IGA NephropathyDIIGANCT01203007
Diet Intervention in Food Sensitive Patients With IgA Nephropathy
A study testing Tailored diet and Low antigen content diet in people with IGA Nephropathy, run by Uppsala University Hospital at 3 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- IGA Nephropathy
- What is being tested?
- Tailored diet and Low antigen content diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Sep 2010to Mar 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Above 18 years
- IgA nephropathy (IgAN), verified by biopsy
- Proteinuria > 1 g/24 h
- Having signed informed consent form
Who cannot join
- 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
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Sweden2 sites
Linköping University Hospital
Linköping
Anders Fernström, MD, PhD
Uppsala University Hospital
Uppsala
Bengt Fellström, MD, PhD, +46 18 611 4348, bengt.fellstrom@medsci.uu.se
Hilde K Smerud, MScPharm, +479011 6812, hilde.smerud@medsci.uu.se
About this study
Official title: A Pilot Study of 6 Months Diet Intervention in Food Sensitive Patients With IgA Nephropathy
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.
- Conditions
- IGA Nephropathy
- Being tested
- Tailored diet, Low antigen content diet
- Medical subject headings
- Glomerulonephritis, IGA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tailored dietDietary supplement
Tailored diet according to demonstrated food sensitivity, 6 months
Low antigen content dietDietary supplement
Low-antigen content diet for one month
| Study group | Role | What they receive |
|---|---|---|
| Tailored diet | Experimental | Tailored diet according to demonstrated food sensitivity Receives: Dietary Supplement: Tailored diet |
| Low-antigen content (LAC) diet | Experimental | Low-antigen content diet Receives: Dietary Supplement: Low antigen content diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proteinuria
Measured: 6 months
Secondary outcomes (4)
Renal function
Glomerular filtration rate (GFR)
Measured: 6 months
IgA/IgG immune complexes, incl. glycosylation
Measured: 6 months
IgA/IgG to dietary antigens
Measured: 6 months
Hematuria
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionJan 2012 (estimated)
- Study completionMar 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IGA NephropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uppsala University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Linkoeping, Haukeland University Hospital, Smerud Medical Research International AS
- Investigators
- Hilde K Smerud, MScPharm, Study director, Uppsala University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01203007
- Sponsor's protocol ID
- SMR-2259
- Acronym
- DIIGA
- Status last verified
- Sep 2010
- First submitted
- 15 Sep 2010
- Last updated
- 17 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of 6 Months Diet Intervention in Food Sensitive Patients With IgA Nephropathy
- ClinicalTrials.gov ID
- NCT01203007
- Acronym / sponsor ID
- DIIGA / SMR-2259
- Conditions
- IGA Nephropathy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Uppsala University HospitalUniversity, hospital or other
- Collaborators
- University Hospital, Linkoeping, Haukeland University Hospital, Smerud Medical Research International AS
- Study start
- Sep 2010
- Primary completion
- Jan 2012 (estimated)
- Study completion
- Mar 2012 (estimated)
- First posted
- 16 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tailored diet | Experimental | Dietary Supplement: Tailored dietTailored diet according to demonstrated food sensitivity |
| Low-antigen content (LAC) diet | Experimental | Dietary Supplement: Low antigen content dietLow-antigen content diet |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Above 18 years
- IgA nephropathy (IgAN), verified by biopsy
- Proteinuria > 1 g/24 h
- Having signed informed consent form
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tailored dietTailored diet according to demonstrated food sensitivity, 6 months | Dietary supplement | Tailored diet |
| Low antigen content dietLow-antigen content diet for one month | Dietary supplement | Low-antigen content (LAC) diet |
Primary outcome
Proteinuria
Time frame: 6 months
4 secondary outcomes
Renal function
Time frame: 6 months
IgA/IgG immune complexes, incl. glycosylation
Time frame: 6 months
IgA/IgG to dietary antigens
Time frame: 6 months
Hematuria
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2010.
Related trials for IGA Nephropathy
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Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
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A Study of Mezagitamab in Adults With Kidney Condition Called IgA Nephropathy
Kidney Disease
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MYTP01 for Immune-Mediated Diseases
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RecruitingPhase 2
Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of KP104 to Treat Glomerulonephritis
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RecruitingPhase 3
A Phase 3 Blinded Study of JADE101 in Participants With Immunoglobulin A Nephropathy
IgA Nephropathy (IgAN)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hilde K Smerud, MScPharm study director
Uppsala University Hospital
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tailored diet and Low antigen content diet in people with IGA Nephropathy, run by Uppsala University Hospital at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Sweden, Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bengt Fellström, MD, PhD (+46 18 611 4348, bengt.fellstrom@medsci.uu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proteinuria (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2010.