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

This study has been completed.
Sponsor:
Information provided by:
Nanjing University School of Medicine
ClinicalTrials.gov Identifier:
NCT00301600
First received: March 10, 2006
Last updated: May 25, 2010
Last verified: July 2008
  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:


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

  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
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 November 24, 2014