Use of Belatacept During Post Depletional Repopulation to Facilitate Tolerance in Renal Allograft Recipients
18 Years
N/A
Both
Organ Transplantation
Trial Information
Use of Belatacept During Post Depletional Repopulation to Facilitate Tolerance in Renal Allograft Recipients
This study will be a single-center, open-label,proof of concept study in non-HLA-identical
living and deceased donor renal transplants. The initial 20 subjects were randomized to
either receive/not to receive a single donor bone marrow infusion in addition to the
investigational combination of alemtuzumab, belatacept, and sirolimus. Since the bone marrow
infusion has been eliminated in the second group of 20 subjects, no randomization will be
required. All recipients in the second group of 20 subjects will receive the same
investigational combination of alemtuzumab, belatacept, and sirolimus.
At the time of transplant, participants will receive a 3-hour IV infusion of 30 mg. of
alemtuzumab. Participants will receive a combination of sirolimus and belatacept for at
least 1 year. At that time, eligible participants will consent to and begin oral
immunosuppressive withdrawal or continue therapy through study close. Sirolimus will first
be weaned by halving the dose and/or increasing the dosing interval over at least a 2-6
month period. After sirolimus is discontinued, participants will remain on monthly IV
belatacept monotherapy indefinitely.
Follow-up will continue for at least five years. If subjects are successfully weaned from
oral immunosuppression during their participation in this trial, no other alternative
therapy will be warranted. Since belatacept is now FDA approved, subjects will be eligible
to continue this therapy after their study participation has ended.
Inclusion Criteria:
- Recipients age 18 or older of an HLA-non-identical,living or deceased donor kidney
transplant.
- A willing renal donor who consents for subsequent donation of donor blood for testing
throughout the follow-up period and for use of his/her kidney in this experimental
study.
Exclusion Criteria:
- Immunosuppressive drug therapy within 1 year prior to enrollment.
- Active malignancy or history of malignancy within 5 years of enrollment.
- Any history of blood malignancy or lymphoma.
- Any known immunodeficiency syndrome, including HIV infection.
- Absence of EBV or CMV specific antibodies in cases with evidence of EBV and/or CMV
infection.
- Women of child-bearing potential unwilling or unable to use an acceptable method of
birth control.
- Women who are pregnant or breastfeeding at the time of enrollment or study drug
administration.
- Donor age <18 years.
- Subjects with protocol-specific etiologies of underlying renal disease.
- Subjects with a positive T-cell lymphocytic crossmatch or historical evidence of
donor specific alloantibody by solid phase or flow-based detection methods.
- Prior solid organ transplant or potential to require a concurrent organ or cell
transplant.
- Positive Hepatitis B or C antibodies and PCR positive for the same.
- Active (tuberculosis) TB requiring treatment within the previous 3 years.
- Known positive PPD unless chest x-ray is negative or treatment for latent TB has been
completed.
- Active infection or other contraindications.
- History of drug or alcohol abuse within the past 5 years.
- Psychotic disorders which would interfere with adequate study follow-up.
- Active peptic ulcer disease, chronic diarrhea, or gastric malabsorption.
- All women 40 years or older with first degree family history of breast cancer will be
required to have a screening mammogram within 6 months of study enrollment.
- Subjects with suspicion of breast malignancy which cannot be ruled out will be
excluded.
- Belatacept use within 30 days prior to the day 1 visit.
- Prisoners or individuals who are involuntarily incarcerated.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
The primary endpoint will be the number of patients successfully withdrawn from oral immunosuppression for one year after their last dose of an immunosuppressive drug.
Outcome Time Frame:
Prospective
Safety Issue:
Yes
Principal Investigator
Allan D. Kirk, M.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Emory University
Authority:
United States: Food and Drug Administration
Study ID:
BMS IM103-036
NCT ID:
NCT00565773
Start Date:
December 2007
Completion Date:
December 2019
Related Keywords:
- Organ Transplantation
Name | Location |
|---|---|
| The Emory Clinic | Atlanta, Georgia 30322 |
| Emory University Hospital | Atlanta, Georgia 30322 |
