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Desensitization of Highly Sensitized Deceased Donor Renal Transplantation Candidates

This study has been terminated.
Information provided by (Responsible Party):
Johns Hopkins University Identifier:
First received: September 29, 2009
Last updated: May 1, 2017
Last verified: May 2017
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: Intervention Model: Single Group Assignment
Masking: None (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 ]

Secondary Outcome Measures:
  • Decrease in Panel Reactive Antibody [ Time Frame: 4 months ]

Enrollment: 20
Study Start Date: September 2009
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IvIg with Rituximab 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: Gamunex and Rituxan


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Ages 18-75
  • End-stage renal disease on dialysis
  • Panel Reactive Antibody (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
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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

Responsible Party: Johns Hopkins University Identifier: NCT00986947     History of Changes
Other Study ID Numbers: NA_00027111
Study First Received: September 29, 2009
Results First Received: March 21, 2017
Last Updated: May 1, 2017

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents processed this record on August 17, 2017