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Diet Intervention in Food Sensitive Patients With IgA Nephropathy (DIIGA)

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ClinicalTrials.gov Identifier: NCT01203007
Recruitment Status : Unknown
Verified September 2010 by Uppsala University Hospital.
Recruitment status was:  Not yet recruiting
First Posted : September 16, 2010
Last Update Posted : September 17, 2010
Sponsor:
Collaborators:
University Hospital, Linkoeping
Haukeland University Hospital
Smerud Medical Research International AS
Information provided by:
Uppsala University Hospital

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
IGA Nephropathy Dietary Supplement: Tailored diet Dietary Supplement: Low antigen content diet Not Applicable

Study Design
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study of 6 Months Diet Intervention in Food Sensitive Patients With IgA Nephropathy
Study Start Date : September 2010
Estimated Primary Completion Date : January 2012
Estimated Study Completion Date : March 2012

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U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Tailored diet
Tailored diet according to demonstrated food sensitivity
 Dietary Supplement: Tailored diet
Tailored diet according to demonstrated food sensitivity, 6 months
Experimental: Low-antigen content (LAC) diet
Low-antigen content diet
 Dietary Supplement: Low antigen content diet
Low-antigen content diet for one month


Outcome Measures
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Proteinuria [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Renal function [ Time Frame: 6 months ]
    Glomerular filtration rate (GFR)

  2. IgA/IgG immune complexes, incl. glycosylation [ Time Frame: 6 months ]
  3. IgA/IgG to dietary antigens [ Time Frame: 6 months ]
  4. Hematuria [ Time Frame: 6 months ]

Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01203007


Contacts
Contact: Bengt Fellström, MD, PhD +46 18 611 4348 bengt.fellstrom@medsci.uu.se
Contact: Hilde K Smerud, MScPharm +47 9011 6812 hilde.smerud@medsci.uu.se

Locations
Norway
Haukeland University Hospital Not yet recruiting
Bergen, Norway
Principal Investigator: Rune Bjørneklett, MD         
Sweden
Linköping University Hospital Not yet recruiting
Linköping, Sweden
Principal Investigator: Anders Fernström, MD, PhD         
Uppsala University Hospital Not yet recruiting
Uppsala, Sweden
Contact: Bengt Fellström, MD, PhD    +46 18 611 4348    bengt.fellstrom@medsci.uu.se   
Contact: Hilde K Smerud, MScPharm    +479011 6812    hilde.smerud@medsci.uu.se   
Principal Investigator: Bengt Fellström, MD, PhD         
Sponsors and Collaborators
Uppsala University Hospital
University Hospital, Linkoeping
Haukeland University Hospital
Smerud Medical Research International AS
Investigators
Study Director: Hilde K Smerud, MScPharm Uppsala University Hospital
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Bengt Fellström, Uppsala University Hospital
ClinicalTrials.gov Identifier: NCT01203007     History of Changes
Other Study ID Numbers: SMR-2259
First Posted: September 16, 2010    Key Record Dates
Last Update Posted: September 17, 2010
Last Verified: September 2010

Additional relevant MeSH terms:
Kidney Diseases
Glomerulonephritis, IGA
Urologic Diseases
Glomerulonephritis
 Nephritis
Autoimmune Diseases
Immune System Diseases