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 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | 1975 |
| Sponsor | Institutul Clinic Fundeni |
| Funder | Investigator initiated and funded |
- 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
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
Scientific
Fundeni Clinical Institute
Department of Nephrology
Fundeni Street 258
Bucharest
022328
Romania
 ORCID ID |
0000-0003-3306-189X |
|---|---|
| Phone | +40 722792429 |
| gener732000@yahoo.com |
Scientific
Fundeni Clinical Institute
Department of Nephrology
Fundeni Street 258
Bucharest
022328
Romania
| ORCID ID |
0000-0003-4796-4950 |
|---|---|
| Phone | +40 721256797 |
| bogdan.obrisca@drd.umfcd.ro |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Prospective interventional open-label single-center non-randomised study |
| Secondary study design | Non randomised study |
| Study type | Participant information sheet |
| Scientific title | An open-label study evaluating the efficacy and safety of budesonide in the treatment of patients with immunoglobulin A nephropathy |
| Study acronym | BUDIGAN |
| Study objectives | 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(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) studied | 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 / device / biological / vaccine name(s) | Budesonide (Budenofalk®) |
| Primary outcome measure(s) |
At baseline and 36 months: |
| Key secondary outcome measure(s) |
Incidence of budesonide-related adverse events over the 36 months |
| Completion date | 31/12/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 40 |
| Total final enrolment | 32 |
| Key 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) |
| Key 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 |
| Date of first enrolment | 01/03/2020 |
| Date of final enrolment | 31/12/2022 |
Locations
Countries of recruitment
- Romania
Study participating centre
Fundeni Street number 258
Bucharest
022328
Romania
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| IPD sharing plan | All 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
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.
