Evaluation of the efficacy and safety of prolonged-release budesonide in children with primary IgA nephropathy.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Medical University Of Warsaw

Participant type

Pediatric, Patients

Age range

0-17 years

Gender

Male and Female

Therapeutic area

Not possible to specify

Decision date (initial)

2025-06-27

Transition trial

No

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

Yes

Funding sources

Medical Research Agency

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

1. Proving that Budesonide DR in combination with ACEI is more effective than placebo in reducing proteinuria.
2. To assess whether treatment with Budesonide DR is better than treatment with Prednisone in reducing proteinuria in the study population.

Secondary objectives 2

1. Assessment of the safety profile of Budesonide DR in the pediatric population with IgAN compared to SoC and Prednisone
2. Confirmation of the effectiveness of the used dose of Budesonide DR in the pediatric population with IgAN

Conditions and MedDRA coding

Children primary nephropathy IgA

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. obtaining consent from the parent/legal guardian and the patient to participate in the study
2. age 8-17 years
3. primary IgA nephropathy diagnosed on kidney biopsy
4. no treatment or treatment with ACEI/ARB
5. steroid treatment or immunosuppressive treatment completed at least 2 months previously
6. proteinuria >200 mg/day or protein-creatinine ratio (UPR) >0.2 g/g in three tests
7. negative pregnancy test result (urine platelet) at the time of qualification to start treatment

Exclusion criteria 10

1. secondary forms of IgA nephropathy, e.g. nephropathy associated with IgA vasculitis (IgAVN), IgA nephropathy in the course of Crohn's disease
2. rapidly progressive glomerulonephritis in the course of IgAN
3. GFR < 60 ml/min according to Schwartz at the time of randomization
4. currently or less than 2 months before the screenig used systemic steroid therapy or immunosuppressive treatment such as: azathioprine, mycophenolate mofetil, cyclophosphamide, tacrolimus, cyclosporine A
5. chronic diseases that, in the opinion of the researcher, may affect the course of treatment, e.g. tuberculosis
6. severe heart disease
7. active peptic ulcer disease of the stomach and/or duodenum
8. history of prednisone intolerance
9. cataract, glaucoma
10. pregnancy or breastfeeding

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Reduction of UPCR after 24 weeks of treatment
2. Assessment of the percentage change in proteinuria at the end of treatment compared to the beginning of treatment

Secondary endpoints 3

1. Number of side effects.
2. Reduction in GFR during treatment
3. Reduction of UPCR after 24 weeks of treatment in relation to the beginning of treatment (deltaUPCR)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 2

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Medical University Of Warsaw

Sponsor organisation

Medical University Of Warsaw

Address

Ul. Zwirki I Wigury 61

City

Warsaw

Postcode

02-091

Country

Poland

Scientific contact point

Organisation

Medical University Of Warsaw

Contact name

Małgorzata Mizerska-Wasiak

Public contact point

Organisation

Medical University Of Warsaw

Contact name

Małgorzata Mizerska-Wasiak

Locations

1 EU/EEA country · 8 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 46 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

4 submissions — initial application plus substantial / non-substantial modifications