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Efficacy of Belatacept in Reducing DSA

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

Condition(s) targeted: Kidney Transplantation

Intervention: Belatacept (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: East Carolina University

Official(s) and/or principal investigator(s):
Paul Bolin, MD, Principal Investigator, Affiliation: East Carolina University, Department Chair of Internal Medicine

Overall contact:
Winifred Bryant, Phone: 252-744-2577, Email: bryantw@ecu.edu

Summary

The primary objective of this study is to demonstrate that administration of belatacept in maintenance kidney transplant recipients may cause a reduction in Donor Specific HLA Antibody (DSA).

Clinical Details

Official title: An Exploratory, Open-label, Single Center Study to Assess the Efficacy of NULOJIX (Belatacept) in Reducing Donor Specific HLA Antibody (DSA) Strength in Maintenance Kidney Transplant Recipients

Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Reduction of Donor Specific Antibodies (DSA)

Secondary outcome: Assessing Safety

Detailed description: The aim of this study is to evaluate patients converted to belatacept in combination with MMF with corticosteroids with respect to their DSA titer. Patients in this study will be converted from their CNI to belatacept from baseline in an attempt to down-modulate antibody production by B-cells. Dosing will be calculated per prescribing information for dosing maintenance phase (5mg per kg every 28 days.

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Recipients of cadaveric, living related or living unrelated kidney transplant with

positive DSA titer (two positive tests) and enrolled within 6 months of DSA detection.

- Patients with stable renal function. Stable renal function is defined as one SCr

value that is +/- 10% of the baseline SCR within 3 months of enrollment (eGFR >/= 35 and - Patients who are EBV seropositive

- Males and females, 18-75 years of age;

- Patients currently receiving MPA (CellCept daily or myfortic daily), cyclosporine or

tacrolimus with corticosteroids as part of their immunosuppressive regimen

- Patients willing to be converted to belatacept from cyclosporine or tacrolimus.

- Females of childbearing potential must have a negative pregnancy test prior to

enrollment. The test should be performed at baseline visit. Effective contraception must be used during the trial, and for 4 weeks following discontinuation of the study medication;

- Patients who are willing and able to participate in the full course of the study and

from whom written informed consent has been obtained. Exclusion Criteria:

- Multi-solid or cellular organ transplants (e. g. combined with pancreas, liver, islet,

bone marrow), either concurrent or previous (with exception that a second kidney transplant is allowed);

- Evidence of graft rejection or treatment of acute rejection within 14 days prior to

Baseline visit;

- Patients who have received any investigational drug within 4 weeks prior to study

entry;

- Patients with HLA identical

- Patients who are EBV seronegative

- Presence of clinically significant infection requiring continued therapy, chronic

infection (e. g. HIV, Hep B and Hep C), malignancy (within last 5 years, except excised squamous or basal cell carcinoma of the skin), lymphoma or renal toxicity that would interfere with the appropriate conduct of the study;

- Evidence of severe liver disease (incl. abnormal liver profile i. e. AST, ALT or total

bilirubin >/= 3 times ULN) or severe diarrhea or active peptic ulcer disease that would interfere with the appropriate conduct of the study;

- Abnormal physical or laboratory findings of clinical significance within 2 weeks of

inclusion which would interfere with the objectives of the study;

- Patients with symptoms of significant somatic or mental illness or evidence of drug

and/or alcohol abuse;

- Patients receiving > 10 mg/day prednisone dose;

- History of hypersensitivity to any of the study drugs or to drugs with similar

chemical structures to belatacept;

- Patients not making DSA antibodies;

- Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a

female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (local); females of childbearing potential who are unwilling to use effective study-approved contraceptives and who are planning to become pregnant; Sexually active fertile men must use effective birth control if their partners are women of child bearing potential;

- Any other medical condition that, in the opinion of the site investigator based on

recall or chart review would interfere with completing the study, including but not limited to visual problems or cognitive impairment.

Locations and Contacts

Winifred Bryant, Phone: 252-744-2577, Email: bryantw@ecu.edu

East Carolina University, Greenville, North Carolina 27834, United States; Recruiting
Winifred Bryant, Phone: 252-744-2577, Email: bryantw@ecu.edu
Paul Bolin, MD, Principal Investigator
Robert Harland, MD, Sub-Investigator
Additional Information

Starting date: November 2013
Last updated: February 13, 2015

Page last updated: August 23, 2015

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