The Effects of Mycophenolate Mofetil (MMF) on Renal Outcomes in Advanced Immunoglobulin A (IgA) Nephropathy Patients

IgA Nephropathy Clinical Trial

— MAIN  

Official title:

The Effects of Mycophenolate Mofetil on Renal Outcomes in Patients With Advanced IgA Nephropathy: a Randomized Open-label Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01854814
• Other study ID #: MAIN
• Status: Completed
• Phase: N/A
• Start date: July 2013
• Est. completion date: May 2022

Study information

• Verified date: July 2022
• Source: Nanfang Hospital of Southern Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 238
• Est. completion date: May 2022
• Est. primary completion date: February 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Glomerulonephritis, IGA
• IgA Nephropathy
• Kidney Diseases

Intervention

Drug:
• Mycophenolate mofetil
Mycophenolate mofetil 1.5g/day plus maximum tolerated labeled dose losartan
• Losartan
Maximum tolerated labeled dose of Losartan

Locations

Country	Name	City	State
China	Nanfang Hospital Southern Medical University	Guangzhou	Guangdong
China	The Fourth People's Hospital Shenzhen	Shenzhen	Guangdong
China	The Institute of Nephrology, Guangdong Medical College	Zhanjiang	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Fan Fan Hou

Country where clinical trial is conducted

China, 

References & Publications (2)

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. Epub 2005 Jul 19. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the effects of mycophenolate mofetil on a composite renal outcomes in subjects with advanced IgA nephropathy	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]	3 years
Primary	To evaluate the effects of mycophenolate mofetil on progression of CKD in subjects with advanced IgA nephropathy	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.	3 years
Secondary	To evaluate the effects of mycophenolate mofetil on the changes of proteinuria in subjects with advanced IgA nephropathy	Changes of urinary protein excretion rate	3 years
Secondary	To evaluate the effects of mycophenolate mofetil rapid progression of CKD in subjects with advanced IgA nephropathy	Time to 30% reduction in estimated glomerular filtration rate (eGFR); eGFR reduction greater than 5 ml/min/1.73m^2/year	3 years