IgA Nephropathy
Conditions
Brief summary
The study is to evaluate the effect of Mycophenolate Mofetil compared with losartan alone on time to doubling of serum creatinine or the onset of end stage renal disease in patients with advanced IgA nephropathy who are treated with the maximal tolerated daily dose of losartan.The study will also assess the effects of MMF compared with losartan alone on the changes of urine albumin excretion and the changes in estimated glomerular filtration rate.
Interventions
DRUGMycophenolate mofetil
Mycophenolate mofetil 1.5g/day plus maximum tolerated labeled dose losartan
DRUGLosartan
Maximum tolerated labeled dose of Losartan
Sponsors
Fan Fan Hou
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Biopsy-proven primary IgA nephropathy with urinary proteinuria excretion over 1g/24 hour,subjects must meet 2 of the following criteria: 1. global glomerular sclerosis plus focal segmental glomerular sclerosis ratio ≥50% 2. eGFR 30 to 60 ml/min 3. Hypertension (blood pressure over 140/90 mmHg or taking antihypertensive drugs)
Exclusion criteria
1. Secondary IgA nephropathy 2. Familial IgA nephropathy 3. Concomitant disease: cancer, infection, diabetes mellitus, connective tissue disease, abnormal liver function 4. Pregnancy or breasting 5. Inability to comply with study and follow-up procedures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the effects of mycophenolate mofetil on a composite renal outcomes in subjects with advanced IgA nephropathy | 3 years | Time to the first occurrence of a component of the composite renal endpoint: Doubling of serum creatinine or the onset of end stage renal disease (ESRD) \[needing chronic dialysis or renal transplantation or renal death\] |
| To evaluate the effects of mycophenolate mofetil on progression of CKD in subjects with advanced IgA nephropathy | 3 years | A decrease in eGFR of 30% or more and to a level of less than 60 ml/min at the exit visit if the baseline eGFR was 60 ml/min or more. Or a decrease in eGFR of 50% or more at the exit visit if the baseline eGFR was less than 60 ml/min. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the effects of mycophenolate mofetil on the changes of proteinuria in subjects with advanced IgA nephropathy | 3 years | Changes of urinary protein excretion rate |
| To evaluate the effects of mycophenolate mofetil rapid progression of CKD in subjects with advanced IgA nephropathy | 3 years | Time to 30% reduction in estimated glomerular filtration rate (eGFR); eGFR reduction greater than 5 ml/min/1.73m\^2/year |
Countries
China
Outcome results
None listed