Mycophenolate Mofetil Versus Intravenous Cyclophosphamide Pulses in the Treatment of Crescentic IgA Nephropathy - Full Text View

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

Resource links provided by NLM:

MedlinePlus related topics: Kidney Diseases

Drug Information available for: Cyclophosphamide Mycophenolic acid Mycophenolate sodium Mycophenolate mofetil hydrochloride Mycophenolate mofetil Immunoglobulin A

Genetic and Rare Diseases Information Center resources: Berger Disease Glomerulonephritis

U.S. FDA Resources

Further study details as provided by Nanjing University School of Medicine:

Primary Outcome Measures:

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

Criteria

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00301600

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

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 Autoimmune Diseases Glomerulonephritis Immune System Diseases Nephritis Urologic Diseases Cyclophosphamide Mycophenolate mofetil Mycophenolic Acid Alkylating Agents Antibiotics, Antineoplastic	Antineoplastic Agents Antineoplastic Agents, Alkylating Antirheumatic Agents Enzyme Inhibitors Immunologic Factors Immunosuppressive Agents Molecular Mechanisms of Pharmacological Action Myeloablative Agonists Pharmacologic Actions Physiological Effects of Drugs Therapeutic Uses

ClinicalTrials.gov processed this record on February 27, 2015