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Belatacept Therapy for the Failing Renal Allograft

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

Condition(s) targeted: Renal Transplant

Intervention: belatacept (Nulojix) (Drug); Calcineurin inhibitor therapy (Drug); mycophenolate mofetil (Drug); prednisone (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Andrew B Adams, MD, PhD

Official(s) and/or principal investigator(s):
Andrew B Adams, MD, PhD, Principal Investigator, Affiliation: Emory University

Overall contact:
Andrew B Adams, MD, PhD, Phone: 404-712-8424, Email: andrew.b.adams@emory.edu

Summary

The purpose of this study is to test the safety and effectiveness of belatacept (Nulojix®) in preventing antibody formation in patients with chronic failing kidney transplants. This study is a randomized study of first-time kidney transplant patients who have worsening kidney function and biopsy proven grade 2 or 3 interstitial fibrosis/tubular atrophy (IF/TA). Patients must be eligible to get a second transplant. They must have completed or be actively undergoing evaluation for re-listing for a second transplant. Patients will be randomized to either convert to belatacept or continue on calcineurin inhibitor-based therapy.

Clinical Details

Official title: Belatacept Therapy for the Failing Renal Allograft

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

Primary outcome: Development of donor-specific antibody

Secondary outcome: preservation of glomerular filtration rate

Eligibility

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Signed Written Informed Consent

- Kidney transplant recipient (non-HLA identical donor) who now has impaired renal

allograft function with:

- Estimated GFR < 35 with a decline in GFR of > 10% in the 12 months prior to

enrollment and must have biopsy proven grade II or III interstitial fibrosis/tubular atrophy (IF/TA) OR

- Estimated GFR persistently < 20 ml/min over the 6 month period prior to enrollment

absent other causes for graft dysfunction, and deemed to have a failing allograft by the patient's transplant nephrologist

- On a maintenance immunosuppressive regimen that includes calcineurin inhibitor

(CNI)(tacrolimus or cyclosporine) or sirolimus and at least

- MMF of a dose of at least 1 gm/day or comparable dose of azathioprine OR

- Prednisone at a dose of at least 5 mg/day

- Men and women, ages 18 to 70, inclusive

Exclusion Criteria:

- WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for

the entire study period and for up to 8 weeks after the last dose of study drug.

- Women who are pregnant or breastfeeding.

- Women with a positive pregnancy test.

- Sexually active fertile men not using effective birth control if their partners are

WOCBP.

- Subjects who are Epstein-Barr Virus (EBV) seronegative.

- Subjects with any prior solid organ (e. g., heart, liver, pancreas) or cell (e. g.,

islet, bone marrow) transplant other than a renal allograft. Exception may be made for recipient of a simultaneous kidney-pancreas transplant who had previously experienced graft loss of the pancreas allograft due to thrombosis or rejection.

- Subjects with presence of donor specific antibody at the time of enrollment

- Subjects who have a recent history (within 1 yr) of biopsy proven acute rejection >

Banff grade Ia

- Subjects who have a living donor identified for re-transplant within 3 months

- Subjects with a history of post-transplant lymphoproliferative disease (PTLD)

- Subjects at risk for tuberculosis (TB)

- Subjects with a history of cancer within the past 3 years, other than non-melanoma

skin cancer(s)

- Subjects with a positive BK serum PCR > 20,000 copies at the time of enrollment OR

history of biopsy-proven BK nephropathy within the year prior to enrollment.

- Subjects with a mammogram that is suspicious for malignancy and in whom the

possibility of malignancy cannot be reasonably excluded following additional clinical, laboratory, or other diagnostic evaluations

- Subjects who have difficult intravenous access or other reasons that would likely

preclude the ability to receive long-term intravenous infusions

- Hypersensitivity to any medications that will be used in the protocol

- Subjects who have used any investigational drug within the 30 days prior to

anticipated enrollment

- Subjects currently receiving belatacept as part of their maintenance

immunosuppressive regimen

- Prisoners, or subjects who are involuntarily incarcerated.

- Subjects who are compulsorily detained for treatment of either a psychiatric or

physical (eg, infectious disease) illness.

Locations and Contacts

Andrew B Adams, MD, PhD, Phone: 404-712-8424, Email: andrew.b.adams@emory.edu

Emory University, Atlanta, Georgia 30322, United States; Recruiting
Andrew B Adams, MD, PhD, Phone: 404-712-8424, Email: andrew.b.adams@emory.edu
Jennifer Brosseau, RN, Phone: 404-712-1161, Email: jennifer.lynn.brosseau@emoryhealthcare.org
Andrew B. Adams, MD, PhD, Principal Investigator
Additional Information

Starting date: August 2013
Last updated: April 25, 2015

Page last updated: August 23, 2015

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