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Rituximab Treatment of Focal Segmental Glomerulosclerosis

This study has been completed.
Sponsor:
Collaborator:
Genentech
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00550342
First received: October 26, 2007
Last updated: April 12, 2012
Last verified: April 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Focal Segmental Glomerulosclerosis (FSGS)
 Drug: rituximab
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Anti-CD20, Rituximab, for the Treatment of Recurrent or Primary Resistant Focal Segmental Glomerulosclerosis (FSGS)

Resource links provided by NLM:

Drug Information available for: Rituximab
U.S. FDA Resources

Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Primary Outcome Measures:
  • The primary endpoint will be resolution of proteinuria defined as a Up/C ratio of <0.2. [ Time Frame: One year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Number of subjects who develop a recurrence or increase of proteinuria on samples obtained at least 4 weeks apart [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Effect of treatment on PF levels [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Safety as measured by infections and drug infusion reactions. [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 10
Study Start Date: January 2008
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rituximab
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
375 mg/m2 intravenously for 4 doses
Other Name: Rituxan

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   5 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00550342

Locations
United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Genentech
Investigators
Principal Investigator: Mark D Pescovitz, MD Indiana University
  More Information

Publications:

Responsible Party: Mark Pescovitz MD/Professor of Surgery and Microbiology/Immunology, Indiana University School of Medicine
ClinicalTrials.gov Identifier: NCT00550342     History of Changes
Other Study ID Numbers: R21 DK77329 (completed), 1 R21 DK077329-01A1
Study First Received: October 26, 2007
Last Updated: April 12, 2012
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
Focal segmental glomerulosclerosis
FSGS
Proteinuria
rituximab
B cell
 autoimmune
CD20
treatment
children

Additional relevant MeSH terms:
Glomerulosclerosis, Focal Segmental
Glomerulonephritis
Nephritis
Kidney Diseases
Urologic Diseases
Rituximab
 Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents

ClinicalTrials.gov processed this record on May 22, 2013