IgAN - IgA NephropathyNCT07607002
Assessing the Global Burden of IgA Nephropathy (IgAN) in Patients Receiving Hemodialysis: A Real-World Study Using DOPPS Data
An observational study of IgAN - IgA Nephropathy, run by Arbor Research Collaborative for Health.
Trial summary
This study leverages the global Dialysis Outcomes and Practice Patterns Study (DOPPS) database to generate real-world evidence on the burden of IgAN in patients who progress to kidney failure and require maintenance hemodialysis (HD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- IgAN - IgA Nephropathy
- How many people
- 70,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 1996to 31 Dec 2023
- 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
- Adult, Older adult
Study population: This is a retrospective observational study using data from Phases 1 through 7 (1996-2023) of the DOPPS, a multinational, prospective cohort study of in-center HD patients across more than 20 countries. DOPPS collects standardized data on demographics, comorbidities, laboratory values, treatments, hospitalizations, and mortality, as well as many validated PROs. To ensure national representativeness and reduce selection bias, DOPPS uses a stratified random sampling approach to select dialysis facilities and patients within each participating country. Regional representation includes Europe, Japan, North America, China, Oceania, and the Gulf Cooperation Council (GCC).
Who may be able to join
- Age ≥ 18 years at the time of enrollment
- Receiving in-center HD treatment at a participating dialysis facility
- Able to provide informed consent, if required by local regulations or ethics boards
Who cannot join
- -
About this study
This study leverages the global Dialysis Outcomes and Practice Patterns Study (DOPPS) database to generate real-world evidence on the burden of IgAN in patients who progress to kidney failure and require maintenance hemodialysis (HD). We will first aim to understand prevalence of IgAN in a global cohort of in-center HD patients. The second and third objectives aim to quantify the patient burden of IgAN using a two-step approach: first, a detailed single-arm evaluation of outcomes within the IgAN population; second, a matched comparison to the broader HD population.
- Conditions
- IgAN - IgA Nephropathy
- Keywords
- IgAN, Dialysis
- Medical subject headings
- Glomerulonephritis, IGA
What is being measured
The primary outcome is the main question the study is designed to answer.
IgAN
Measured: 1996-2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2026
- Study start1 Jan 1996
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IgAN - IgA NephropathyStudies 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
- Retrospective
- Enrolment
- 70,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arbor Research Collaborative for Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roberto Pecoits-Filho, Arbor Research Collaborative for Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07607002
- Sponsor's protocol ID
- OAK-ISS-2025-002154
- Status last verified
- May 2026
- First submitted
- 19 May 2026
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Global Burden of IgA Nephropathy (IgAN) in Patients Receiving Hemodialysis: A Real-World Study Using DOPPS Data
- ClinicalTrials.gov ID
- NCT07607002
- Acronym / sponsor ID
- OAK-ISS-2025-002154
- Conditions
- IgAN - IgA Nephropathy
- Keywords
- IgAN, Dialysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70,000 participants (actual)
- Lead sponsor
- Arbor Research Collaborative for HealthUniversity, hospital or other
- Study start
- 1 Jan 1996 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 26 May 2026 (actual)
- 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.
This study leverages the global Dialysis Outcomes and Practice Patterns Study (DOPPS) database to generate real-world evidence on the burden of IgAN in patients who progress to kidney failure and require maintenance hemodialysis (HD). We will first aim to understand prevalence of IgAN in a global cohort of in-center HD patients. The second and third objectives aim to quantify the patient burden of IgAN using a two-step approach: first, a detailed single-arm evaluation of outcomes within the IgAN population; second, a matched comparison to the broader HD population.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- This is a retrospective observational study using data from Phases 1 through 7 (1996-2023) of the DOPPS, a multinational, prospective cohort study of in-center HD patients across more than 20 countries. DOPPS collects standardized data on demographics, comorbidities, laboratory values, treatments, hospitalizations, and mortality, as well as many validated PROs. To ensure national representativeness and reduce selection bias, DOPPS uses a stratified random sampling approach to select dialysis facilities and patients within each participating country. Regional representation includes Europe, Japan, North America, China, Oceania, and the Gulf Cooperation Council (GCC).
Key inclusion criteria (3 listed)
- Age ≥ 18 years at the time of enrollment
- Receiving in-center HD treatment at a participating dialysis facility
- Able to provide informed consent, if required by local regulations or ethics boards
Key exclusion criteria (1 listed)
- -
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
IgAN
Time frame: 1996-2023
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 26 May 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of IgAN - IgA Nephropathy, run by Arbor Research Collaborative for Health.
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 3 inclusion and 1 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 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
IgAN (time frame: 1996-2023). 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 26 May 2026.