Rituximab Treatment of Focal Segmental Glomerulosclerosis

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT00550342
• Date of registration: 26/10/2007
• Prospective Registration: Yes
• Primary sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Public title: Rituximab Treatment of Focal Segmental Glomerulosclerosis
• Scientific title: Anti-CD20, Rituximab, for the Treatment of Recurrent or Primary Resistant Focal Segmental Glomerulosclerosis (FSGS)
• Date of first enrolment: January 2008
• Target sample size: 10
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00550342
• Study type: Interventional
• Study design: Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Mark D Pescovitz, MD
• Affiliation: Indiana University

Key inclusion & exclusion 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



Age minimum: 5 Years
Age maximum: 60 Years
Gender: All

Health Condition(s) or Problem(s) studied

Focal Segmental Glomerulosclerosis (FSGS)

Intervention(s)

Drug: rituximab

Primary Outcome(s)

The primary endpoint will be resolution of proteinuria defined as a Up/C ratio of <0.2. [Time Frame: One year]

Secondary Outcome(s)

Safety as measured by infections and drug infusion reactions. [Time Frame: one year]

Effect of treatment on PF levels [Time Frame: one year]

Number of subjects who develop a recurrence or increase of proteinuria on samples obtained at least 4 weeks apart [Time Frame: one year]

Number of subjects who achieve partial remission defined at a fall of 50% or more in the Up/C ratio from the pre-treatment baseline [Time Frame: one year]

Secondary ID(s)

R21DK077329

R21 DK77329 (completed)

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Genentech, Inc.

Indiana University