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

Nanjing University School of Medicine

Status: Completed

Conditions: IGA Nephropathy

Treatments: Drug: Mycophenolate mofetil

Study type: Interventional

Funder types: Other

Identifiers

NCT00301600

NJCT-0606

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 12 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Mycophenolate mofeti

Active Comparator group

Treatment:

Drug: Mycophenolate mofetil