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ClinicalTrials.gov ID

NCT01203007

Lead Sponsor

Uppsala University HospitalOTHER

Overall Status

Unknown status

Study Type

Interventional

Phase

Not Applicable

Enrollment

40Estimated

Last Update Posted

Sep 17, 2010Estimated

Start Date

Sep 2010

Primary Completion Date

Jan 2012Estimated

Completion Date

Mar 2012Estimated

Official Title

A Pilot Study of 6 Months Diet Intervention in Food Sensitive Patients With IgA Nephropathy

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.

• IGA Nephropathy

• Tailored diet
• Low antigen content diet

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility 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

Primary Purpose

Treatment

Allocation

Non-Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

Uppsala University HospitalOTHER

Collaborators

University Hospital, LinkoepingOTHER

Haukeland University HospitalOTHER

Smerud Medical Research International ASOTHER

bengt.fellstrom@medsci.uu.se+46 18 611 4348