Condition category
Urological and Genital Diseases
Date applied
12/02/2020
Date assigned
14/02/2020
Last edited
14/02/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

http://icfundeni.ro/

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

Publication citations

Additional files

Editorial Notes

14/02/2020: Trial’s existence confirmed by The Ethics Council of Fundeni Clinical Institute.