Rituximab Treatment of Focal Segmental Glomerulosclerosis

NCT00550342 | Withdrawn Phase 2 DMC FDA Drug

• 2 other identifiers: R21 DK77329 (completed)R21DK077329
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Focal Segmental Glomerulosclerosis (FSGS)

Keywords

Focal segmental glomerulosclerosis; FSGS; Proteinuria; rituximab; B cell; autoimmune; CD20; treatment; children

Outcome Measures

Primary Outcomes (1)

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

  One year

Secondary Outcomes (4)

• 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

  one year

• Number of subjects who develop a recurrence or increase of proteinuria on samples obtained at least 4 weeks apart

  one year

• Effect of treatment on PF levels

  one year

• Safety as measured by infections and drug infusion reactions.

  one year

Study Arms (1)

Rituximab

EXPERIMENTAL

Rituximab (375 mg/m2) will be administered intravenously as per current package label in a facility capable of handling infusion reactions. Subjects would be pre dosed with diphenhydramine and acetaminophen. Solu-Medrol, 1.5 mg/kg would be dosed 1 hour prior to the first dose of rituximab. Three subsequent doses of rituximab will be given at weekly intervals.

Drug: rituximab

Interventions

rituximab DRUG

375 mg/m2 intravenously for 4 doses

Also known as: Rituxan

Rituximab

Eligibility Criteria

• Age: 5 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): lead
• Genentech, Inc.: collaborator
• Indiana University: collaborator

Study Sites (1)

Indiana University

Indianapolis, Indiana, 46202, United States

Location

Related Publications (1)

• Pescovitz MD, Book BK, Sidner RA. Resolution of recurrent focal segmental glomerulosclerosis proteinuria after rituximab treatment. N Engl J Med. 2006 May 4;354(18):1961-3. doi: 10.1056/NEJMc055495. No abstract available.

  PMID: 16672715 BACKGROUND

MeSH Terms

Conditions

Glomerulosclerosis, Focal Segmental; Proteinuria

Interventions

Rituximab

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urination Disorders; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Mark D Pescovitz, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2007
• First Posted: October 29, 2007
• Study Start: January 1, 2008
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: May 6, 2025

Record last verified: 2012-04

Locations

US (1)