IGA Nephropathy
Conditions
Brief summary
The purpose of this study is to assess whether a tailored diet, eliminating antigens to which IgA nephropathy patients have demonstrated sensitivity, will have an effect on proteinuria, renal function and other immunological variables.
Interventions
DIETARY_SUPPLEMENTTailored diet
Tailored diet according to demonstrated food sensitivity, 6 months
DIETARY_SUPPLEMENTLow antigen content diet
Low-antigen content diet for one month
Sponsors
University Hospital, Linkoeping
Haukeland University Hospital
Smerud Medical Research International AS
Uppsala University Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Above 18 years * IgA nephropathy (IgAN), verified by biopsy * Proteinuria \> 1 g/24 h * Having signed informed consent form
Exclusion criteria
* Participation in another clinical trial * Patients with celiac disease * Introduction of an angiotensin-converting enzyme (ACE) inhibitor or angiotensin II receptor blockers (ARB) during the last three months prior to inclusion * Patients treated with immunosuppressive or systemic corticosteroid drugs within the last twelve months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proteinuria | 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Renal function | 6 months | Glomerular filtration rate (GFR) |
| IgA/IgG immune complexes, incl. glycosylation | 6 months | — |
| IgA/IgG to dietary antigens | 6 months | — |
| Hematuria | 6 months | — |
Countries
Norway, Sweden
Contacts
Primary ContactBengt Fellström, MD, PhD
Backup ContactHilde K Smerud, MScPharm
Outcome results
None listed