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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00301600
Recruitment Status : Completed
First Posted : March 13, 2006
Last Update Posted : May 27, 2010
Sponsor:
Information provided by:
Nanjing University School of Medicine

Tracking Information
First Submitted Date  ICMJE March 10, 2006
First Posted Date  ICMJE March 13, 2006
Last Update Posted Date May 27, 2010
Study Start Date  ICMJE January 2003
Actual Primary Completion Date May 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 27, 2007)
To compare the efficacy and safety of Mycophenolate mofetil versus intravenous Cyclophosphamide pulses in the treatment of crescentic IgA nephropathy [ Time Frame: 12 months ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Mycophenolate Mofetil Versus Intravenous Cyclophosphamide Pulses in the Treatment of Crescentic IgA Nephropathy
Official Title  ICMJE Mycophenolate Mofetil Versus Intravenous Cyclophosphamide Pulses in the Treatment of Crescentic IgA Nephropathy
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
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE IGA Nephropathy
Intervention  ICMJE Drug: Mycophenolate mofetil
MMF,1.0g/d
Other Name: MMF,cellcept
Study Arms  ICMJE Active Comparator: Mycophenolate mofeti
Intervention: Drug: Mycophenolate mofetil
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 10, 2006)
40
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2006
Actual Primary Completion Date May 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 65 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00301600
Other Study ID Numbers  ICMJE NJCT-0606
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine, Nanjing University School of Medicine
Study Sponsor  ICMJE Nanjing University School of Medicine
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Lei-Shi Li, M.D. Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine
PRS Account Nanjing University School of Medicine
Verification Date July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP