NephrolithiasisCALVIHNCT02457494
Kidney Stone Risk Factors in Patients Infected With HIV
An observational study of Nephrolithiasis and HIV, run by Corinne Isnard Bagnis at 1 site in France.
Trial summary
The purpose of this study is to define the cause of renal stones and the risk pattern for recurrence of renal stones episodes (any kind of stones) in HIV1 patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nephrolithiasis, HIV
- How many people
- 23 participants
- Where
- 1 siteFrance
- Study dates
- May 2015to Mar 2018
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult male or female HIV1 infected patients having experienced a renal stone episode within the past six months or living with a renal stone
Who may be able to join
- Adult male or female HIV1 infected patients willing to participate in the study
- Having experienced a renal stone episode within the past six months or living with a renal stone
- Able to understand the protocol
- Giving oral consent
Who cannot join
- CT scan impossible
- Follow up impossible over 1 year
Trial locations and contacts
1 site in 1 country.
About this study
Official title: CALVIH: Determination of Kidney Stone Risk Factors in Patients Infected With HIV
The purpose of this study is to define the cause of renal stones and the risk pattern for recurrence of renal stones episodes (any kind of stones) in HIV1 patients.
Read the detailed description
This study aims at defining the cause of renal stones and the risk pattern for recurrence of renal stones episodes (any kind of stones) in HIV1 patients.
Primary Objective :
- Finding the cause of renal stone in HIV patients defined as stone composition if stone is available or more probable pathophysiological mechanism
- Risk profile for stone recurrences estimated on risk indices in HIV1 patients
Secondary Objective(s)
- Identify prevalence of recurrences and describe co-morbidities associated with stone disease
- Describe urological management for renal stones in HIV patients
- Describe the causes of drug induced renal stones
- Conditions
- Nephrolithiasis, HIV
- Keywords
- CALVIH, Renal stone, HIV1, Renal colic, Atazanavir, Crystalluria, Chronic Kidney Disease, Calcium Oxalate
- Medical subject headings
- Nephrolithiasis, Renal Colic, Crystalluria, Renal Insufficiency, Chronic
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualitative assessment of the cause of the renal stone
Qualitative assessment of the cause of the renal stone based on different biological and clinical parameters (biochemical analysis of urines, cristalluria, low dose renal CT, patient history, family history…)
Measured: at 6 months
Risk profile for recurrence of renal stone
Risk profile for recurrence of renal stone estimated based on plasma and urinary parameters, nutritional profile and drug exposure
Measured: at 12 months
Secondary outcomes (5)
Follow up outcome of HIV patients over one year to identify prevalence of recurrences and describe co-morbidities associated with stone disease
Measured: up to 12 months
Urological management for renal stones in HIV patients
Measured: up to 12 months
Causes of drug induced renal stones
Measured: up to 12 months
Number of stone recurrences
Measured: at 6 months
Number of stone recurrences
Measured: at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2015 (estimated)
- Study startMay 2015
- Primary completionOct 2017
- Study completionMar 2018
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 NephrolithiasisStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corinne Isnard Bagnis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Corinne Isnard Bagnis, Association pour le Developpement d'Investigations et de Thérapeutiques en Néphrologie
- Investigators
- corinne i bagnis, Principal investigator, Groupe Hospitalier Pitie Salpetriere et Chaire de Recherche en Education Therapeutique
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02457494
- Sponsor's protocol ID
- Al424-986
- Acronym
- CALVIH
- Status last verified
- Jul 2022
- First submitted
- 22 May 2015
- Last updated
- 20 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Abgrall S, Rachas A, Tourret J, Isnard-Bagnis C, Billaud E, Tattevin P, Costagliola D, Guiguet M, Durieux P; French Hospital Database on HIV. A multifaceted intervention designed to improve medical management of moderate to advanced chronic kidney disease in HIV-infected patients: a cluster randomized trial. Clin Infect Dis. 2015 Aug 1;61(3):375-84. doi: 10.1093/cid/civ310. Epub 2015 Apr 22.
PubMed 25904366Tourret J, Deray G, Isnard-Bagnis C. Tenofovir effect on the kidneys of HIV-infected patients: a double-edged sword? J Am Soc Nephrol. 2013 Oct;24(10):1519-27. doi: 10.1681/ASN.2012080857. Epub 2013 Sep 19.
PubMed 24052632Bige N, Lanternier F, Viard JP, Kamgang P, Daugas E, Elie C, Jidar K, Walker-Combrouze F, Peraldi MN, Isnard-Bagnis C, Servais A, Lortholary O, Noel LH, Bollee G. Presentation of HIV-associated nephropathy and outcome in HAART-treated patients. Nephrol Dial Transplant. 2012 Mar;27(3):1114-21. doi: 10.1093/ndt/gfr376. Epub 2011 Jul 10.
PubMed 21745806Tourret J, Tostivint I, Deray G, Isnard-Bagnis C. [Kidney diseases in HIV-infected patients]. Nephrol Ther. 2009 Nov;5(6):576-91. doi: 10.1016/j.nephro.2009.02.007. Epub 2009 Apr 16. French.
PubMed 19375399
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CALVIH: Determination of Kidney Stone Risk Factors in Patients Infected With HIV
- ClinicalTrials.gov ID
- NCT02457494
- Acronym / sponsor ID
- CALVIH / Al424-986
- Conditions
- Nephrolithiasis, HIV
- Keywords
- CALVIH, Renal stone, HIV1, Renal colic, Atazanavir, Crystalluria, Chronic Kidney Disease, Calcium Oxalate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Corinne Isnard BagnisUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Oct 2017 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 29 May 2015 (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.
The purpose of this study is to define the cause of renal stones and the risk pattern for recurrence of renal stones episodes (any kind of stones) in HIV1 patients.
Detailed description
This study aims at defining the cause of renal stones and the risk pattern for recurrence of renal stones episodes (any kind of stones) in HIV1 patients.
Primary Objective :
- Finding the cause of renal stone in HIV patients defined as stone composition if stone is available or more probable pathophysiological mechanism
- Risk profile for stone recurrences estimated on risk indices in HIV1 patients
Secondary Objective(s)
- Identify prevalence of recurrences and describe co-morbidities associated with stone disease
- Describe urological management for renal stones in HIV patients
- Describe the causes of drug induced renal stones
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult male or female HIV1 infected patients having experienced a renal stone episode within the past six months or living with a renal stone
Key inclusion criteria (4 listed)
- Adult male or female HIV1 infected patients willing to participate in the study
- Having experienced a renal stone episode within the past six months or living with a renal stone
- Able to understand the protocol
- Giving oral consent
Key exclusion criteria (2 listed)
- CT scan impossible
- Follow up impossible over 1 year
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
Qualitative assessment of the cause of the renal stone
Time frame: at 6 months
Qualitative assessment of the cause of the renal stone based on different biological and clinical parameters (biochemical analysis of urines, cristalluria, low dose renal CT, patient history, family history…)
Risk profile for recurrence of renal stone
Time frame: at 12 months
Risk profile for recurrence of renal stone estimated based on plasma and urinary parameters, nutritional profile and drug exposure
5 secondary outcomes
Follow up outcome of HIV patients over one year to identify prevalence of recurrences and describe co-morbidities associated with stone disease
Time frame: up to 12 months
Urological management for renal stones in HIV patients
Time frame: up to 12 months
Causes of drug induced renal stones
Time frame: up to 12 months
Number of stone recurrences
Time frame: at 6 months
Number of stone recurrences
Time frame: at 12 months
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 20 Jul 2022.
- Results publication: PubMed 25904366Abgrall S, Rachas A, Tourret J, Isnard-Bagnis C, Billaud E, Tattevin P, Costagliola D, Guiguet M, Durieux P; French Hospital Database on HIV. A multifaceted intervention designed to improve medical management of moderate to advanced chronic kidney disease in HIV-infected patients: a cluster randomized trial. Clin Infect Dis. 2015 Aug 1;61(3):375-84. doi: 10.1093/cid/civ310. Epub 2015 Apr 22.
- Results publication: PubMed 24052632Tourret J, Deray G, Isnard-Bagnis C. Tenofovir effect on the kidneys of HIV-infected patients: a double-edged sword? J Am Soc Nephrol. 2013 Oct;24(10):1519-27. doi: 10.1681/ASN.2012080857. Epub 2013 Sep 19.
- Results publication: PubMed 21745806Bige N, Lanternier F, Viard JP, Kamgang P, Daugas E, Elie C, Jidar K, Walker-Combrouze F, Peraldi MN, Isnard-Bagnis C, Servais A, Lortholary O, Noel LH, Bollee G. Presentation of HIV-associated nephropathy and outcome in HAART-treated patients. Nephrol Dial Transplant. 2012 Mar;27(3):1114-21. doi: 10.1093/ndt/gfr376. Epub 2011 Jul 10.
- Results publication: PubMed 19375399Tourret J, Tostivint I, Deray G, Isnard-Bagnis C. [Kidney diseases in HIV-infected patients]. Nephrol Ther. 2009 Nov;5(6):576-91. doi: 10.1016/j.nephro.2009.02.007. Epub 2009 Apr 16. French.
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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 i bagnis principal investigator
Groupe Hospitalier Pitie Salpetriere et Chaire de Recherche en Education Therapeutique
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 Nephrolithiasis and HIV, run by Corinne Isnard Bagnis 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 4 inclusion and 2 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 20 Jul 2022. 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?
Qualitative assessment of the cause of the renal stone (time frame: at 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02457494, 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 20 Jul 2022.