Plain English Summary
Background and study aims
IgA nephropathy, also known as Berger's disease, is a kidney disease that occurs when an antibody called immunoglobulin A (IgA) builds up in the kidneys. This results in local inflammation that, over time, can hamper the kidneys' ability to filter waste from the blood.
Treatment of IgA nephropathy (IgAN) is a matter of debate and while corticosteroids remain the most effective in preventing disease progression, their use is limited by important side effects. This study aims to evaluate the efficacy of budesonide (Budenofalk®) in the treatment of patients with IgA Nephropathy.
Who can participate?
Patients aged 18 years or above with IgA nephropathy and persistent proteinuria.
What does the study involve?
Patients receive treatment with Budesonide for up to 36 months.
What are the possible benefits and risks of participating?
The benefit include the possibility of being treated and followed in a tertiary clinic, with high experience in managing the patients with IgA Nephropathy. This study doesn’t carry any risk associated with the participation, other than that related to the risk associated with diagnostic procedures (percutaneous kidney biopsy) and the possibility of minimal steroid-related side-effects.
Where is the study run from?
Fundeni Clinical Institute, Department of Nephrology (Romania)
When is the study starting and how long is it expected to run for?
March 2020 to December 2024
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Gener Ismail
gener732000@yahoo.com
Dr Bogdan Obrisca
obriscabogdan@yahoo.com
Trial website
Contact information
Type
Scientific
Primary contact
Dr Gener Ismail
ORCID ID
http://orcid.org/0000-0003-3306-189X
Contact details
Fundeni Clinical Institute
Department of Nephrology
Fundeni Street 258
Bucharest
022328
Romania
+40 722792429
gener732000@yahoo.com
Type
Scientific
Additional contact
Dr Bogdan Obrisca
ORCID ID
http://orcid.org/0000-0003-4796-4950
Contact details
Fundeni Clinical Institute
Department of Nephrology
Fundeni Street 258
Bucharest
022328
Romania
+40 721256797
bogdan.obrisca@drd.umfcd.ro
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
1975
Study information
Scientific title
An open-label study evaluating the efficacy and safety of budesonide in the treatment of patients with immunoglobulin A nephropathy
Acronym
BUDIGAN
Study hypothesis
Gut-associated lymphoid tissue production (GALT) of the immunoglobulin A1 with a characteristic galactosylation defect in the hinge region of the molecule is the first pathogenic event in the course of IgA nephropathy. Targeting GALT dysregulation with a pH-modified formulation of budesonide with a maximum release in the distal ileum and proximal colon offers the premise of a safer approach than systemic corticosteroids for the treatment of IgA nephropathy.
Ethics approval
Approved 18/12/2019, The Ethics Council of Fundeni Clinical Institute (Sos. Fundeni, Nr. 258, Sector 2, Bucharest, 022328, Romania; +40 212750500; etica@icfundeni.ro), ref: 1975
Study design
Prospective interventional open-label single-center non-randomised study
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format. Please use contact details to request a participation information sheet
Condition
Immunoglobulin A nephropathy
Intervention
Patients receive treatment with budesonide at a dose of 9 mg/day for the first 12 months, subsequently tapered to 3 mg/day for another 12-24 months.
Intervention type
Drug
Phase
Phase IV
Drug names
Budesonide (Budenofalk®)
Primary outcome measure
At baseline and 36 months:
1. Estimated glomerular filtration rate
2. Extent of proteinuria and hematuria
3. MESTC score assessed by kidney biopsy
Secondary outcome measures
Incidence of budesonide-related adverse events over the 36 months
Overall trial start date
01/03/2020
Overall trial end date
31/12/2024
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged ≥18 years
2. Patients with a histological diagnosis of IgA nephropathy
3. Patients with primary IgA nephropathy
4. Patients with persistent proteinuria over 1g/day despite adequate renin-angiotensin-aldosterone system (RAAS) blockade or patients with proteinuria between 0.5 and 1 g/day after RAAS blockade if they had additional risk factors for progression (estimated glomerular filtration rate below 60 ml/min/1.73m², presence of proliferative lesions on kidney biopsy)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
30 - 40
Participant exclusion criteria
1. IgAN associated with other disorders (viral infections, autoimmune disorders, malignancy)
2. Estimated glomerular filtration rate below 20 ml/min/1.73m²
4. Nephrotic syndrome or a rapidly progressive clinical course
5. Proteinuria below 0.5 g/day after adequate RAAS blockade.
6. Severe histological lesions of activity or chronicity (endocapillary hypercellularity in over 50% of examined glomeruli, crescents in over 30% of examined glomeruli, presence of fibrinoid necrosis, global glomerulosclerosis in over 50% of examined glomeruli)
7. Diabetes mellitus or active infections
8. Received prior immunosuppression
Recruitment start date
01/03/2020
Recruitment end date
31/12/2022
Locations
Countries of recruitment
Romania
Trial participating centre
Fundeni Clinical Institute
Department of Nephrology
Fundeni Street number 258
Bucharest
022328
Romania
Sponsor information
Organisation
Institutul Clinic Fundeni
Sponsor details
Fundeni Street 258
Bucharest
022328
Romania
+40 213119190
secretariat@icfundeni.ro
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Other
Funder name
Investigator initiated and funded
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned to publish in a high-impact, peer-reviewed journal.
IPD sharing statement:
All data generated or analysed during this study will be included in the subsequent results publication.
Intention to publish date
31/12/2025
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list