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

IGA Nephropathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00301600
• Other study ID #: NJCT-0606
• Status: Completed
• Phase: N/A
• First received: March 10, 2006
• Last updated: May 25, 2010
• Start date: January 2003
• Est. completion date: January 2006

Study information

• Verified date: July 2008
• Source: Nanjing University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 2006
• Est. primary completion date: May 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glomerulonephritis, IGA
• IGA Nephropathy
• Kidney Diseases

Intervention

Drug:
• Mycophenolate mofetil
MMF,1.0g/d

Locations

Country	Name	City	State
China	Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To compare the efficacy and safety of Mycophenolate mofetil versus intravenous Cyclophosphamide pulses in the treatment of crescentic IgA nephropathy		12 months	Yes