IgA NephropathyNCT03488368
Longterm Renal Oucomes of STOP-IgAN Trial Participants
An observational study of IgA Nephropathy, run by RWTH Aachen University at 1 site in Germany.
Trial summary
IgA nephropathy (IgAN) is the most prevalent form of primary glomerulonephritis in the Western world. Although most IgAN patients take a benign longterm course, about 20-30% progress to end-stage renal disease (ESRD) over 20 years. The majority of current treatment recommendations is based on weak evidence. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- IgA Nephropathy
- What is being tested?
- observation
- How many people
- 148 participants
- Where
- 1 siteGermany
- Study dates
- 1 Feb 2018to 31 Dec 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All randomized STOP-IgAN participants with the exception of drop-outs.
Who may be able to join
- All randomized STOP-IgAN participants.
Who cannot join
- Drop-outs of the main STOP-IgAN trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Quality Control of STOP-IgAN Trial Results in Longterm Observation With Existing Routine Data of Randomized Trial Participants (STOP-IgAN - Longterm) - Observational Study
IgA nephropathy (IgAN) is the most prevalent form of primary glomerulonephritis in the Western world. Although most IgAN patients take a benign longterm course, about 20-30% progress to end-stage renal disease (ESRD) over 20 years. The majority of current treatment recommendations is based on weak evidence.
In the randomized, controlled Supportive Versus Immunosuppressive Therapy for the Treatment Of Progressive IgAN (STOP-IgAN) trial, the investigators analyzed whether additional immunosuppression on top of standardized supportive care provides renal benefits in patients with progressive IgAN. Patients with persisting proteinuria >0.75 g/d (n=162) despite optimized supportive treatment including control of blood pressure and proteinuria, were randomized to either continue on supportive care or to receive additional immunosuppression during the 3-year trial phase. It was observed that immunosuppressive therapy in addition to optimized supportive care led to more full clinical remissions, but eventually did not better preserve renal function, did not better save patients from ESRD development and evoked more adverse effects such as infections, weight gain and diabetes.
Read more
Aim of this planned study is to analyze renal outcome measures and adverse effects in the longterm observation of all randomized STOP-IgAN participants to ascertain quality and strength of the original trial results. By its observational nature, this quality control study includes the 162 IgAN patients (with the exception of drop-out patients) that had been previously randomized into the original STOP-IgAN trial.
Information on serum creatinine, proteinuria, ESRD, death, relevant adverse events such as major cardiovascular events, osteoporosis, osteonecrosis, bone fractures, diabetes, malignancies and interim treatment will be collected as available from existing routine records until March 31, 2018.
Primary endpoint is the time to the first occurring event of the binary composite of all-cause death, ESRD or decline in estimated glomerular filtration rate (eGFR) by at least 40% as compared to enrollment into the original trial. Secondary outcome measures comprise the individual components of the primary endpoint, absolute eGFR at the end of observation, proteinuria and adverse events. Information on specific treatments with renin-angiotensin-system (RAS)-blocking agents and/or interim immunosuppression will also be collected. All data will be recorded in a pseudonymous fashion in a central electronic data base located at the PI's site.
Read the detailed description
Aim: Observational quality control study to analyze renal outcome measures and adverse events in the longterm observation of all randomized STOP-IgAN participants to ascertain quality and strength of the original trial results.
Eligible subjects/sample size: By its observational nature, this study includes the 162 IgAN patients (with the exception of drop-out patients) that had been previously randomized into the original STOP-IgAN trial. Since this study is performed as quality control study of previously randomized patients, a new written informed consent is not necessary.
Endpoints: Primary endpoint is the time to the first occurring event of the binary composite of all-cause death, ESRD or decline in estimated glomerular filtration rate (eGFR) by at least 40% as compared to enrollment into the original trial (time-to-event analysis). Secondary outcome measures comprise the individual components of the primary endpoint, absolute eGFR at the end of observation, proteinuria and adverse events. Information on specific treatments with renin-angiotensin-system (RAS)-blocking agents and/or interim immunosuppression will also be collected.
Data collection: Available information on serum creatinine, proteinuria, ESRD, death, relevant adverse events such as major cardiovascular events, osteoporosis, osteonecrosis, bone fractures, diabetes, malignancies and interim treatment will be collected retrospectively as available from existing nephrology routine records until March 31, 2018. The involved nephrology departments (all in Germany) will be contacted by phone and asked to provide these informations from the randomized STOP-IgAN patients. All data will be recorded in a pseudonymous fashion in a central electronic data base located at the PI's site. To assure high-standard data quality, source data entry will be performed in a double-entry mode, i.e. each data point will be entered independently by two individuals.
- Conditions
- IgA Nephropathy
- Being tested
- observation
- Medical subject headings
- Glomerulonephritis, IGA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observationOther
Observation of renal outcome parameters and adverse events in the follow-up beyond the 3-year trial phase of the original STOP-IgAN trial.
| Study group | Role | What they receive |
|---|---|---|
| Supportive-care group | Observation of IgAN patients who received supportive care measures (without additional immunosuppression) during the first three years after randomization, i.e. trial phase of the original STOP-IgAN trial. Receives: Other: observation | |
| Immunosuppression group | Observation of IgAN patients who received supportive care measures and additional immunosuppression during the first three years after randomization, i.e. trial phase of the original STOP-IgAN trial. Receives: Other: observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to the first occurring event of the binary composite of all-cause death, end-stage renal disease (ESRD) and of estimated glomerular filtration rate (eGFR)-loss >40% based on available data by March 31, 2018.
Time to the first occurring event of the binary composite of all-cause death, end-stage renal disease (ESRD) and of estimated glomerular filtration rate (eGFR)-loss >40% based on available data by March 31, 2018. For GFR-loss, we consider eGFR values baseline (enrolment into original STOP-IgAN trial) and the last two available values by March 31, 2018. For GFR-loss, eGFR will be calculated using the creatinine-based, formula of Chronic Kidney Disease Epidemiology Collaboration (CKD-Epi). Data will be considered at baseline, 6 months, 12 months, 24 months and 36 months after randomization and the last two available values by March 31, 2018.
Measured: as available by March 31, 2018
Secondary outcomes (6)
all-cause death
death by any cause.
Measured: as available by March 31, 2018
end-stage renal disease (ESRD)
date of first occurrence of ESRD, i.e. initiation of regular dialysis therapy or renal transplant
Measured: as available by March 31, 2018
first occurrence of eGFR-loss > 40%
Values will be considered of the first three years after randomization and the last two available values by March 31, 2018.
Measured: as available by March 31, 2018
first occurrence of eGFR-loss > 30%
Values will be considered of the first three years after randomization and the last two available values by March 31, 2018.
Measured: as available by March 31, 2018
course of proteinuria
Values will be considered of the first three years after randomization and the last two available values by March 31, 2018.
Measured: as available by March 31, 2018
Occurrence of major adverse cardiovascular events (MACE) and other relevant adverse events
MACE included one of the following events: cardiovascular death, myocardial infarction, transient ischemic attack (TIA), stroke, peripheral vascular event.
Other relevant side effects include diabetes mellitus, osteoporosis, osteonecrosis, bone fracture, malignancy.
Measured: as available by March 31, 2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2018
- Study start1 Feb 2018
- Primary completion31 Jul 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jürgen Floege, RWTH Aachen University
- Investigators
- Juergen Floege, MD, Principal investigator, RWTH Aachen University, University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03488368
- Sponsor's protocol ID
- STOP IgAN - Longterm
- Status last verified
- Mar 2019
- First submitted
- 28 Mar 2018
- Last updated
- 26 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rauen T, Eitner F, Fitzner C, Sommerer C, Zeier M, Otte B, Panzer U, Peters H, Benck U, Mertens PR, Kuhlmann U, Witzke O, Gross O, Vielhauer V, Mann JF, Hilgers RD, Floege J; STOP-IgAN Investigators. Intensive Supportive Care plus Immunosuppression in IgA Nephropathy. N Engl J Med. 2015 Dec 3;373(23):2225-36. doi: 10.1056/NEJMoa1415463.
PubMed 26630142Howie AJ, Lalayiannis AD. The Oxford Classification Should Remain the Gold Standard for Classification of IgA Nephropathy: CON. Kidney360. 2026 Oct 1;7(10):2382-2384. doi: 10.34067/KID.0000001083. Epub 2026 Feb 9. No abstract available.
PubMed 41661687
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality Control of STOP-IgAN Trial Results in Longterm Observation With Existing Routine Data of Randomized Trial Participants (STOP-IgAN - Longterm) - Observational Study
- ClinicalTrials.gov ID
- NCT03488368
- Acronym / sponsor ID
- STOP IgAN - Longterm
- Conditions
- IgA Nephropathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 31 Jul 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 5 Apr 2018 (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.
IgA nephropathy (IgAN) is the most prevalent form of primary glomerulonephritis in the Western world. Although most IgAN patients take a benign longterm course, about 20-30% progress to end-stage renal disease (ESRD) over 20 years. The majority of current treatment recommendations is based on weak evidence.
In the randomized, controlled Supportive Versus Immunosuppressive Therapy for the Treatment Of Progressive IgAN (STOP-IgAN) trial, the investigators analyzed whether additional immunosuppression on top of standardized supportive care provides renal benefits in patients with progressive IgAN. Patients with persisting proteinuria >0.75 g/d (n=162) despite optimized supportive treatment including control of blood pressure and proteinuria, were randomized to either continue on supportive care or to receive additional immunosuppression during the 3-year trial phase. It was observed that immunosuppressive therapy in addition to optimized supportive care led to more full clinical remissions, but eventually did not better preserve renal function, did not better save patients from ESRD development and evoked more adverse effects such as infections, weight gain and diabetes.
Aim of this planned study is to analyze renal outcome measures and adverse effects in the longterm observation of all randomized STOP-IgAN participants to ascertain quality and strength of the original trial results. By its observational nature, this quality control study includes the 162 IgAN patients (with the exception of drop-out patients) that had been previously randomized into the original STOP-IgAN trial.
Information on serum creatinine, proteinuria, ESRD, death, relevant adverse events such as major cardiovascular events, osteoporosis, osteonecrosis, bone fractures, diabetes, malignancies and interim treatment will be collected as available from existing routine records until March 31, 2018.
Primary endpoint is the time to the first occurring event of the binary composite of all-cause death, ESRD or decline in estimated glomerular filtration rate (eGFR) by at least 40% as compared to enrollment into the original trial. Secondary outcome measures comprise the individual components of the primary endpoint, absolute eGFR at the end of observation, proteinuria and adverse events. Information on specific treatments with renin-angiotensin-system (RAS)-blocking agents and/or interim immunosuppression will also be collected. All data will be recorded in a pseudonymous fashion in a central electronic data base located at the PI's site.
Detailed description
Aim: Observational quality control study to analyze renal outcome measures and adverse events in the longterm observation of all randomized STOP-IgAN participants to ascertain quality and strength of the original trial results.
Eligible subjects/sample size: By its observational nature, this study includes the 162 IgAN patients (with the exception of drop-out patients) that had been previously randomized into the original STOP-IgAN trial. Since this study is performed as quality control study of previously randomized patients, a new written informed consent is not necessary.
Endpoints: Primary endpoint is the time to the first occurring event of the binary composite of all-cause death, ESRD or decline in estimated glomerular filtration rate (eGFR) by at least 40% as compared to enrollment into the original trial (time-to-event analysis). Secondary outcome measures comprise the individual components of the primary endpoint, absolute eGFR at the end of observation, proteinuria and adverse events. Information on specific treatments with renin-angiotensin-system (RAS)-blocking agents and/or interim immunosuppression will also be collected.
Data collection: Available information on serum creatinine, proteinuria, ESRD, death, relevant adverse events such as major cardiovascular events, osteoporosis, osteonecrosis, bone fractures, diabetes, malignancies and interim treatment will be collected retrospectively as available from existing nephrology routine records until March 31, 2018. The involved nephrology departments (all in Germany) will be contacted by phone and asked to provide these informations from the randomized STOP-IgAN patients. All data will be recorded in a pseudonymous fashion in a central electronic data base located at the PI's site. To assure high-standard data quality, source data entry will be performed in a double-entry mode, i.e. each data point will be entered independently by two individuals.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supportive-care group | – | Other: observationObservation of IgAN patients who received supportive care measures (without additional immunosuppression) during the first three years after randomization, i.e. trial phase of the original STOP-IgAN trial. |
| Immunosuppression group | – | Other: observationObservation of IgAN patients who received supportive care measures and additional immunosuppression during the first three years after randomization, i.e. trial phase of the original STOP-IgAN trial. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All randomized STOP-IgAN participants with the exception of drop-outs.
Key inclusion criteria (1 listed)
- All randomized STOP-IgAN participants.
Key exclusion criteria (1 listed)
- Drop-outs of the main STOP-IgAN trial.
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 |
|---|---|---|
| observationObservation of renal outcome parameters and adverse events in the follow-up beyond the 3-year trial phase of the original STOP-IgAN trial. | Other | Immunosuppression group, Supportive-care group |
Primary outcome
Time to the first occurring event of the binary composite of all-cause death, end-stage renal disease (ESRD) and of estimated glomerular filtration rate (eGFR)-loss >40% based on available data by March 31, 2018.
Time frame: as available by March 31, 2018
Time to the first occurring event of the binary composite of all-cause death, end-stage renal disease (ESRD) and of estimated glomerular filtration rate (eGFR)-loss >40% based on available data by March 31, 2018. For GFR-loss, we consider eGFR values baseline (enrolment into original STOP-IgAN trial) and the last two available values by March 31, 2018. For GFR-loss, eGFR will be calculated using the creatinine-based, formula of Chronic Kidney Disease Epidemiology Collaboration (CKD-Epi). Data will be considered at baseline, 6 months, 12 months, 24 months and 36 months after randomization and the last two available values by March 31, 2018.
6 secondary outcomes
all-cause death
Time frame: as available by March 31, 2018
end-stage renal disease (ESRD)
Time frame: as available by March 31, 2018
first occurrence of eGFR-loss > 40%
Time frame: as available by March 31, 2018
first occurrence of eGFR-loss > 30%
Time frame: as available by March 31, 2018
course of proteinuria
Time frame: as available by March 31, 2018
Occurrence of major adverse cardiovascular events (MACE) and other relevant adverse events
Time frame: as available by March 31, 2018
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 Mar 2019.
- Results publication: PubMed 26630142Rauen T, Eitner F, Fitzner C, Sommerer C, Zeier M, Otte B, Panzer U, Peters H, Benck U, Mertens PR, Kuhlmann U, Witzke O, Gross O, Vielhauer V, Mann JF, Hilgers RD, Floege J; STOP-IgAN Investigators. Intensive Supportive Care plus Immunosuppression in IgA Nephropathy. N Engl J Med. 2015 Dec 3;373(23):2225-36. doi: 10.1056/NEJMoa1415463.
- Derived from this study: PubMed 41661687Howie AJ, Lalayiannis AD. The Oxford Classification Should Remain the Gold Standard for Classification of IgA Nephropathy: CON. Kidney360. 2026 Oct 1;7(10):2382-2384. doi: 10.34067/KID.0000001083. Epub 2026 Feb 9. No abstract available.
- Individual participant dataSharing planned: No
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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.
Juergen Floege, MD principal investigator
RWTH Aachen University, University Hospital
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, run by RWTH Aachen University at 1 site in Germany.
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 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 Mar 2019. 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 Germany. 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?
Time to the first occurring event of the binary composite of all-cause death, end-stage renal disease (ESRD) and of estimated glomerular filtration rate (eGFR)-loss >40% based on available data by March 31, 2018. (time frame: as available by March 31, 2018). 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 NCT03488368, which also lists 2 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 26 Mar 2019.