NCT01203007

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.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2010

Geographic Reach
2 countries

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

September 15, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 16, 2010

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

September 17, 2010

Status Verified

September 1, 2010

Enrollment Period

1.3 years

First QC Date

September 15, 2010

Last Update Submit

September 16, 2010

Conditions

IGA Nephropathy

Outcome Measures

Primary Outcomes (1)

  • Proteinuria

    6 months

Secondary Outcomes (4)

  • Renal function

    6 months

  • IgA/IgG immune complexes, incl. glycosylation

    6 months

  • IgA/IgG to dietary antigens

    6 months

  • Hematuria

    6 months

Study Arms (2)

Tailored diet

EXPERIMENTAL

Tailored diet according to demonstrated food sensitivity

Dietary Supplement: Tailored diet

Low-antigen content (LAC) diet

EXPERIMENTAL

Low-antigen content diet

Dietary Supplement: Low antigen content diet

Interventions

Tailored dietDIETARY_SUPPLEMENT

Tailored diet according to demonstrated food sensitivity, 6 months

Tailored diet
Low antigen content dietDIETARY_SUPPLEMENT

Low-antigen content diet for one month

Low-antigen content (LAC) diet

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Above 18 years
  • IgA nephropathy (IgAN), verified by biopsy
  • Proteinuria \> 1 g/24 h
  • Having signed informed consent form

You may not qualify if:

  • Participation in another clinical trial
  • Patients with celiac disease
  • Patients treated with immunosuppressive or systemic corticosteroid drugs within the last twelve months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Haukeland University Hospital

Bergen, Norway

Location

Linköping University Hospital

Linköping, Sweden

Location

Uppsala University Hospital

Uppsala, Sweden

Location

MeSH Terms

Conditions

Glomerulonephritis, IGA

Condition Hierarchy (Ancestors)

GlomerulonephritisNephritisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Hilde K Smerud, MScPharm

    Uppsala University Hospital

    STUDY DIRECTOR

Central Study Contacts

Bengt Fellström, MD, PhD

CONTACT

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

Hilde K Smerud, MScPharm

CONTACT

+47 9011 6812hilde.smerud@medsci.uu.se

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 15, 2010

First Posted

September 16, 2010

Study Start

September 1, 2010

Primary Completion

January 1, 2012

Study Completion

March 1, 2012

Last Updated

September 17, 2010

Record last verified: 2010-09

Locations

SE(2)NO(1)