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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

238 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2022-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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IgA Nephropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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mycophenolate mofetil

mycophenolate mofetil 1.5g/day and maximum tolerated labeled dose of losartan

Group Type EXPERIMENTAL

Mycophenolate mofetil

Intervention Type DRUG

Mycophenolate mofetil 1.5g/day plus maximum tolerated labeled dose losartan

losartan

maximus tolerated labeled dose of losartan

Group Type ACTIVE_COMPARATOR

Losartan

Intervention Type DRUG

Maximum tolerated labeled dose of Losartan

Interventions

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Mycophenolate mofetil

Mycophenolate mofetil 1.5g/day plus maximum tolerated labeled dose losartan

Intervention Type DRUG

Losartan

Maximum tolerated labeled dose of Losartan

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

16 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No