IGA GlomerulonephritisNCT02527902
Autonomic Nervous System (ANS) and Renal Function in Immunoglobin A (IgA) Nephropathy
A study testing Holter in people with IGA Glomerulonephritis, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
The estimation of the cardiovascular risk in the general population must take into account small renal disturbances, as the microalbuminuria. Conversely certain parameters of the cardiovascular risk influence the evolution of renal diseases, for example the arterial high blood pressure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- IGA Glomerulonephritis
- What is being tested?
- Holter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2011to Apr 2012
- Phase
- Interventional
- 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
- diagnosis of IgNA biopsy-proven free, informed, express and written
Who cannot join
- IgNA secondary to Henoch-Schonlein purpura (HSP) or Systemic Lupus Erythematosus or alcoholic cirrhosis
- current kidney transplantation
- Hypertension treated or not,
- Diseases interfering with ANS analysis: cardiac arrhythmia, beta-blocker therapy
- diabetes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Autonomic Nervous System (ANS) Analysis According to Different Renal Function Stage in Immunoglobin A (IgA) Nephropathy
The estimation of the cardiovascular risk in the general population must take into account small renal disturbances, as the microalbuminuria. Conversely certain parameters of the cardiovascular risk influence the evolution of renal diseases, for example the arterial high blood pressure.
The measure of the activity of the autonomous nervous system, and especially the quantification of its variability, is a means to estimate the cardiovascular risk. The investigators formulate the hypothesis that the variability of the autonomous nervous system is an additional clinical element for the evaluation of the evolutionary risk of renal diseases.
Read more
The aim of this study is to compare the variability of the autonomous nervous system during the various evolutionary stages of the renal disease.
The renal disease studied will be IgA nephropathy (IgNA). IgNA is a histologically defined glomerulonephritis (rela biopsy) by the presence of deposits immunoglobulin A (IgA) in the renal mesangium (at list 1+) by immunofluorescence.
- Conditions
- IGA Glomerulonephritis
- Being tested
- Holter
- Keywords
- IGA Glomerulonephritis, Autonomic nervous system, ANS
- Medical subject headings
- Glomerulonephritis, IGA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HolterDevice
measure of ANS in IgAN patients
| Study group | Role | What they receive |
|---|---|---|
| IgAN with glomerular filtration rate (GFR) >90 ml/min/1.73 m2 | Experimental | Measure of ANS by holter device in IgAN patients with glomerular filtration rate (GFR) >90 ml/min/1.73 m2 Receives: Device: Holter |
| IgAN with GFR 60-89 ml/min/1.73 m2 | Experimental | Measure of ANS by holter device in IgAN patients with GFR 60-89 ml/min/1.73 m2 Receives: Device: Holter |
| IgAN with GFR 30-59 ml/min/1.73 m2 | Experimental | Measure of ANS by holter device in IgAN patients with GFR 30-59 ml/min/1.73 m2 Receives: Device: Holter |
| IgAN with GFR 15-29 ml/min/1.73 m2 | Experimental | Measure of ANS by holter device in IgAN patients with GFR 15-29 ml/min/1.73 m2 Receives: Device: Holter |
| IgAN with GFR < 15ml/min/1.73 m2 | Experimental | Measure of ANS by holter device in IgAN patients with GFR < 15ml/min/1.73 m2. Receives: Device: Holter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Standard deviation of all R-R intervals (SDNN)
Comparison of Standard deviation of all R-R intervals (SDNN) between GFR category of IgNA
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2015 (estimated)
- Study startJan 2011
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IGA GlomerulonephritisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric Alamartine, PhD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02527902
- Sponsor's protocol ID
- 1008123
- Status last verified
- Aug 2015
- First submitted
- 18 Aug 2015
- Last updated
- 19 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autonomic Nervous System (ANS) Analysis According to Different Renal Function Stage in Immunoglobin A (IgA) Nephropathy
- ClinicalTrials.gov ID
- NCT02527902
- Acronym / sponsor ID
- 1008123
- Conditions
- IGA Glomerulonephritis
- Keywords
- IGA Glomerulonephritis, Autonomic nervous system, ANS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 19 Aug 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 estimation of the cardiovascular risk in the general population must take into account small renal disturbances, as the microalbuminuria. Conversely certain parameters of the cardiovascular risk influence the evolution of renal diseases, for example the arterial high blood pressure.
The measure of the activity of the autonomous nervous system, and especially the quantification of its variability, is a means to estimate the cardiovascular risk. The investigators formulate the hypothesis that the variability of the autonomous nervous system is an additional clinical element for the evaluation of the evolutionary risk of renal diseases.
The aim of this study is to compare the variability of the autonomous nervous system during the various evolutionary stages of the renal disease.
The renal disease studied will be IgA nephropathy (IgNA). IgNA is a histologically defined glomerulonephritis (rela biopsy) by the presence of deposits immunoglobulin A (IgA) in the renal mesangium (at list 1+) by immunofluorescence.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| IgAN with glomerular filtration rate (GFR) >90 ml/min/1.73 m2 | Experimental | Device: HolterMeasure of ANS by holter device in IgAN patients with glomerular filtration rate (GFR) >90 ml/min/1.73 m2 |
| IgAN with GFR 60-89 ml/min/1.73 m2 | Experimental | Device: HolterMeasure of ANS by holter device in IgAN patients with GFR 60-89 ml/min/1.73 m2 |
| IgAN with GFR 30-59 ml/min/1.73 m2 | Experimental | Device: HolterMeasure of ANS by holter device in IgAN patients with GFR 30-59 ml/min/1.73 m2 |
| IgAN with GFR 15-29 ml/min/1.73 m2 | Experimental | Device: HolterMeasure of ANS by holter device in IgAN patients with GFR 15-29 ml/min/1.73 m2 |
| IgAN with GFR < 15ml/min/1.73 m2 | Experimental | Device: HolterMeasure of ANS by holter device in IgAN patients with GFR < 15ml/min/1.73 m2. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- diagnosis of IgNA biopsy-proven free, informed, express and written
Key exclusion criteria (5 listed)
- IgNA secondary to Henoch-Schonlein purpura (HSP) or Systemic Lupus Erythematosus or alcoholic cirrhosis
- current kidney transplantation
- Hypertension treated or not,
- Diseases interfering with ANS analysis: cardiac arrhythmia, beta-blocker therapy
- diabetes
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 |
|---|---|---|
| Holtermeasure of ANS in IgAN patients | Device | IgAN with GFR 15-29 ml/min/1.73 m2, IgAN with GFR 30-59 ml/min/1.73 m2, IgAN with GFR 60-89 ml/min/1.73 m2, IgAN with GFR < 15ml/min/1.73 m2, IgAN with glomerular filtration rate (GFR) >90 ml/min/1.73 m2 |
Primary outcome
Standard deviation of all R-R intervals (SDNN)
Time frame: day 1
Comparison of Standard deviation of all R-R intervals (SDNN) between GFR category of IgNA
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 19 Aug 2015.
Related trials for IGA Glomerulonephritis
RecruitingPhase 2
A Study of JADE101 in Participants With Immunoglobulin A Nephropathy
IgA Nephropathy
Not yet recruitingPhase 3
A Phase 3 Blinded Study of JADE101 in Participants With Immunoglobulin A Nephropathy
IgA Nephropathy (IgAN)
Active, not recruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Sefaxersen (RO7434656) in Participants With Primary Immunoglobulin A (IgA) Nephropathy at High Risk of Progression
Primary IgA Nephropathy
Not yet recruiting
MYTP01 for Immune-Mediated Diseases
IgA Nephropathy, Kidney Transplant Recipients
RecruitingPhase 2
A Study to Evaluate the Effect of ARGX-121 on the Change in Proteinuria in Adult Participants With IgAN
Immunoglobulin A Nephropathy (IgAN)
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.
Eric Alamartine, PhD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Holter in people with IGA Glomerulonephritis, run by Centre Hospitalier Universitaire de Saint Etienne 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 1 inclusion and 5 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 19 Aug 2015. 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?
Standard deviation of all R-R intervals (SDNN) (time frame: day 1). 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 19 Aug 2015.