Mycophenolate Mofetil Versus Intravenous Cyclophosphamide Pulses in the Treatment of Crescentic IgA Nephropathy

Sponsor

Nanjing University School of Medicine (Other)

Overall Status

Completed

CT.gov ID

NCT00301600

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A single-center random parallel study to compare the efficacy and safety of Mycophenolate mofetil versus intravenous Cyclophosphamide pulses in the treatment of crescentic IgA nephropathy

Condition or Disease	Intervention/Treatment	Phase
IGA Nephropathy	Drug: Mycophenolate mofetil	N/A

Detailed Description

IgA nephropathy is an immune-complex glomerulopathy that can result in capillary necrosis or extracapillary proliferation (crescents). Several studies have documented a higher incidence of hypertension and nephritic-range proteinuria in patients with the crescentic form of IgA nephropathy, suggesting that patients with this variant of the disease may have a worse prognosis. Some studies have shown that treatment with steroids and cyclophosphamide had efficacy on reducing proteinuria and preserving renal function by healing vasculitic lesions, therefore preventing the progression of glomerular sclerosis. Recent studies have also shown that mycophenolate mofetil is effective in the treatment of lupus nephritis with vasculitic lesion and small vasculitis with renal involvement. We will conduct a single-center prospective open-labeled clinical trial of 40 patients with crescentic IgA nephropathy and treat them randomly with pulse intravenous cyclophosphamide or oral mycophenolate mofetil. After 12 months of treatment, we will assess the efficacy, safety, tolerability and relapse of mycophenolate mofetil compared with cyclophosphamide in the treatment of crescentic IgA nephropathy.

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Mycophenolate Mofetil Versus Intravenous Cyclophosphamide Pulses in the Treatment of Crescentic IgA Nephropathy

Study Start Date :

Jan 1, 2003

Actual Primary Completion Date :

May 1, 2005

Actual Study Completion Date :

Jan 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Mycophenolate mofeti	Drug: Mycophenolate mofetil MMF,1.0g/d Other Names: MMF,cellcept

Arm

Intervention/Treatment

Active Comparator: Mycophenolate mofeti

Drug: Mycophenolate mofetil

MMF,1.0g/d

Other Names:

MMF,cellcept

Outcome Measures

Primary Outcome Measures

To compare the efficacy and safety of Mycophenolate mofetil versus intravenous Cyclophosphamide pulses in the treatment of crescentic IgA nephropathy [12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patient with a diagnosis of IgAN without deposition of C4 and C1q, age 10-70y, sex free

Gross hematuria or an active urine sediment
Segmental necrotizing lesion of the capillary wall
Cellular or fibrocellular crescents ≥ 10%
Fibrinoid degeneration of small vessels
Fibrin positive Three or more items, with provision of criteria informed consent

Exclusion Criteria:

More than four-week treatment with cytotoxic drug, such as CTX, CsA and MMF, prior to enrollment
Immune deficiency
Serum creatinine ≥ 5.0mg/dl
Previous malignancy
Pregnancy
Hepatitis
Diabetic mellitus or obesity
Severe infection or CVS complications
Henoch-Schonlein purpura nephritis, systemic vasculitis, SLE