Clinical trial NCT00301600: Mycophenolate Mofetil Versus Intravenous Cyclophosphamide Pulses in the Treatment of Crescentic IgA Nephropathy
Official title: Mycophenolate Mofetil Versus Intravenous Cyclophosphamide Pulses in the Treatment of Crescentic IgA Nephropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: IGA Nephropathy
Keywords: Crescentic IgA nephropathy
Mycophenolate mofetil
Cyclophosphamide
treatment
Lead sponsor: Nanjing University School of Medicine
Sponsor class: OTHER
First posted: 2006-03-13
Enrollment: 40
Sex: ALL
Minimum age (years): 12
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: 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.

Eligibility criteria: 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

Primary outcomes:
measure: To compare the efficacy and safety of Mycophenolate mofetil versus intravenous Cyclophosphamide pulses in the treatment of crescentic IgA nephropathy
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine
state: Jiangsu
Study officials:
affiliation: Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine
name: Lei-Shi Li, M.D.
role: STUDY_CHAIR
References: