WithdrawnPhase 2

Rituximab Treatment of Focal Segmental Glomerulosclerosis

Stopped: Problems with drug supply

United States0Started 2008-01

Plain-language summary

The purpose of this study is to determine whether the approved drug, rituximab, is effective in the treatment of focal segmental glomerulosclerosis (FSGS)

Who can participate

Age range5 Years – 60 Years

SexALL

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Inclusion criteria

✓. Primary FSGS involving either native kidneys or primary FSGS recurring after renal transplantation. Age 5-60 years at onset of signs or symptoms of FSGS
✓. Estimated GFR ≥ 40 ml/min/1.73 m2
✓. Up/c \> 1.0 g protein/g creatinine on first am void
✓. Biopsy confirmed as primary FSGS (including all subtypes). At least 1 glomerulus demonstrating segmental sclerosis or minimal change FSGS or idiopathic mesangial proliferation with negative immunostains by light microscopy and no dense deposits on electron microscopy. Biopsy required but can be normal for those subjects with rapid recurrence of post transplant FSGS.
✓. Steroid resistance as defined by primary physician
✓. If participant is female with reproductive potential, she must be willing to avoid pregnancy and have a negative pregnancy test
✓. At least one month from last immunization received

Exclusion criteria

✕. Are immunodeficient or have clinically significant chronic lymphopenia
✕. Have an active infection or positive PPD test result
✕. Be currently pregnant or lactating, or anticipate getting pregnant
✕. Have serologic evidence of current or past HIV, Hepatitis B, or Hepatitis C infection
✕. Have any complicating medical issues that interfere with study conduct or cause increased risk
✕. Have a history of malignancies within the last five years except for adequately treated skin cancer
✕. Have severe cardiac problems such as angina or medically treated arrythmia

What they're measuring

The primary endpoint will be resolution of proteinuria defined as a Up/C ratio of <0.2.

Timeframe: One year

Trial details

NCT IDNCT00550342

SponsorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2009-12

View on ClinicalTrials.gov More Focal Segmental Glomerulosclerosis (FSGS) trials