Desensitization Before Kidney Transplant Clinical Trial
Official title:
One Year Exploratory Study to Evaluate the Efficacy and Safety of Belimumab for Normalization of Alloantibody Levels in Sensitized Patients Awaiting Kidney Transplantation
| Verified date | January 2012 |
| Source | University of Pennsylvania |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
If subjects are listed for kidney transplant and are considered sensitized, this means they have a high amount of antibodies in their blood that could react to a kidney transplant offered for them. Antibodies are protein substances made by the body that fight anything that the body considers as a threat to it, such as infection or a kidney transplant. Sensitization may be due to prior transplants, pregnancy, or blood transfusions. Being sensitized can increase the subject's kidney transplant waiting time as it is more difficult to find a suitable kidney transplant for them that their antibodies will not react to. The purpose of this research study is to see if giving the investigational drug belimumab up to one year pre-transplant can de-sensitize the subjects, or decrease the amount of antibodies in their blood. This may help make the subjects eligible to receive a kidney transplant more quickly. If after receiving belimumab, the subjects are compatible with a donor kidney offered and are medically suitable for transplant at that time, a kidney transplant will be performed.
| Status | Terminated |
| Enrollment | 8 |
| Est. completion date | January 2012 |
| Est. primary completion date | October 2011 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 75 Years |
| Eligibility |
Inclusion Criteria: - Male or female patients aged 18 -75 years. - Patients denied a kidney transplant because of a prior positive crossmatch - Patients awaiting a first or second kidney transplant from a living or deceased donor - Patients who have given written informed consent to participate in all aspects of the study. - Patients with no potential living donors should have accumulated at least 12 months waiting time in our organ procurement organization - And one of the following criteria: - Pre-sensitized patients defined by Luminex antibody assays and whose panel reactive antibody (PRA) is 20% or greater - Patients with a PRA of less than 20% but who have HLA antibody specificities to HLA-Cw, DP or allele-specific antigens Exclusion Criteria: - Patients with known hypersensitivity to belimumab or who have received biologics, within the last 90 days - Patients receiving corticosteroids, intravenous immunoglobulin, cyclophosphamide, mycophenolate mofetil, or azathioprine from 90 days prior to study entry until day of transplant. - Patients with a history of anaphylaxis to parenteral administration of contrast agents, foreign proteins, or monoclonal antibodies. - Patients with multi-organ transplant - Patients who have received any investigational immunosuppressive drug within 1 month of inclusion into this study or if use of such a product is anticipated. - Patients who have received any live vaccine within 30 days of study entry. - Female patients who are pregnant, lactating. - Female patients of child bearing potential and not willing to practice an approved method of birth control for 1 month prior to the start of the study agent and 8 weeks after the last dose of study agent. - Male patients who are not agreeable to using effective contraception throughout the study and for 3 months after the last dose of study agent. - Patients with a known malignancy or history of malignancy other than excised basal or squamous cell carcinoma of the skin. - Patients who are positive for Hepatitis B infection, Hepatitis C infection or Human Immunodeficiency Virus (HIV)-positive patients. - Patients with evidence of severe liver disease, including abnormal liver profile tests > 3 times upper limit of normal at screening. - Patients with current severe infection. - Patients with any surgical or medical condition, which in the opinion of the investigator precludes enrollment in this trial - Patients who live far from the transplant center and are unable to comply with all study visits. |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | University of Pennsyvlania Kidney Transplant Program | Philadelphia | Pennsylvania |
| Lead Sponsor | Collaborator |
|---|---|
| University of Pennsylvania | Human Genome Sciences Inc. |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | To assess the effectiveness of belimumab for decreasing antibody levels in sensitized patients awaiting kidney transplantation. | up to one year pre-transplant | No | |
| Primary | To determine whether reduction in antibody levels by belimumab therapy permits subsequent successful kidney transplantation from a cross-match compatible donor. | up to one year pre-transplant | No | |
| Secondary | To describe the pharmacokinetics of belimumab in sensitized patients awaiting kidney transplantation. | up to one year pre-transplant | Yes | |
| Secondary | To assess the safety of belimumab in sensitized patients awaiting kidney transplant | up to one year pre-transplant | Yes |