Efficacy of Belatacept in Reducing DSA

Kidney Transplantation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02078193
• Other study ID #: IM103-302
• Status: Completed
• Phase: Phase 4
• First received: March 3, 2014
• Last updated: August 1, 2016
• Start date: November 2013
• Est. completion date: July 2016

Study information

• Verified date: August 2016
• Source: East Carolina University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 </= 75 mL/min/1.73m^2).

• 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.

Study Design

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

Related Conditions & MeSH terms

• Kidney Transplantation

Intervention

Drug:
• Belatacept
Patients will be converted from their MMF to Belatacept

Locations

Country	Name	City	State
United States	East Carolina University	Greenville	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
East Carolina University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Assess chronic kidney rejection	assess incidence of chronic kidney rejection	one year	No
Primary	Reduction of Donor Specific Antibodies (DSA)	Will assess if the use of Belatacept reduces DSA	one year	No
Secondary	Assessing Safety	assess overall safety, including incidence of infections	one year	Yes