Efficacy of Belatacept in Reducing DSA

NCT02078193 | Completed Phase 4 Results

• 1 other identifier: IM103-302
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Kidney Transplantation

Outcome Measures

Primary Outcomes (1)

• Change of Donor Specific Antibodies (DSA)

  DSA levels will be measured using microbeads coated with Class I or Class II human leukocyte antigens (HLA) and read using a Luminex flow cytometer. Participants will be converted from their current Mycophenolate Mofetil (MMF) to once a month infusions of Belatacept.

  one year

Secondary Outcomes (1)

• Safety

  one year

Other Outcomes (1)

• Number of Participants With Chronic Kidney Rejection

  One year

Study Arms (1)

Belatacept

EXPERIMENTAL

Participants will be converted from their current MMF to once a month infusions of Belatacept

Drug: Belatacept

Interventions

Belatacept DRUG

Patients will be converted from their MMF to Belatacept

Belatacept

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 serum creatinine (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 mycophenolic acid (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.

You may not qualify if:

• 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 Epstein-Barr virus (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. Aspartate Aminotransferase (AST), Alanine Aminotransferase (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;
• 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 human chorionic gonadotropin (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.

Sponsors & Collaborators

• East Carolina University: lead

Study Sites (1)

East Carolina University

Greenville, North Carolina, 27834, United States

Location

MeSH Terms

Interventions

Abatacept

Intervention Hierarchy (Ancestors)

Immunoconjugates; Antibodies; Immunoglobulins; Serum Globulins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Globulins

Results Point of Contact

• Title: Austin Rice
• Organization: East Carolina University, Division of Nephrology

riceau15@ecu.edu

252-744-1904

Study Officials

• Paul Bolin, MD

  East Carolina University, Department Chair of Internal Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Paul Bolin, MD

Study Record Dates

• First Submitted: March 3, 2014
• First Posted: March 5, 2014
• Study Start: November 1, 2013
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: August 1, 2017
• Results First Posted: July 6, 2017

Record last verified: 2017-07

Locations

US (1)