Mycophenolate Mofetil Versus Intravenous Cyclophosphamide Pulses in the Treatment of Crescentic IgA Nephropathy
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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 | Intervention |
|---|---|
|
IGA Nephropathy |
Drug: Mycophenolate mofetil |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Mycophenolate Mofetil Versus Intravenous Cyclophosphamide Pulses in the Treatment of Crescentic IgA Nephropathy |
- To compare the efficacy and safety of Mycophenolate mofetil versus intravenous Cyclophosphamide pulses in the treatment of crescentic IgA nephropathy [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
| Enrollment: | 40 |
| Study Start Date: | January 2003 |
| Study Completion Date: | January 2006 |
| Primary Completion Date: | May 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Mycophenolate mofeti |
Drug: Mycophenolate mofetil
MMF,1.0g/d
Other Name: MMF,cellcept
|
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| Ages Eligible for Study: | 12 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| China, Jiangsu | |
| Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine | |
| Nanjing, Jiangsu, China, 210002 | |
| Study Chair: | Lei-Shi Li, M.D. | Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine |
More Information
No publications provided
| Responsible Party: | Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine, Nanjing University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT00301600 History of Changes |
| Other Study ID Numbers: | NJCT-0606 |
| Study First Received: | March 10, 2006 |
| Last Updated: | May 25, 2010 |
| Health Authority: | China: Food and Drug Administration |
Keywords provided by Nanjing University School of Medicine:
|
Crescentic IgA nephropathy Mycophenolate mofetil Cyclophosphamide treatment |
Additional relevant MeSH terms:
|
Glomerulonephritis, IGA Kidney Diseases Glomerulonephritis Nephritis Urologic Diseases Autoimmune Diseases Immune System Diseases Cyclophosphamide Mycophenolate mofetil Mycophenolic Acid Immunosuppressive Agents Immunologic Factors |
Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Antibiotics, Antineoplastic Enzyme Inhibitors |
ClinicalTrials.gov processed this record on May 16, 2013