cystatin C dosage compared to isotopic evaluation of GFR (time frame: within 10 weeks after inclusion). It is what the study was designed to measure, not a finding.
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 31 Jul 2012.