Diet Intervention in Food Sensitive Patients With IgA Nephropathy

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01203007
• Date of registration: 15/09/2010
• Prospective Registration: No
• Primary sponsor: Uppsala University Hospital
• Public title: Diet Intervention in Food Sensitive Patients With IgA Nephropathy DIIGA
• Scientific title: A Pilot Study of 6 Months Diet Intervention in Food Sensitive Patients With IgA Nephropathy
• Date of first enrolment: September 2010
• Target sample size: 40
• Recruitment status: Not yet recruiting
• URL: http://clinicaltrials.gov/show/NCT01203007
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: N/A

Countries of recruitment

Norway, Sweden

Contacts

• Name: Bengt Fellström, MD, PhD

• Name: Bengt Fellström, MD, PhD

• Name: Hilde K Smerud, MScPharm
• Affiliation: Uppsala University Hospital

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

IGA Nephropathy

Intervention(s)

Dietary Supplement: Tailored diet

Dietary Supplement: Low antigen content diet

Primary Outcome(s)

Proteinuria [Time Frame: 6 months]

Secondary Outcome(s)

Renal function [Time Frame: 6 months]

IgA/IgG to dietary antigens [Time Frame: 6 months]

Hematuria [Time Frame: 6 months]

IgA/IgG immune complexes, incl. glycosylation [Time Frame: 6 months]

Secondary ID(s)

SMR-2259

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Smerud Medical Research International AS

University Hospital, Linkoeping

Haukeland University Hospital