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Sponsors and Collaborators: |
Emory University Bristol-Myers Squibb FDA Office of Orphan Products Development |
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Information provided by: | Emory University |
ClinicalTrials.gov Identifier: | NCT00565773 |
Acute rejection is a common problem after a kidney transplant. Rejection can occur when the kidney recipient's immune system tries to attack (or reject) the new kidney. Rejection typically most often develops in the first few months after a transplant.
This single center study will seek to determine if a new combination of anti-rejection medications(including one investigational drug called Belatacept) is better than the current standard anti-rejection drug regimen at preventing rejection. Also to be determined will be whether the new combination of drugs will allow participants to wean off their anti-rejection medications over time, and become tolerant.
This study will test the safety and effectiveness of a new investigational drug combination using alemtuzumab, belatacept and sirolimus when given with or without donor bone marrow.
This combination of medicines has not been tested before in humans. Alemtuzumab (Campath) is approved for use in some types of white blood cell cancers, but is considered investigational in transplant patients. Belatacept is also an investigational drug being studied in transplant patients. Sirolimus (Rapamune) is approved for use in transplant patients, but its use with belatacept and alemtuzumab is investigational.
Half of the patients enrolled in this study will test whether an infusion of bone marrow from the kidney donor will improve the effect of these drugs.
Bone marrow infusion is also considered investigational.
Condition | Intervention | Phase |
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Organ Transplantation |
Drug: Belatacept Drug: Alemtuzumab Other: donor bone marrow |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Use of Belatacept During Post Depletional Repopulation to Facilitate Tolerance in Renal Allograft Recipients |
Estimated Enrollment: | 20 |
Study Start Date: | December 2007 |
Estimated Study Completion Date: | December 2013 |
Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
All patients will be given a single dose of alemtuzumab on the day of transplantation. All patients will receive belatacept and sirolimus for 1 year. Ten patients will receive a single dose of donor bone marrow 7 days after transplantation. At the time of transplant, all patients will receive a single dose of 500 mg of methylprednisolone IV over 30 minutes followed within 1 hour by an IV infusion of 30 mg. of alemtuzumab over 3 hours. |
Drug: Belatacept
Belatacept will be given as an IV infusion of 10mg /kg over 30 minutes. This will be repeated on study days 4 and 8 (prior to bone marrow infusion) and 15 then every 2 weeks for 4 additional doses. After week 24, belatacept will be given at a dose of 5 mg/kg once every 4 weeks until the drug is weaned.
Drug: Alemtuzumab
All patients will receive a single dose of 30 mgs. on the day of transplantation.
Other: donor bone marrow
The bone marrow will be given as an IV infusion over 3 hours on postoperative day 7 (study day 8). The formulated dose will be 1 x 10(8th power) unfractionated nucleated cells/kg recipient ideal body weight. A proposed total of twenty patients will be enrolled in this study. Half of the recipients will be randomized to receive the donor bone marrow infusion. Half of the recipients will not receive the infusion. bone marrow infusion. |
2: Experimental
All patients will be given a single dose of alemtuzumab on the day of transplantation. all patients will receive belatacept and sirolimus for one year. This group will not receive an infusion of donor bone marrow. At the time of transplant, all patients will receive a single dose of 500 mg of methylprednisolone IV over 30 minutes, followed within 1 hour by an IV infusion of 30 mg of alemtuzumab over 3 hours. |
Drug: Belatacept
Belatacept will be given as an IV infusion at 10mg/kg over 30 minutes on the day of transplantation. This dose will be repeated on study days 4, 8, and 15, then every 2 weeks for 4 additional doses. After week 24, belatacept will be given as an infusion of 5 mg/kg once every 4 weeks until the drug is weaned.
Drug: Alemtuzumab
All patients will receive a single dose of 30 mgs. on the day of transplantation.
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This study will be a single-center, open-label, randomized, proof of concept study in non-HLA-identical living donor renal transplants.
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 immunosuppressive withdrawal or continue therapy through study close. Sirolimus will first be weaned by halving the dose and/or increasing the dosing interval over a 3 month period.
After sirolimus is discontinued, participants will remain on belatacept alone for 3 additional months. Those still eligible for weaning by pre-defined criteria will then discontinue any further dosing of belatacept.
Follow-up will continue for at least five years. If subjects are successfully weaned from all immunosuppression during their participation in this trial, no other alternative therapy will be warranted. Pending FDA approval of belatacept during the five year course of the study, subjects would be eligible to continue this therapy. If belatacept has not been approved during the course of the study, the Principal Investigator will discuss approved treatment options with the study participants.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Allan D Kirk, M.D. | (404) 727-8380 | allan.kirk@emoryhealthcare.org |
Contact: Sue Mead, R.N. | (404) 712-1787 | sue.mead@emoryhealthcare.org |
United States, Georgia | |
Emory University Hospital | Recruiting |
Atlanta, Georgia, United States, 30322 | |
Principal Investigator: Allan D. Kirk, M.D. | |
The Emory Clinic | Recruiting |
Atlanta, Georgia, United States, 30322 |
Principal Investigator: | Allan D. Kirk, M.D. | Emory University |
Responsible Party: | Emory University ( Allan D. Kirk, M.D. ) |
Study ID Numbers: | BMS IM103-036 |
Study First Received: | November 28, 2007 |
Last Updated: | October 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00565773 |
Health Authority: | United States: Food and Drug Administration; United States: Institutional Review Board |
Abatacept Alemtuzumab |
Immunologic Factors Antineoplastic Agents Therapeutic Uses Physiological Effects of Drugs |
Antirheumatic Agents Immunosuppressive Agents Pharmacologic Actions |