IgA NephropathyNCT02529722
Biomarkers for the Progression of IgA Nephropathy
An observational study of IgA Nephropathy and Glomerular Diseases, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
IgA nephropathy (IgAN) is the most prevalent primary glomerular disease worldwide and an important cause of end stage renal disease. IgAN has an incidence of 8-25 new cases/year/per million age-related population in adults and 3-5/new cases/year/per million age-related population in children and progresses to need of… Read more about this study
- Who is it for?
- Ages 16 to 75 years
- Conditions the study is for
- IgA Nephropathy, Glomerular Diseases
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2012to Apr 2015
- How long will I take part?
- 36 Months
- 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 16 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with the diagnosis of biopsy confirmed IgA nephropathy
Who may be able to join
- Patients with biopsy-proven IgA nephropathy (defined by standard criteria)
- Patients at all ages will be included regardless of treatment given
- A renal biopsy available for reviewing must include 8 or more glomeruli.
- At least 3 measurements of blood pressure, serum creatinine and proteinuria have to be performed.
- The first measurement should be within 3 months of the date of renal biopsy and the last at the end of the follow-up.
- Patients must comply with the following criteria
Show all 9Show fewer
- have a follow-up longer than 1 year
- or having progressed to end-stage renal disease regardless of the duration of follow-up.
- Patients who have received antihypertensive or immunosuppressive medication will be included as well.
Who cannot join
- Diabetes at the time of first kidney biopsy.
- Solid organ (other than kidney) or bone marrow transplant at the time of biopsy.
- Other pre-existing parenchymal kidney disease on first kidney biopsy, determined by the pathology examination.
- Diagnosis of any of the following diseases from the time of biopsy to the time of enrollment: Systemic lupus erythematosus, HIV infection, active malignancy, except for non-melanoma skin cancer, active hepatitis B or C infection, defined as positive viral load
- Patients with life expectancy < 6 months
- Patients who are unwilling or unable to consent.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Division of Nephrology, Istanbul Faculty of Medicine, Istanbul University
Istanbul, 34093
About this study
Official title: Histological and Clinical Biomarkers to Predict the Progression of IgA Nephropathy
IgA nephropathy (IgAN) is the most prevalent primary glomerular disease worldwide and an important cause of end stage renal disease. IgAN has an incidence of 8-25 new cases/year/per million age-related population in adults and 3-5/new cases/year/per million age-related population in children and progresses to need of renal replacement treatment in 5-15% at 10 years and in about 20% at 20 years. The variability of the clinical course anticipates different treatment options. There is an absolute need of validated biomarkers to predict risk of progression and indication for treatment at early stages, when lesions can be reversible. This study aimed to evaluate IgAN progression and its histological and clinical correlates.
Read the detailed description
IgA nephropathy is the most prevalent primary glomerular disease worldwide and an important cause of end stage renal disease. Clinical course varies from long term stable renal functions with minimal proteinuria and microscopic hematuria to rapidly progressive glomerulonephritis with crescents on renal biopsy which progresses to end stage renal disease in a very short time.
In current practice the diagnosis is made with renal biopsy. A less invasive procedure for diagnosis is not present and no serum biomarkers for clinical follow-up, treatment response and prognosis are available. For that reason follow-up of the disease is enabled with indirect markers of renal function like proteinuria, serum creatinine and glomerular filtration rate. These markers are not specific for IgA nephropathy. The lack of disease specific markers hinders the standardization of patient follow-up and treatment. Development of specific and sensitive, repeatable, histopathological and clinical markers for diagnosis, follow up and treatment response in IgA nephropathy the most prevalent primary glomerular disease affecting many patients worldwide will offer prospects of diagnosis and improved prognostication.
- Conditions
- IgA Nephropathy, Glomerular Diseases
- Medical subject headings
- Glomerulonephritis, IGA
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression to end stage renal disease or two-fold increase in serum creatinine level as compared to baseline
Measured: 36 months
Secondary outcomes (1)
Resistance of proteinuria
Resistance of proteinuria defined as no improvement in the daily proteinuria levels or >1 g/24 hr proteinuria
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2015 (estimated)
- Study startJan 2012
- Primary completionJan 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IgA NephropathyStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe 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
- 120 participants (actual)
- Target duration
- 36 Months
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasar Caliskan, Istanbul University
- Investigators
- Yasar Caliskan, MD, Principal investigator, Division of Nephrology, Department of Internal Medicine, Istanbul Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02529722
- Sponsor's protocol ID
- 2907
- Status last verified
- Aug 2015
- First submitted
- 7 Aug 2015
- Last updated
- 20 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Histological and Clinical Biomarkers to Predict the Progression of IgA Nephropathy
- ClinicalTrials.gov ID
- NCT02529722
- Acronym / sponsor ID
- 2907
- Conditions
- IgA Nephropathy, Glomerular Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jan 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 20 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.
IgA nephropathy (IgAN) is the most prevalent primary glomerular disease worldwide and an important cause of end stage renal disease. IgAN has an incidence of 8-25 new cases/year/per million age-related population in adults and 3-5/new cases/year/per million age-related population in children and progresses to need of renal replacement treatment in 5-15% at 10 years and in about 20% at 20 years. The variability of the clinical course anticipates different treatment options. There is an absolute need of validated biomarkers to predict risk of progression and indication for treatment at early stages, when lesions can be reversible. This study aimed to evaluate IgAN progression and its histological and clinical correlates.
Detailed description
IgA nephropathy is the most prevalent primary glomerular disease worldwide and an important cause of end stage renal disease. Clinical course varies from long term stable renal functions with minimal proteinuria and microscopic hematuria to rapidly progressive glomerulonephritis with crescents on renal biopsy which progresses to end stage renal disease in a very short time.
In current practice the diagnosis is made with renal biopsy. A less invasive procedure for diagnosis is not present and no serum biomarkers for clinical follow-up, treatment response and prognosis are available. For that reason follow-up of the disease is enabled with indirect markers of renal function like proteinuria, serum creatinine and glomerular filtration rate. These markers are not specific for IgA nephropathy. The lack of disease specific markers hinders the standardization of patient follow-up and treatment. Development of specific and sensitive, repeatable, histopathological and clinical markers for diagnosis, follow up and treatment response in IgA nephropathy the most prevalent primary glomerular disease affecting many patients worldwide will offer prospects of diagnosis and improved prognostication.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 36 Months
Who may qualify
- Ages
- 16 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with the diagnosis of biopsy confirmed IgA nephropathy
Key inclusion criteria (9 listed)
- Patients with biopsy-proven IgA nephropathy (defined by standard criteria)
- Patients at all ages will be included regardless of treatment given
- A renal biopsy available for reviewing must include 8 or more glomeruli.
- At least 3 measurements of blood pressure, serum creatinine and proteinuria have to be performed.
- The first measurement should be within 3 months of the date of renal biopsy and the last at the end of the follow-up.
Key exclusion criteria (6 listed)
- Diabetes at the time of first kidney biopsy.
- Solid organ (other than kidney) or bone marrow transplant at the time of biopsy.
- Other pre-existing parenchymal kidney disease on first kidney biopsy, determined by the pathology examination.
- Diagnosis of any of the following diseases from the time of biopsy to the time of enrollment: Systemic lupus erythematosus, HIV infection, active malignancy, except for non-melanoma skin cancer, active hepatitis B or C infection, defined as positive viral load
- Patients with life expectancy < 6 months
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
Progression to end stage renal disease or two-fold increase in serum creatinine level as compared to baseline
Time frame: 36 months
1 secondary outcome
Resistance of proteinuria
Time frame: 36 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 Aug 2015.
Related trials for IgA Nephropathy
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
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A Study of Mezagitamab in Adults With Kidney Condition Called IgA Nephropathy
Kidney Disease
Not yet recruiting
MYTP01 for Immune-Mediated Diseases
IgA Nephropathy, Kidney Transplant Recipients
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Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of KP104 to Treat Glomerulonephritis
Glomerulonephritis
RecruitingPhase 3
A Phase 3 Blinded Study of JADE101 in Participants With Immunoglobulin A Nephropathy
IgA 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.
Yasar Caliskan, MD principal investigator
Division of Nephrology, Department of Internal Medicine, Istanbul Faculty of Medicine
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 IgA Nephropathy and Glomerular Diseases, run by Istanbul University at 1 site in Turkey (Türkiye).
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 9 inclusion and 6 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 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 Turkey (Türkiye). 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?
Progression to end stage renal disease or two-fold increase in serum creatinine level as compared to baseline (time frame: 36 months). 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 Aug 2015.