Diet Intervention in Food Sensitive Patients With IgA Nephropathy

Not Applicable

• Conditions: IGA Nephropathy

• Registration Number: NCT01203007
• Lead Sponsor: Uppsala University Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2010-09
• Study Start: 2010-09
• Study First Submitted: 2010-09-15
• Study First Submitted QC: 2010-09-15
• Study First Posted: 2010-09-16
• Last Update Submitted: 2010-09-16
• Last Update Posted: 2010-09-17
• Primary Completion: 2012-01
• Study Completion: 2012-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Proteinuria	6 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (3)

Haukeland University Hospital; 🇳🇴 Bergen, Norway

Linköping University Hospital; 🇸🇪 Linköping, Sweden

Uppsala University Hospital; 🇸🇪 Uppsala, Sweden