A Randomised Controlled Trial of Mycophenolate Mofetil (MMF) in Patients with Immunoglobulin A (IgA) Nephropathy (IgAN)

ISRCTN	ISRCTN62574616
DOI	https://doi.org/10.1186/ISRCTN62574616
Secondary identifying numbers	N/A

Submission date: 09/03/2004
Registration date: 11/03/2004
Last edited: 08/08/2008

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Urological and Genital Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Ronald Hogg
Scientific

7777 Forest Lane
Suite C740
Dallas, Texas
75230
United States of America

Phone	+1 972 566 5575
Email	spnsg@lonestarhealth.com

Study information

Study design	Multicentre, double-blind placebo-controlled, randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	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 study start date	01/01/2003
Completion date	01/01/2005

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Both
Target number of participants	100
Key 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
Key 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
Date of first enrolment	01/01/2003
Date of final enrolment	01/01/2005

Locations

Countries of recruitment

Canada
United States of America

Study participating centre

7777 Forest Lane

Dallas, Texas
75230
United States of America

Sponsor information

Medical City Dallas Hospital (USA)
Hospital/treatment centre

7777 Forest Lane
Suite C740
Dallas, Texas
75230
United States of America

Phone	+1 972 566 5575
Email	spnsg@lonestarhealth.com
"ROR"	https://ror.org/059rc1n32

Funders

Funder type

Hospital/treatment centre

Medical City Dallas Hospital (USA)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	Protocol	25/03/2004		Yes	No