Rituximab and Intravenous Immunoglobulin (IVIG) for Desensitization in Renal Transplantation

NCT00642655 | Completed Phase 1

• 1 other identifier: U3176s
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to examine the safety and efficacy of IVIG in combination with Rituximab to lower the level of HLA-sensitive antibodies and block their ability to attack a transplanted organ in patients who are highly HLA-sensitized and are awaiting transplantation.

Conditions

Kidney Transplant

Keywords

IVIG; Rituximab; Highly Sensitized; Kidney Transplantation

Outcome Measures

Primary Outcomes (1)

• Success of transplantation

  12 months

Secondary Outcomes (1)

• Number and severity of rejection episodes

  12

Interventions

IVIG and Rituximab DRUG

IVIG 2gm/kg given intravenously on day#0 and day#30 Rituximab 1gm given intravenously on day#7 and day#22

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients eligible for the study will be those who have anti-HLA antibody (Panel Reactive Antibody \[PRA\]) of \>30% and are eligible for transplantation at Cedars-Sinai Medical Center. We currently anticipate entering 20 patients over the course of the study. We currently have \~100 patients on our wait list that would meet the above criteria. Patients will be selected based on the ability of IVIG to inhibit the cytotoxic anti-HLA antibody activity in vitro. They will then receive IVIG 2gm/kg X1 on day 1 while on hemodialysis. Seven days later, the patients will receive Rituxan® 1gm in the CSMC Cancer Infusion Center as per protocol for Rituxan® infusion. The second Rituxan® infusion will be on day#22. The patients will have monitoring of anti-HLA antibody and outlined tests as shown above.
• Able and willing to give written informed consent and comply with the requirements of the study protocol
• Adequate liver function, as indicated by normal liver function tests (NL: AST, ALT, Bilirubin and negative tests for hepatitis C and hepatitis B.
• 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.

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®)
• Prior antibody therapy
• History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
• History of HIV (positive HIV, HIV conducted during screening)
• History of Hepatitis B and/or Hepatitis C
• 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 i.v. antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks prior to screening
• 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

• Cedars-Sinai Medical Center: lead
• Genentech, Inc.: collaborator
• Biogen: collaborator

Study Sites (1)

8700 Beverly Blvd.

Los Angeles, California, 90048, United States

Location

Related Publications (1)

• Vo AA, Lukovsky M, Toyoda M, Wang J, Reinsmoen NL, Lai CH, Peng A, Villicana R, Jordan SC. Rituximab and intravenous immune globulin for desensitization during renal transplantation. N Engl J Med. 2008 Jul 17;359(3):242-51. doi: 10.1056/NEJMoa0707894.

  PMID: 18635429 DERIVED

MeSH Terms

Interventions

Immunoglobulins, Intravenous; Rituximab

Intervention Hierarchy (Ancestors)

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

Study Officials

• Stanley C. Jordan, MD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

• Ashley A Vo, PharmD

  Cedars-Sinai Medical Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 19, 2008
• First Posted: March 25, 2008
• Study Start: September 1, 2005
• Primary Completion: May 1, 2007
• Study Completion: May 1, 2007
• Last Updated: March 25, 2008

Record last verified: 2008-03

Locations

US (1)