Anti-Glomerular Basement Membrane DiseasePRAGMATICNCT07018024
Anti-Glomerular Basement Membrane Disease
An observational study of Anti-Glomerular Basement Membrane Disease, run by Region Skane at 1 site in Sweden.
Trial summary
This study aims to clarify the prognosis of the rare but severe condition anti-glomerular basement membrane disease (anti-GBM disease also known as Goodpastures disease). Specifically, the aim is to investigate how the prognosis is affected by treatment options and disease severity at presentation measured using… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anti-Glomerular Basement Membrane Disease
- How many people
- 300 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jan 2024to Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Patients treated for anti-GBM disease at one of the participating centers
Who may be able to join
- Anti-GBM disease diagnosed 01-01-2010 - 31-12-2027
- Available information about initial treatment
- Arm B:
- Anti-GBM disease diagnosis (no time limit)
- Available blood and/or urine sample at the time of diagnosis
- Available information about patient survival at six months
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Lund
Lund
Mårten Segelmark, +46702871990, marten.segelmark@med.lu.se
About this study
Official title: Prognosis of Anti-GBM Antibody Disease Through an International Cohort
This study aims to clarify the prognosis of the rare but severe condition anti-glomerular basement membrane disease (anti-GBM disease also known as Goodpastures disease). Specifically, the aim is to investigate how the prognosis is affected by treatment options and disease severity at presentation measured using biomarkers in blood and urine. The study has two arms, one focusing on treatment (A) and one focusing on biomarkers (B). Data from a research subject (patient) can be included in both arms. For inclusion in arm A patients must be diagnosed after 01-01-2010 with available information about treatment and the participating clinic must have a search strategy enabling inclusion of > 80% of their patients. For inclusion in arm B there is no time limit, but there must be blood and/or urine samples available from the time of diagnosis and information about if the patient was alive six months after diagnosis.
Due to the rarity of anti-GBM disease, very few clinical trials have been conducted. Instead, available information comes from observational studies, most of which are relatively small and/or includes patients treated during the previous millennium, sometimes with sparse information about treatment. With this study we aim to collect more information about initial treatment. Today, treatment is based on three pharmaceutical groups; corticosteroids, cytotoxic agents and plasma exchange. Presently available data indicates that all three groups are needed, but all three can be used with variations in administration and intensity. At this time, it is not clear how intense the treatment needs to be, while it is clear that an intense treatment increases the risk of infections.
At present, two factors seem to be able to predict the possibility to preserve kidney function; kidney function at diagnosis measured as plasma creatinine concentration and the degree of kidney damage measured as the proportion of healthy renal corpuscles (glomeruli) in a tissue sample (biopsy). There is also data indicating that the amount of anti-GBM autoantibodies is prognostic, but this is less clear. In recent years, several other types of autoantibodies such as anti-laminin and anti-myeloperoxidase has been proposed to affect prognosis, but their importance remains unclear. Likewise, autoantibody characteristics such as subclass and exact binding site, can be evaluated, but the clinical significance of this is not known. This is also the case for markers of inflammation and renal damage in blood and urine.
- Medical subject headings
- Anti-Glomerular Basement Membrane Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Patients diagnosed with anti-GBM disease 01-01-2010 until 31-12-2027 with available data about treatment | |
| Arm B | Patients diagnosed with anti-GBM disease, no time limit, with available blood and/or urine sample at time of diagnosis and information about if the patient was alive 6 months after treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Renal survival at 12 months
Measured as dialysis dependence
Measured: 12 months after diagnosis
Secondary outcomes (2)
Patient survival at six months
Measured: 6 months after diagnosis
Patient survival at 12 months
Measured: 12 months after diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2025
- Study start1 Jan 2024
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anti-Glomerular Basement Membrane DiseaseStudies 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
- Other
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Collaborators
- Lund University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07018024
- Sponsor's protocol ID
- 2023-05525-01
- Other IDs
- 2023
- Acronym
- PRAGMATIC
- Status last verified
- Apr 2025
- First submitted
- 4 Jun 2025
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared due to the ethical regulations in Sweden. However, upon reasonable request to the study coordinators, selected anonymized data and/or data on group level might be shared.
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognosis of Anti-GBM Antibody Disease Through an International Cohort
- ClinicalTrials.gov ID
- NCT07018024
- Acronym / sponsor ID
- PRAGMATIC / 2023-05525-01
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Collaborators
- Lund University
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 12 Jun 2025 (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 aims to clarify the prognosis of the rare but severe condition anti-glomerular basement membrane disease (anti-GBM disease also known as Goodpastures disease). Specifically, the aim is to investigate how the prognosis is affected by treatment options and disease severity at presentation measured using biomarkers in blood and urine. The study has two arms, one focusing on treatment (A) and one focusing on biomarkers (B). Data from a research subject (patient) can be included in both arms. For inclusion in arm A patients must be diagnosed after 01-01-2010 with available information about treatment and the participating clinic must have a search strategy enabling inclusion of > 80% of their patients. For inclusion in arm B there is no time limit, but there must be blood and/or urine samples available from the time of diagnosis and information about if the patient was alive six months after diagnosis.
Due to the rarity of anti-GBM disease, very few clinical trials have been conducted. Instead, available information comes from observational studies, most of which are relatively small and/or includes patients treated during the previous millennium, sometimes with sparse information about treatment. With this study we aim to collect more information about initial treatment. Today, treatment is based on three pharmaceutical groups; corticosteroids, cytotoxic agents and plasma exchange. Presently available data indicates that all three groups are needed, but all three can be used with variations in administration and intensity. At this time, it is not clear how intense the treatment needs to be, while it is clear that an intense treatment increases the risk of infections.
At present, two factors seem to be able to predict the possibility to preserve kidney function; kidney function at diagnosis measured as plasma creatinine concentration and the degree of kidney damage measured as the proportion of healthy renal corpuscles (glomeruli) in a tissue sample (biopsy). There is also data indicating that the amount of anti-GBM autoantibodies is prognostic, but this is less clear. In recent years, several other types of autoantibodies such as anti-laminin and anti-myeloperoxidase has been proposed to affect prognosis, but their importance remains unclear. Likewise, autoantibody characteristics such as subclass and exact binding site, can be evaluated, but the clinical significance of this is not known. This is also the case for markers of inflammation and renal damage in blood and urine.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | – | –Patients diagnosed with anti-GBM disease 01-01-2010 until 31-12-2027 with available data about treatment |
| Arm B | – | –Patients diagnosed with anti-GBM disease, no time limit, with available blood and/or urine sample at time of diagnosis and information about if the patient was alive 6 months after treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated for anti-GBM disease at one of the participating centers
Key inclusion criteria (6 listed)
- Anti-GBM disease diagnosed 01-01-2010 - 31-12-2027
- Available information about initial treatment
- Anti-GBM disease diagnosis (no time limit)
- Available blood and/or urine sample at the time of diagnosis
- Available information about patient survival at six months
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.
Primary outcome
Renal survival at 12 months
Time frame: 12 months after diagnosis
Measured as dialysis dependence
2 secondary outcomes
Patient survival at six months
Time frame: 6 months after diagnosis
Patient survival at 12 months
Time frame: 12 months after diagnosis
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2025.
- Individual participant dataSharing planned: No. IPD will not be shared due to the ethical regulations in Sweden. However, upon reasonable request to the study coordinators, selected anonymized data and/or data on group level might be shared.
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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.
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 Anti-Glomerular Basement Membrane Disease, run by Region Skane at 1 site in Sweden.
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 6 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: looking for participants now, as of the sponsor's last update on 25 Jun 2025. 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 Sweden. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mårten Segelmark, MD, PhD, Professor (+46702871990, marten.segelmark@med.lu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Renal survival at 12 months (time frame: 12 months after diagnosis). 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 25 Jun 2025.