Clinical trial NCT01854814: The Effects of Mycophenolate Mofetil (MMF) on Renal Outcomes in Advanced Immunoglobulin A (IgA) Nephropathy Patients
Official title: The Effects of Mycophenolate Mofetil on Renal Outcomes in Patients With Advanced IgA Nephropathy: a Randomized Open-label Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: IgA Nephropathy
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2013-05-16
Enrollment: 238
Sex: ALL
Minimum age (years): 16
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: To evaluate the effects of mycophenolate mofetil on a composite renal outcomes in subjects with advanced IgA nephropathy
timeFrame: 3 years
measure: To evaluate the effects of mycophenolate mofetil on progression of CKD in subjects with advanced IgA nephropathy
timeFrame: 3 years
Secondary outcomes:
measure: To evaluate the effects of mycophenolate mofetil on the changes of proteinuria in subjects with advanced IgA nephropathy
timeFrame: 3 years
measure: To evaluate the effects of mycophenolate mofetil rapid progression of CKD in subjects with advanced IgA nephropathy
timeFrame: 3 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Nanfang Hospital Southern Medical University
state: Guangdong
city: Shenzhen
country: China
facility: The Fourth People's Hospital Shenzhen
state: Guangdong
city: Zhanjiang
country: China
facility: The Institute of Nephrology, Guangdong Medical College
state: Guangdong
Study officials:
affiliation: Division of nephrology, Nanfang Hospital Southern Medical University
name: Fan Fan Hou, M.D., PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tang SC, Tang AW, Wong SS, Leung JC, Ho YW, Lai KN. Long-term study of mycophenolate mofetil treatment in IgA nephropathy. Kidney Int. 2010 Mar;77(6):543-9. doi: 10.1038/ki.2009.499. Epub 2009 Dec 23.
citation: Frisch G, Lin J, Rosenstock J, Markowitz G, D'Agati V, Radhakrishnan J, Preddie D, Crew J, Valeri A, Appel G. Mycophenolate mofetil (MMF) vs placebo in patients with moderately advanced IgA nephropathy: a double-blind randomized controlled trial. Nephrol Dial Transplant. 2005 Oct;20(10):2139-45. doi: 10.1093/ndt/gfh974. Epub 2005 Jul 19.