Mycophenolate Mofetil Versus Intravenous Cyclophosphamide Pulses in the Treatment of Crescentic IgA Nephropathy
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ClinicalTrials.gov Identifier: NCT00301600 |
Recruitment Status :
Completed
First Posted : March 13, 2006
Last Update Posted : May 27, 2010
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
IGA Nephropathy | Drug: Mycophenolate mofetil | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 40 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Mycophenolate Mofetil Versus Intravenous Cyclophosphamide Pulses in the Treatment of Crescentic IgA Nephropathy |
Study Start Date : | January 2003 |
Actual Primary Completion Date : | May 2005 |
Actual Study Completion Date : | January 2006 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Mycophenolate mofeti |
Drug: Mycophenolate mofetil
MMF,1.0g/d
Other Name: MMF,cellcept |
- To compare the efficacy and safety of Mycophenolate mofetil versus intravenous Cyclophosphamide pulses in the treatment of crescentic IgA nephropathy [ Time Frame: 12 months ]

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Ages Eligible for Study: | 12 Years to 65 Years (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00301600
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 |
Responsible Party: | Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine, Nanjing University School of Medicine |
ClinicalTrials.gov Identifier: | NCT00301600 |
Other Study ID Numbers: |
NJCT-0606 |
First Posted: | March 13, 2006 Key Record Dates |
Last Update Posted: | May 27, 2010 |
Last Verified: | July 2008 |
Crescentic IgA nephropathy Mycophenolate mofetil Cyclophosphamide treatment |
Kidney Diseases Glomerulonephritis, IGA Urologic Diseases Glomerulonephritis Nephritis Autoimmune Diseases Immune System Diseases Mycophenolic Acid |
Antibiotics, Antineoplastic Antineoplastic Agents Antibiotics, Antitubercular Antitubercular Agents Anti-Bacterial Agents Anti-Infective Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |