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Belatacept Post Depletional Repopulation to Facilitate Tolerance

Information source: Emory University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Organ Transplantation

Intervention: Belatacept (Drug); Belatacept (Drug); Alemtuzumab (Drug); donor bone marrow (Other)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: Emory University

Official(s) and/or principal investigator(s):
Antonio Guasch, MD, Principal Investigator, Affiliation: Emory University

Summary

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 the recently FDA approved 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 oral anti-rejection medications over time. 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 now FDA approved and is being studied in transplant patients. Sirolimus (Rapamune) is approved for use in transplant patients, but its use with belatacept and alemtuzumab is investigational. In the initial 20 subjects enrolled in the study, half tested whether an infusion of bone marrow from the kidney donor would improve the effect of these drugs. This bone marrow infusion was also considered investigational. Enrollment of 20 additional subjects was begun in January, 2013. The donor bone marrow infusion has been eliminated. Enrollment was open to primary living and deceased donor kidney recipients. Enrollment is closed as of 8/12/2014.

Funding Source - FDA OOPD

Clinical Details

Official title: Use of Belatacept During Post Depletional Repopulation to Facilitate Tolerance in Renal Allograft Recipients

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: 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.

Secondary outcome: Assessment of proposed therapies to prevent acute and/or chronic rejection by 1,3, and 5 years compared to the standard reported in the UNOS database for patients with similar demographics.

Detailed description: 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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Emory University Hospital, Atlanta, Georgia 30322, United States

The Emory Clinic, Atlanta, Georgia 30322, United States

Additional Information

Starting date: December 2007
Last updated: November 25, 2014

Page last updated: August 23, 2015

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