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 measure
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 (if study stopped)
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, OMACOR® 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
Basic results (scientific)
Publication list
Protocol in http://www.ncbi.nlm.nih.gov/pubmed/15043759
Publication citations
-
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.