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

Completed

• Conditions: IgA Nephropathy; Urological and Genital Diseases

• Registration Number: ISRCTN62574616
• Lead Sponsor: Medical City Dallas Hospital (USA)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2004-03-11
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.