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Rituximab Treatment of Focal Segmental Glomerulosclerosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00550342
Recruitment Status : Completed
First Posted : October 29, 2007
Last Update Posted : September 13, 2017
Sponsor:
Collaborators:
Genentech, Inc.
Indiana University
Information provided by (Responsible Party):
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

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)

Condition or disease Intervention/treatment Phase
Focal Segmental Glomerulosclerosis (FSGS) Drug: rituximab Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Anti-CD20, Rituximab, for the Treatment of Recurrent or Primary Resistant Focal Segmental Glomerulosclerosis (FSGS)
Study Start Date : January 2008
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009


Arm Intervention/treatment
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




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

Secondary Outcome Measures :
  1. 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 ]
  2. Number of subjects who develop a recurrence or increase of proteinuria on samples obtained at least 4 weeks apart [ Time Frame: one year ]
  3. Effect of treatment on PF levels [ Time Frame: one year ]
  4. Safety as measured by infections and drug infusion reactions. [ Time Frame: one year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00550342


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

Publications:
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Responsible Party: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT00550342    
Other Study ID Numbers: R21 DK77329 (completed)
R21DK077329 ( U.S. NIH Grant/Contract )
First Posted: October 29, 2007    Key Record Dates
Last Update Posted: September 13, 2017
Last Verified: April 2012

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
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:
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Glomerulosclerosis, Focal Segmental
Glomerulonephritis
Nephritis
Kidney Diseases
Urologic Diseases
Rituximab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents