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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00301600

Enrollment

Registered

2006-03-13

Start date

2003-01-31

Completion date

2006-01-31

Last updated

2010-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

IGA Nephropathy

Keywords

Crescentic IgA nephropathy, Mycophenolate mofetil, Cyclophosphamide, treatment

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

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.

Interventions

DRUGMycophenolate mofetil

MMF,1.0g/d

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

12 Years to 65 Years

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

Design outcomes

Primary

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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026