A Study to Evaluate the Safety of Rituximab Retreatment in Subjects With Lupus Nephritis Previously Enrolled in Study U2970g

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
Genentech
ClinicalTrials.gov Identifier:
NCT00404157
First received: November 22, 2006
Last updated: January 28, 2008
Last verified: January 2008
  Purpose

This is a Phase III, multicenter, extension study to evaluate the safety of rituximab administered on a scheduled basis approximately every 6 months. All subjects who complete their Week 52 visit in Study U2970g will be eligible for this study, as long as the inclusion and exclusion criteria are met.


Condition Intervention Phase
Lupus Nephritis
Drug: Rituximab
Phase 3

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Phase III, Extension Study to Evaluate the Safety of Rituximab Retreatment in Subjects With ISN/RPS 2003 Class III or IV Lupus Nephritis Previously Enrolled in Study U2970g

Resource links provided by NLM:


Further study details as provided by Genentech:

Primary Outcome Measures:
  • Safety will be monitored through regular physical examinations, vital signs, hematologic laboratory tests, urinalyses, and incidence and severity of adverse events.

Secondary Outcome Measures:
  • Proportion of subjects who maintain a CRR achieved at Week 52 in Study U2970g
  • Serum rituximab levels
  • Circulating B-cell counts.

Estimated Enrollment: 140
  Eligibility

Ages Eligible for Study:   16 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ability and willingness to provide written informed consent and comply with the requirements of the study protocol
  • Participation in Study U2970g and completion of the Week 52 visit in that study
  • For subjects of reproductive potential (males and females), use of a reliable means of contraception throughout their study participation

Exclusion Criteria:

  • Discontinuation or withdrawal from Study U2970g or failure to complete the Week 52 visit
  • Any safety concern potentially attributable to rituximab that in the investigator's opinion may jeopardize subject safety
  • In the investigator's opinion, lack of any clinical improvement by Week 52 in Study U2970g and for whom the proposed therapy would represent risk without benefit
  • Current thrombocytopenia or at high risk for developing clinically significant bleeding or organ dysfunction requiring therapies such as plasmapheresis or acute blood or platelet transfusions
  • Lack of peripheral venous access
  • Pregnancy or lactation
  • History of severe, allergic, or anaphylactic reactions to humanized or murine monoclonal antibodies
  • Significant new or uncontrolled disease in any organ system not related to SLE (e.g., poorly controlled chronic obstructive pulmonary disease or asthma, cardiovascular disease, accelerated hypertension, major depression) that in the investigator's opinion would preclude subject participation
  • Known active infection of any kind (excluding fungal infection of nail beds), any major episode of infection requiring hospitalization, or treatment with IV antibiotics within 4 weeks of a study drug infusion or oral antibiotics within 2 weeks of a study drug infusion
  • History of cancer, including solid tumors, hematologic malignancies, and carcinoma in situ
  • Major surgery within 4 weeks prior to screening
  • Intolerance or contraindication to oral or IV corticosteroids
  • Lipase > 2 x the upper limit of normal (ULN)
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) > 2.5 x the ULN
  • Amylase levels > 2 x the ULN
  • Absolute neutrophil counts < 1.5 x 10^3/uL
  • History of positive hepatitis B surface antigen or hepatitis C serology
  • Hemoglobin < 7 g/dL unless caused by autoimmune hemolytic anemia resulting from SLE
  • Platelet count < 10,000/uL
  • Receipt of a live vaccine within 28 days prior to treatment
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00404157

Sponsors and Collaborators
Genentech
Investigators
Study Director: Jay Garg, M.D. Genentech
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00404157     History of Changes
Other Study ID Numbers: U3388g
Study First Received: November 22, 2006
Last Updated: January 28, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Genentech:
Lupus
U2970g

Additional relevant MeSH terms:
Lupus Nephritis
Nephritis
Glomerulonephritis
Kidney Diseases
Urologic Diseases
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Rituximab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents

ClinicalTrials.gov processed this record on August 25, 2014