Trial record 3 of 5 for:    Rituximab and Intravenous Immunoglobulin (IVIG) for Desensitization in Renal Transplantation

Desensitization of Highly Sensitized Deceased Donor Renal Transplantation Candidates

This study has been completed.
Information provided by:
Johns Hopkins University Identifier:
First received: September 29, 2009
Last updated: August 17, 2011
Last verified: August 2011

Some patients who need kidney transplants have high levels of antibodies that make them incompatible with most potential deceased donor kidney offers. These patients are considered highly-sensitized and are very difficult to transplant because the likelihood that they will receive a compatible organ is very low. There are some medications and procedures that can decrease the antibody levels and this can increase the chance of finding a compatible donor for these patients. In this study the investigators will give two medications (IVIg and Rituximab) to highly-sensitized patients who are on the waiting list for a deceased donor kidney transplant. After the investigators administer these medications, the investigators will continue to check for compatibility as organ offers are received. If a compatible organ offer is received, the investigators will perform the transplant using that organ. The investigators hypothesize that these medications will lower antibody levels and increase the chance that a these patients are able to receive a compatible kidney transplant.

Condition Intervention Phase
Kidney Failure
Drug: IVIg and rituximab
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 2 Study of IVIg and Rituximab for Desensitization of Highly Sensitized Deceased Donor Renal Transplantation Candidates

Resource links provided by NLM:

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Time to kidney transplantation [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Decrease in panel reactive antibody [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Enrollment: 27
Study Start Date: September 2009
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: IVIg and rituximab

    A maximum of four doses (each single dose being 2gm/kg) of IVIg will be administered over a four-month period, with one dose administered each month. Each single dose of 2gm/kg will be administered in two half-doses (1gm/kg each) to be given one day apart, with one day of hemodialysis on the intervening day between the two half-doses.

    If a compatible kidney transplant organ offer is received, upon admission to the hospital and immediately prior to the transplant operation, patients will receive a single infusion of Rituximab (375 mg/m2 BSA).

    Other Name: Gammunex and Rituxan

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Ages 18-75
  • End-stage renal disease on dialysis
  • PRA > 60%
  • Have been evaluated for and are currently listed for deceased donor renal transplantation

Exclusion Criteria:

  • Have contraindication to transplantation
  • Have contraindication to receiving IVIG
  • Have allergy to IVIG
  • Have received IVIG for desensitization previously without effect
  • Pregnant women or those intending to become pregnant
  Contacts and Locations
Please refer to this study by its identifier: NCT00986947

United States, Maryland
Johns Hopkins Medical Institutions
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
Johns Hopkins University
  More Information

No publications provided

Responsible Party: Andrew L. Singer, Johns Hopkins University Identifier: NCT00986947     History of Changes
Other Study ID Numbers: NA_00027111
Study First Received: September 29, 2009
Last Updated: August 17, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Immunoglobulins, Intravenous
Urologic Diseases
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents processed this record on April 17, 2014