Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Desensitization of Highly Sensitized Deceased Donor Renal Transplantation Candidates

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00986947
Recruitment Status : Terminated
First Posted : September 30, 2009
Results First Posted : June 1, 2017
Last Update Posted : June 1, 2017
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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 or disease Intervention/treatment Phase
Kidney Failure Drug: IVIg and rituximab Phase 2

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
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
Study Start Date : September 2009
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Rituximab

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Time to Kidney Transplantation [ Time Frame: 4 months ]

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

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00986947


Locations
Layout table for location information
United States, Maryland
Johns Hopkins Medical Institutions
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
Johns Hopkins University
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00986947    
Other Study ID Numbers: NA_00027111
First Posted: September 30, 2009    Key Record Dates
Results First Posted: June 1, 2017
Last Update Posted: June 1, 2017
Last Verified: May 2017
Additional relevant MeSH terms:
Layout table for MeSH terms
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Rituximab
Antineoplastic Agents, Immunological
 Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents