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

Study Description

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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

Condition or disease	Intervention/treatment	Phase
IGA Nephropathy	Drug: Mycophenolate mofetil	Not Applicable

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.

Study Design

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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

Arms and Interventions

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Arm	Intervention/treatment
Active Comparator: Mycophenolate mofeti	Drug: Mycophenolate mofetil; MMF,1.0g/d; Other Name: MMF,cellcept

Outcome Measures

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Primary Outcome Measures :

1. To compare the efficacy and safety of Mycophenolate mofetil versus intravenous Cyclophosphamide pulses in the treatment of crescentic IgA nephropathy [ Time Frame: 12 months ]

Eligibility Criteria

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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

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

Contacts and Locations

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Locations

China, Jiangsu
Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine
Nanjing, Jiangsu, China, 210002

Sponsors and Collaborators

Nanjing University School of Medicine

Investigators

Study Chair:	Lei-Shi Li, M.D.	Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine

More Information

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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
First Posted:	March 13, 2006
Last Update Posted:	May 27, 2010
Last Verified:	July 2008

Keywords provided by Nanjing University School of Medicine:

Crescentic IgA nephropathy; Mycophenolate mofetil; Cyclophosphamide; treatment

Additional relevant MeSH terms:

Kidney Diseases; Glomerulonephritis, IGA; Urologic Diseases; Glomerulonephritis; Nephritis; Autoimmune Diseases; Immune System Diseases; Cyclophosphamide; Mycophenolic Acid; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs	Antirheumatic Agents; Antineoplastic Agents, Alkylating; Alkylating Agents; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Myeloablative Agonists; Antibiotics, Antineoplastic; Antibiotics, Antitubercular; Antitubercular Agents; Anti-Bacterial Agents; Anti-Infective Agents; Enzyme Inhibitors