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Completed

NCT Number: NCT00301600

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

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

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Key information

Age range

12 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine

Nanjing, Jiangsu, 210002, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mycophenolate mofetil

Drug

MMF,1.0g/d

Other names: MMF,cellcept

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Nanjing University School of Medicine

Other

Registry information

Important dates

Study start
2003
Primary completion
2005
Study completion
2006
First posted
Mar 13, 2006
Registry last updated
May 27, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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