Condition category
Urological and Genital Diseases
Date applied
09/03/2004
Date assigned
11/03/2004
Last edited
08/08/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Ronald Hogg

ORCID ID

Contact details

7777 Forest Lane
Suite C740
Dallas
Texas
75230
United States of America
+1 972 566 5575
spnsg@lonestarhealth.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

To undertake a multicentre, randomised controlled trial designed to test the hypothesis that treatment with MMF will lead to significant and sustained improvement in proteinuria in patients with IgAN who have been pre-treated (and continue to be treated) with ACEi and FOS compared to a placebo control group of patients receiving comparable doses of ACEi and FOS without MMF.

Ethics approval

Not provided at time of registration

Study design

Multicentre, double-blind placebo-controlled, randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

IgA Nephropathy

Intervention

All subjects receive lisonopril and fish oil supplements. After three months, subjects are randomised to either MMF or the placebo for one year.

Intervention type

Drug

Phase

Not Specified

Drug names

Mycophenolate Mofetil

Primary outcome measures

Change from entry level in urine P/C ratio. Data for this outcome will be examined every 6 months until the end of the study two years after randomisation.

Secondary outcome measures

Change in estimated Glomerular Filtration Rate (estGFR). We realise that the likelihood of detecting significant changes in GFR in this short-term study is remote.

Overall trial start date

01/01/2003

Overall trial end date

01/01/2005

Reason abandoned

Eligibility

Participant inclusion criteria

25 centres in United States and Canada:
1. Aged seven to 70
2. Renal biopsy diagnostic for IgAN based on immunohistologic staining for IgA that is greater than or equal to staining for IgG and IgM after the biopsy report has been evaluated by one of the study pathologists (entry into the study does not depend upon any specific time interval between the time of the renal biopsy and the time of entry)
3. Ability to swallow the oral medications used in the study
4. Signed informed consent by subjects aged over 18, and parent/guardian of any subject aged under 18, with a subject aged seven to 18 also signing an age-appropriate assent form
5. Urine Protein/Creatinine ratio more than or equal to 0.8 for males and more than or equal to 0.6 for females prior to randomisation
6. For female subjects of childbearing potential, a negative pregnancy test one week prior to starting lisinopril, and again less than one week before starting MMF or placebo

Participant type

Patient

Age group

Not Specified

Gender

Both

Target number of participants

100

Participant exclusion criteria

1. Clinical and histologic evidence of systemic lupus erythematosus
2. Well-documented history of Henoch-Schonlein purpura (previous non-specific abdominal pain or rash does not exclude a subject)
3. Cirrhosis, chronic active liver disease, hepatitis B, hepatitis C
4. History of significant gastrointestinal disorder (e.g. severe chronic diarrhea or active peptic ulcer disease)
5. Human Immunodeficiency Virus (HIV)
6. Any systemic infection or history of serious infection within one month of entry
7. Absolute Neutrophil Count (ANC) less than 2000/mm^3
8. Hematocrit (HCT) less than 28% (anemic subjects may be reevaluated after the anemia has been treated)
9. Estimated glomerular filtration rate (estGFR) less than 40 ml/min/1.73m^2 at time of randomisation (it is acceptable for the estGFR to fall to less than 40 ml/min/1.73m^2 during treatment with MMF or placebo provided the level prior to randomisation is still more than or equal to 60% of the pre-entry value)
10. Known contraindication to the administration of MMF, OMACORĀ® or lisinopril (or losartan if used instead of lisinopril)
11. Other major organ system disease or malignancy except skin cancer fully excised more than five years prior to entry
12. Current or prior treatment with MMF or azathioprine
13. Pregnancy or breast feeding at time of entry or unwillingness to comply with measures for contraception
14. Current or recent (within 30 days) exposure to any investigational drug

Recruitment start date

01/01/2003

Recruitment end date

01/01/2005

Locations

Countries of recruitment

Canada, United States of America

Trial participating centre

7777 Forest Lane
Dallas, Texas
75230
United States of America

Sponsor information

Organisation

Medical City Dallas Hospital (USA)

Sponsor details

7777 Forest Lane
Suite C740
Dallas
Texas
75230
United States of America
+1 972 566 5575
spnsg@lonestarhealth.com

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Medical City Dallas Hospital (USA)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Protocol in http://www.ncbi.nlm.nih.gov/pubmed/15043759

Publication citations

  1. Protocol

    Hogg RJ, Wyatt RJ, , A randomized controlled trial of mycophenolate mofetil in patients with IgA nephropathy [ISRCTN62574616]., BMC Nephrol, 2004, 5, 3, doi: 10.1186/1471-2369-5-3.

Additional files

Editorial Notes