Rituximab for Pediatric Renal Transplant Rejection

NCT00697996 | Completed Phase 2

• 1 other identifier: SU-06102008-1196
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Rituximab will be tested for its safety and potential efficacy in treating B cell dense renal allograft rejection episodes in children receiving renal transplants at Stanford University

Conditions

Kidney Transplantation

Outcome Measures

Primary Outcomes (1)

• Rituximab safety in pediatric patients

Secondary Outcomes (1)

• resolution fo graft rejection

Interventions

Rituximab for transplant rejection DRUG

Eligibility Criteria

• Age: 5 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Pediatric renal allograft recipients aged 2-21 years with biopsy proven acute rejection episodes.
• Able and willing to give written informed consent and comply with the requirements of the study protocol (patients \>18 years of age or parents)
• Greater than 30% decline in baseline renal function as indicated by a rise in the serum creatinine.
• Adequate liver function, as indicated by AST or ALT \<2x upper limit of normal unless related to primary disease.
• Negative serum pregnancy test (for women of child bearing age)
• Men and women of reproductive potential must agree to use an acceptable method of birth control during treatment and for twelve months (1 year) after completion of treatment.\&#xA;

You may not qualify if:

• Treatment with any investigational agent within 4 weeks of screening or 5 half-lives of the investigational drug (whichever is longer)
• Receipt of a live vaccine within 4 weeks prior to randomization
• Previous Treatment with Rituximab (MabThera® / Rituxan®)
• History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
• History of HIV (positive HIV, HIV conducted during screening if applicable)
• History of Hepatitis B and/or Hepatitis C (Hep B/C at screening)
• History of recurrent significant infection or history of recurrent bacterial infections
• Known active bacterial, viral, fungal, mycobacterial, or other infection (including tuberculosis or atypical mycobacterial disease, but excluding fungal infections of nail beds) or any major episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks prior to screening
• Ongoing use of high dose steroids (\>10mg/day) or unstable steroid dose in the past 4 weeks.
• Lack of peripheral venous access
• History of drug, alcohol, or chemical abuse within 6 months prior to screening
• Pregnancy (a negative serum pregnancy test should be performed for all women of childbearing potential within 7 days of treatment) or lactation
• Concomitant malignancies or previous malignancies within the last five years, with the exception of adequately treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.
• History of psychiatric disorder
• Significant cardiac or pulmonary disease (including obstructive pulmonary disease)

Sponsors & Collaborators

• Stanford University: lead
• Genentech and Biogen IDEC: collaborator

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Interventions

Rituximab; Graft Rejection

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Host vs Graft Reaction; Transplantation Immunology; Immune System Phenomena

Study Officials

• Minnie M. Sarwal

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 11, 2008
• First Posted: June 16, 2008
• Study Start: June 1, 2005
• Study Completion: August 1, 2007
• Last Updated: December 23, 2008

Record last verified: 2008-12

Locations

US (1)