Stabilization of kidney function in patients diagnosed with primary immunoglobulin A nephropathy by treatment with a locally-acting corticosteroid formulation – budesonide

ISRCTN ISRCTN47722295
DOI https://doi.org/10.1186/ISRCTN47722295
Secondary identifying numbers 1975
Submission date
12/02/2020
Registration date
14/02/2020
Last edited
20/11/2023
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Dr Gener Ismail
Scientific

Fundeni Clinical Institute
Department of Nephrology
Fundeni Street 258
Bucharest
022328
Romania

ORCiD logoORCID ID 0000-0003-3306-189X
Phone +40 722792429
Email gener732000@yahoo.com
Dr Bogdan Obrisca
Scientific

Fundeni Clinical Institute
Department of Nephrology
Fundeni Street 258
Bucharest
022328
Romania

ORCiD logoORCID ID 0000-0003-4796-4950
Phone +40 721256797
Email bogdan.obrisca@drd.umfcd.ro

Study information

Study designProspective interventional open-label single-center non-randomised study
Primary study designInterventional
Secondary study designNon randomised study
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format. Please use contact details to request a participation information sheet
Scientific titleAn open-label study evaluating the efficacy and safety of budesonide in the treatment of patients with immunoglobulin A nephropathy
Study acronymBUDIGAN
Study objectivesGut-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(s)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
Health condition(s) or problem(s) studiedImmunoglobulin A nephropathy
InterventionPatients 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 typeDrug
Pharmaceutical study type(s)
PhasePhase IV
Drug / device / biological / vaccine name(s)Budesonide (Budenofalk®)
Primary outcome measureAt baseline and 36 months:
1. Estimated glomerular filtration rate
2. Extent of proteinuria and hematuria
3. MESTC score assessed by kidney biopsy
Secondary outcome measuresIncidence of budesonide-related adverse events over the 36 months
Overall study start date01/03/2020
Completion date31/12/2024

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants30 - 40
Total final enrolment32
Key inclusion criteria1. 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)
Key exclusion criteria1. 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
Date of first enrolment01/03/2020
Date of final enrolment31/12/2022

Locations

Countries of recruitment

  • Romania

Study participating centre

Fundeni Clinical Institute
Department of Nephrology
Fundeni Street number 258
Bucharest
022328
Romania

Sponsor information

Institutul Clinic Fundeni
Hospital/treatment centre

Fundeni Street 258
Bucharest
022328
Romania

Phone +40 213119190
Email secretariat@icfundeni.ro
Website http://icfundeni.ro/
ROR logo "ROR" https://ror.org/05w6fx554

Funders

Funder type

Other

Investigator initiated and funded

No information available

Results and Publications

Intention to publish date31/12/2025
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryData sharing statement to be made available at a later date
Publication and dissemination planPlanned to publish in a high-impact, peer-reviewed journal.
IPD sharing planAll data generated or analysed during this study will be included in the subsequent results publication.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article 17/11/2023 20/11/2023 Yes No

Editorial Notes

20/11/2023: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
14/02/2020: Trial’s existence confirmed by The Ethics Council of Fundeni Clinical Institute.