ProteinuriaPhase 4MARCHrenalNCT01637259
MARCH Renal Substudy
A Phase 4 study testing arm 1 nucleotide analogue reverse transcriptase inhibitors and boosted protease inhibitors, Arm 2 boosted protease inhibitors and maraviroc and Arm 3 nucleotide analogue reverse transcriptase inhibitors and maraviroc in people with Proteinuria and HIV, run by Kirby Institute at 15 sites in 8 countries.
Trial summary
Chronic kidney disease (CKD) is an emerging problem in patients with treated HIV. Antiretroviral therapy associated renal dysfunction has been predominantly described in terms of reduced glomerular filtration (eGFR). Proteinuria is a key component of CKD and may occur in the absence of significant reductions in eGFR. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Proteinuria, HIV
- What is being tested?
- arm 1 nucleotide analogue reverse transcriptase inhibitors and boosted protease inhibitors, Arm 2 boosted protease inhibitors and maraviroc and Arm 3 nucleotide analogue reverse transcriptase inhibitors and maraviroc
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 15 sitesin 8 countries
- Study dates
- Jun 2012to Dec 2015
- Phase
- Phase 4
- 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
Who may be able to join
- Provision of written, informed consent for participation in the substudy
- Enrolled into the substudy either at or before the week 0 visit of the main study
Who cannot join
None listed.
Trial locations and contacts
15 sites in 8 countries.
15 sites in 8 countries
Argentina3 sites
Hospital Italiano de Buenos Aires
Buenos Aires, Buenos Aires F.D., C1181ACH
Hospital General de Agudos J M Ramos Mejia
Buenos Aires, Buenos Aires F.D., C1221ADC
Fundación IDEAA
Buenos Aires, Buenos Aires F.D., C1405CKC
Canada3 sites
Southern Alberta Clinic
Calgary, Alberta, T2R OX7
Clinic Opus/Lori
Montreal, Quebec, H3A 1T1
University Health Network - Toronto General Hospital
Toronto, Ontario, M5G 2N2
Australia2 sites
Brisbane Sexual Health and HIV Service
Brisbane, Queensland, 4000
St. Vincent's Hospital
Sydney, New South Wales, 2010
Germany2 sites
Klinikum der Universitat Zu Koln
Cologne, 50937
Universitätsklinikum Düsseldorf, Klinik für Gastroenterologie, Hepatologie und Infektiologie, MX-Ambulanz
Düsseldorf, 40225
United Kingdom2 sites
Brighton & Sussex University NHS Trust
Brighton, Sussex
Western General Hospital
Edinburgh, Lothian
Mexico1 site
Instituto Nacional de Ciencias Medicas y Nutriciòn Salvador Zubiran
Mexico City, Tlalpan DF, 14000
About this study
Official title: Maraviroc Switch Collaborative Study Renal Substudy
Chronic kidney disease (CKD) is an emerging problem in patients with treated HIV. Antiretroviral therapy associated renal dysfunction has been predominantly described in terms of reduced glomerular filtration (eGFR). Proteinuria is a key component of CKD and may occur in the absence of significant reductions in eGFR. This substudy is an exploration of changes in urinary protein excretion in a randomised, open-label study to evaluate the efficacy and safety of MVC as a switch for either nucleoside or nucleotide analogue reverse transcriptase inhibitors (N(t)RTI) or boosted protease inhibitors (PI/r) in HIV-1 infected individuals with stable, well-controlled plasma HIV-RNA while taking their first N(t)RTI + PI/r regimen of combination antiretroviral therapy (cART).
Read the detailed description
The aim of this substudy of MARCH is to characterize the changes in protein and salt excretion through the kidney utilising the randomised arms of the parent study MARCH. The investigators hypothesize there will be an improvement in proteinuria in those switching to maraviroc containing regimens.
- Conditions
- Proteinuria, HIV
- Being tested
- arm 1 nucleotide analogue reverse transcriptase inhibitors and boosted protease inhibitors, Arm 2 boosted protease inhibitors and maraviroc, Arm 3 nucleotide analogue reverse transcriptase inhibitors and maraviroc
- Keywords
- proteinuria, HIV
- Medical subject headings
- Proteinuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
arm 1 nucleotide analogue reverse transcriptase inhibitors and boosted protease inhibitorsDrug
Also called tenofovir, emtricitabine, zidovudine, abacavir
NRTI + PI
Arm 2 boosted protease inhibitors and maravirocDrug
Also called maraviroc, atazanavir, lopinavir, darunavir
PI + maraviroc
Arm 3 nucleotide analogue reverse transcriptase inhibitors and maravirocDrug
Also called maraviroc, tenofovir, emtricitabine, zidovudine
NRTI + maraviroc
| Study group | Role | What they receive |
|---|---|---|
| NRTI + PI | Active comparator | arm 1 Receives: Drug: arm 1 nucleotide analogue reverse transcriptase inhibitors and boosted protease inhibitors |
| PI + maraviroc | Active comparator | arm 2 Receives: Drug: Arm 2 boosted protease inhibitors and maraviroc |
| NRTI + maraviroc | Active comparator | arm 3 Receives: Drug: Arm 3 nucleotide analogue reverse transcriptase inhibitors and maraviroc |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in proteinuria and albuminuria between baseline and week 96
To compare the change in protein and albumin excretion as measured by the urine PCR and ACR through the kidneys between the randomised and standard of care (control) arm of MARCH.
Measured: 96 weeks
Secondary outcomes (1)
changes in renal tubular function between baseline and week 96
To evaluate the following aspects of renal function at baseline and changes within and between study groups:
- Tubular function defined as proximal tubular function; ascending thick loop of Henle; distal tubular function; volume and renal potassium handling;
- Non-tubular function i.e. eGFR; Urine albumin:creatinine ratio;
- Determine factors associated with renal dysfunction within the cohort e.g. demographics, HIV related, HIV-treatment related, co-morbidities, concomitant medication (such as ACE inhibitors and ARB; PI/r co-administered with TDF); TDF use;
Measured: 96 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2012 (estimated)
- Study startJun 2012
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ProteinuriaStudies 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
- Interventional
- Phase
- Phase 4
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kirby Institute
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Waldo Belloso, MD, Principal investigator, Hospital Italiano de Buenos AiresMark Kelly, MD, Principal investigator, Brisbane Sexual Health and HIV Service
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01637259
- Sponsor's protocol ID
- MARCH-Kirby renal
- Acronym
- MARCHrenal
- Status last verified
- Jan 2016
- First submitted
- 27 Jun 2012
- Last updated
- 20 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maraviroc Switch Collaborative Study Renal Substudy
- ClinicalTrials.gov ID
- NCT01637259
- Acronym / sponsor ID
- MARCHrenal / MARCH-Kirby renal
- Conditions
- Proteinuria, HIV
- Keywords
- proteinuria, HIV
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Kirby InstituteOther government
- Study start
- Jun 2012
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 11 Jul 2012 (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.
Chronic kidney disease (CKD) is an emerging problem in patients with treated HIV. Antiretroviral therapy associated renal dysfunction has been predominantly described in terms of reduced glomerular filtration (eGFR). Proteinuria is a key component of CKD and may occur in the absence of significant reductions in eGFR. This substudy is an exploration of changes in urinary protein excretion in a randomised, open-label study to evaluate the efficacy and safety of MVC as a switch for either nucleoside or nucleotide analogue reverse transcriptase inhibitors (N(t)RTI) or boosted protease inhibitors (PI/r) in HIV-1 infected individuals with stable, well-controlled plasma HIV-RNA while taking their first N(t)RTI + PI/r regimen of combination antiretroviral therapy (cART).
Detailed description
The aim of this substudy of MARCH is to characterize the changes in protein and salt excretion through the kidney utilising the randomised arms of the parent study MARCH. The investigators hypothesize there will be an improvement in proteinuria in those switching to maraviroc containing regimens.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NRTI + PI | Active comparator | Drug: arm 1 nucleotide analogue reverse transcriptase inhibitors and boosted protease inhibitorsarm 1 |
| PI + maraviroc | Active comparator | Drug: Arm 2 boosted protease inhibitors and maravirocarm 2 |
| NRTI + maraviroc | Active comparator | Drug: Arm 3 nucleotide analogue reverse transcriptase inhibitors and maravirocarm 3 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Provision of written, informed consent for participation in the substudy
- Enrolled into the substudy either at or before the week 0 visit of the main study
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| arm 1 nucleotide analogue reverse transcriptase inhibitors and boosted protease inhibitorsAlso: tenofovir, emtricitabine, zidovudine, abacavirNRTI + PI | Drug | NRTI + PI |
| Arm 2 boosted protease inhibitors and maravirocAlso: maraviroc, atazanavir, lopinavir, darunavirPI + maraviroc | Drug | PI + maraviroc |
| Arm 3 nucleotide analogue reverse transcriptase inhibitors and maravirocAlso: maraviroc, tenofovir, emtricitabine, zidovudineNRTI + maraviroc | Drug | NRTI + maraviroc |
Primary outcome
changes in proteinuria and albuminuria between baseline and week 96
Time frame: 96 weeks
To compare the change in protein and albumin excretion as measured by the urine PCR and ACR through the kidneys between the randomised and standard of care (control) arm of MARCH.
1 secondary outcome
changes in renal tubular function between baseline and week 96
Time frame: 96 weeks
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 Jan 2016.
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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.
Waldo Belloso, MD principal investigator
Hospital Italiano de Buenos Aires
Mark Kelly, MD principal investigator
Brisbane Sexual Health and HIV Service
15 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing arm 1 nucleotide analogue reverse transcriptase inhibitors and boosted protease inhibitors, Arm 2 boosted protease inhibitors and maraviroc and Arm 3 nucleotide analogue reverse transcriptase inhibitors and maraviroc in people with Proteinuria and HIV, run by Kirby Institute at 15 sites in 8 countries.
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 2 inclusion and 0 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 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Argentina, Canada, Australia, Germany, United Kingdom and 3 more countries. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
changes in proteinuria and albuminuria between baseline and week 96 (time frame: 96 weeks). 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 20 Jan 2016.