Overview

Rituximab Treatment of Focal Segmental Glomerulosclerosis

Status:
Completed

Trial end date:
2009-12-01

Target enrollment:
0

Participant gender:
All

Summary

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

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

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

Collaborators:

Genentech, Inc.
Indiana University

Treatments:

Rituximab

Criteria

Inclusion Criteria:

1. 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

2. Estimated GFR ≥ 40 ml/min/1.73 m2

3. Up/c > 1.0 g protein/g creatinine on first am void

4. 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.

5. Steroid resistance as defined by primary physician

6. If participant is female with reproductive potential, she must be willing to avoid
pregnancy and have a negative pregnancy test

7. At least one month from last immunization received

Exclusion Criteria:

1. Are immunodeficient or have clinically significant chronic lymphopenia

2. Have an active infection or positive PPD test result

3. Be currently pregnant or lactating, or anticipate getting pregnant

4. Have serologic evidence of current or past HIV, Hepatitis B, or Hepatitis C infection

5. Have any complicating medical issues that interfere with study conduct or cause
increased risk

6. Have a history of malignancies within the last five years except for adequately
treated skin cancer

7. Have severe cardiac problems such as angina or medically treated arrythmia