IgA Nephropathy Severity in Kidney TransplantationICONENCT05234463
Study of the Link Between Complement Activation and IgA Nephropathy Severity
An observational study of IgA Nephropathy Severity in Kidney Transplantation, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
ICONE study (IgA Complement and NEphropathy is a prospective monocentric observational study. The main objective is to evaluate the relevance of complement activation as a biomarker of disease severity and progression in patients with a biopsy proven IgAN. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- IgA Nephropathy Severity in Kidney Transplantation
- What is being tested?
- IgAN patients
- How many people
- 400 participants
- Where
- 1 siteFrance
- Study dates
- 9 May 2022to 1 May 2027
- 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: Adult patients with a histologically proven diagnosis of IgA nephropathy, with or without kidney transplantation history followed in the Nephrology Department of Strasbourg University Hospital.
Who may be able to join
- Adult patients, male or female, with a biopsy proven IgA nephropathy.
- Primitive and secondary forms can be included
- Regardless of the date of diagnosis and the level of kidney function
- With or without past of kidney transplantation
- Followed in the Nephrology Department, Strasbourg University Hospital
- Signed informed consent
Who cannot join
- Active or recent infectious or inflammatory syndrome (<2 months), recent vaccination (<2 months), ongoing acute humoral rejection treatment, treatment with plasma exchanges (<2 months), current treatment with complement inhibitors
- Impossibility of giving informed information (emergency situation, difficulties in understanding, etc.)
- Subject under safeguard of justice, guardianship or curatorship
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Service de néphrologie
Strasbourg
Sophie Caillard, MD
About this study
ICONE study (IgA Complement and NEphropathy is a prospective monocentric observational study.
The main objective is to evaluate the relevance of complement activation as a biomarker of disease severity and progression in patients with a biopsy proven IgAN.
Read the detailed description
IgA nephropathy (IgAN) is a common cause of glomerulonephritis and a major cause of end stage renal disease in up to 20-40% of patients. However, its prognosis still cannot be accurately predicted due to the high heterogenicity of clinical presentations and courses. Complement dysregulation is a main driver of glomerular damages in many glomerulonephritis. Given the growing body of evidence of complement lectin/alternative pathways activation in IgAN pathogenesis, the investigators propose the evaluation of a combination of biomarkers of infra-clinical complement activation to stratify the risk of disease's progression. This study aims to identify subsets of patients in whom complement activation plays a critical role in disease progression. This is of particular interest in the aera of emergence of complement-targeting therapies in IgAN
- Being tested
- IgAN patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IgAN patientsOther
Adult patients Histologically proven diagnosis of IgA nephropathy Primary and secondary forms of the disease With or without kidney transplantation history Regardless of kidney/graft function Patients followed in the Nephrology Department of Strasbourg University Hospital.
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of a severe form of IgA nephropathy
Occurrence of a severe form of IgA nephropathy, with at least one of the following severity criteria: i) a rapid decline in estimated glomerular filtration rate the incidence of end stage kidney disease, iii) the presence of malignant hypertension or thrombotic microangiopathy features, iv) histological endo and/or extra capillary proliferation (E1 and/or C1 according to Oxford 2016 MEST-C score).
Infra-clinical complement activation is defined as a sC5b-9 > 300ng/mL in plasma or a positive ex vivo complement activation functional test on endothelial cells.
Measured: At inclusion
Incidence of a severe form of IgA nephropathy
Occurrence of a severe form of IgA nephropathy, with at least one of the following severity criteria: i) a rapid decline in estimated glomerular filtration rate the presence of malignant hypertension or thrombotic microangiopathy features, iv) histological endo and/or extra capillary proliferation (E1 and/or C1 according to Oxford 2016 MEST-C score).
Measured: 1 year after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2022
- Study start9 May 2022
- Primary completion1 May 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for IgA Nephropathy Severity in Kidney TransplantationStudies 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
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05234463
- Sponsor's protocol ID
- 8361
- Acronym
- ICONE
- Status last verified
- Aug 2026
- First submitted
- 31 Jan 2022
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Duval A, Maillard N, Morin M, El Sissy C, Vieira-Martins P, Durand A, Roquigny J, Lecerf M, Chauvet S, Olagne J, Moulin B, Roumenina L, Limou S, Mariat C, Caillard S, Fremeaux-Bacchi V. Association of Complement Genetics with Outcomes in IgA Nephropathy. Clin J Am Soc Nephrol. 2026 Jul 1;21(7):1207-1221. doi: 10.2215/CJN.0000001062. Epub 2026 May 15.
PubMed 42138996
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Link Between Complement Activation and IgA Nephropathy Severity
- ClinicalTrials.gov ID
- NCT05234463
- Acronym / sponsor ID
- ICONE / 8361
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 9 May 2022 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 10 Feb 2022 (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.
ICONE study (IgA Complement and NEphropathy is a prospective monocentric observational study.
The main objective is to evaluate the relevance of complement activation as a biomarker of disease severity and progression in patients with a biopsy proven IgAN.
Detailed description
IgA nephropathy (IgAN) is a common cause of glomerulonephritis and a major cause of end stage renal disease in up to 20-40% of patients. However, its prognosis still cannot be accurately predicted due to the high heterogenicity of clinical presentations and courses. Complement dysregulation is a main driver of glomerular damages in many glomerulonephritis. Given the growing body of evidence of complement lectin/alternative pathways activation in IgAN pathogenesis, the investigators propose the evaluation of a combination of biomarkers of infra-clinical complement activation to stratify the risk of disease's progression. This study aims to identify subsets of patients in whom complement activation plays a critical role in disease progression. This is of particular interest in the aera of emergence of complement-targeting therapies in IgAN
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with a histologically proven diagnosis of IgA nephropathy, with or without kidney transplantation history followed in the Nephrology Department of Strasbourg University Hospital.
Key inclusion criteria (6 listed)
- Adult patients, male or female, with a biopsy proven IgA nephropathy.
- Primitive and secondary forms can be included
- Regardless of the date of diagnosis and the level of kidney function
- With or without past of kidney transplantation
- Followed in the Nephrology Department, Strasbourg University Hospital
Key exclusion criteria (3 listed)
- Active or recent infectious or inflammatory syndrome (<2 months), recent vaccination (<2 months), ongoing acute humoral rejection treatment, treatment with plasma exchanges (<2 months), current treatment with complement inhibitors
- Impossibility of giving informed information (emergency situation, difficulties in understanding, etc.)
- Subject under safeguard of justice, guardianship or curatorship
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 |
|---|---|---|
| IgAN patientsAdult patients Histologically proven diagnosis of IgA nephropathy Primary and secondary forms of the disease With or without kidney transplantation history Regardless of kidney/graft function Patients followed in the Nephrology Department of Strasbourg University Hospital. | Other | – |
Primary outcome
Incidence of a severe form of IgA nephropathy
Time frame: At inclusion
Occurrence of a severe form of IgA nephropathy, with at least one of the following severity criteria: i) a rapid decline in estimated glomerular filtration rate the incidence of end stage kidney disease, iii) the presence of malignant hypertension or thrombotic microangiopathy features, iv) histological endo and/or extra capillary proliferation (E1 and/or C1 according to Oxford 2016 MEST-C score). Infra-clinical complement activation is defined as a sC5b-9 > 300ng/mL in plasma or a positive ex vivo complement activation functional test on endothelial cells.
Incidence of a severe form of IgA nephropathy
Time frame: 1 year after inclusion
Occurrence of a severe form of IgA nephropathy, with at least one of the following severity criteria: i) a rapid decline in estimated glomerular filtration rate the presence of malignant hypertension or thrombotic microangiopathy features, iv) histological endo and/or extra capillary proliferation (E1 and/or C1 according to Oxford 2016 MEST-C score).
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 19 Aug 2026.
- Derived from this study: PubMed 42138996Duval A, Maillard N, Morin M, El Sissy C, Vieira-Martins P, Durand A, Roquigny J, Lecerf M, Chauvet S, Olagne J, Moulin B, Roumenina L, Limou S, Mariat C, Caillard S, Fremeaux-Bacchi V. Association of Complement Genetics with Outcomes in IgA Nephropathy. Clin J Am Soc Nephrol. 2026 Jul 1;21(7):1207-1221. doi: 10.2215/CJN.0000001062. Epub 2026 May 15.
- Individual participant dataSharing planned: No
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 IgA Nephropathy Severity in Kidney Transplantation, run by University Hospital, Strasbourg, France 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 6 inclusion and 3 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 19 Aug 2026. 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?
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 Sophie Ohlmann- Caillard, MD (03.88.11.67.68, sophie.ohlmann@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of a severe form of IgA nephropathy (time frame: At inclusion). The study lists 2 primary outcomes in all. 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 NCT05234463, which also lists 1 linked publication.
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 2026; AzTrials last refreshed its copy on 1 Nov 2026.