Diet Intervention in Food Sensitive Patients With IgA Nep... | NCT01203007

Studies
Diet Intervention in Food Sensitive Patients With IgA Nephropathy

NCT01203007

Sponsor

Uppsala University Hospital

Status

Unknown status

Last Update Posted

Sep 17, 2010Estimated

Enrollment

40Estimated

Phase

Not Applicable

Conditions

IGA Nephropathy

Interventions

Tailored diet
Low antigen content diet

Countries

Norway
Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2010

Primary Completion Date

Jan 2012Estimated

Completion Date

Mar 2012Estimated

First Submitted Date

Sep 15, 2010

First Submission Date that Met QC Criteria

Sep 15, 2010

First Posted Date

Sep 16, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 16, 2010

Last Update Posted Date

Sep 17, 2010Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Uppsala University HospitalOTHER

Collaborators

Name	Class
University Hospital, Linkoeping	OTHER
Haukeland University Hospital	OTHER
Smerud Medical Research International AS	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Tailored diet	Dietary Supplement	Tailored diet according to demonstrated food sensitivity, 6 months	Tailored diet

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Proteinuria		6 months

Secondary Outcomes

Measure	Description	Time Frame
Renal function	Glomerular filtration rate (GFR)	6 months
IgA/IgG immune complexes, incl. glycosylation		6 months

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Bengt Fellström, MD, PhD	Contact	+46 18 611 4348		bengt.fellstrom@medsci.uu.se
Hilde K Smerud, MScPharm	Contact	+47 9011 6812		hilde.smerud@medsci.uu.se

Overall Officials

Name	Affiliation	Role
Hilde K Smerud, MScPharm	Uppsala University Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Haukeland University Hospital		Bergen			Norway

Condition Browse Module

MeSH Terms

ID	Term
D005922	Glomerulonephritis, IGA

Ancestor Terms

ID	Term
D005921	Glomerulonephritis
D009393	Nephritis
D007674	Kidney Diseases
D014570	Urologic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided