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

Not Applicable

Completed

• Conditions: IgA Nephropathy
• Interventions: Drug: Losartan; Drug: Mycophenolate mofetil

• Registration Number: NCT01854814
• Lead Sponsor: Fan Fan Hou

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-05-09
• Study First Submitted QC: 2013-05-15
• Study First Posted: 2013-05-16
• Study Start: 2013-07
• Primary Completion: 2022-02
• Study Completion: 2022-05
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-07
• Last Update Posted: 2022-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 238

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
losartan	Losartan	maximus tolerated labeled dose of losartan
mycophenolate mofetil	Mycophenolate mofetil	mycophenolate mofetil 1.5g/day and maximum tolerated labeled dose of losartan

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (3)

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, China