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Belatacept for Renal Transplant Recipients With Delayed Graft Function

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

Condition(s) targeted: Delayed Graft Function

Intervention: Belatacept (Drug); Everolimus (Drug)

Phase: Phase 0

Status: Recruiting

Sponsored by: Von Visger, Jon, MD

Official(s) and/or principal investigator(s):
Jon Von Visger, M.D./Ph.D., Principal Investigator, Affiliation: OSU Wexner Medical Center

Overall contact:
Jerry Phalan, Phone: 614-293-4665, Email: jerry.phalan@osumc.edu

Summary

Currently looking for individuals that have received a kidney transplant, are experiencing delayed graft function (DGF), and meet the criteria for study participation.

Clinical Details

Official title: Prospective, Randomized Trial of Belatacept Switch in Renal Transplant Recipients With Delayed Graft Function

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

Primary outcome: Time to recover from Delayed Graft Function

Secondary outcome:

Percent patients reaching recovery (defined above) by 14 days and 3 months.

Hospital length of stay (days) from date of transplant to discharge

Number of dialysis treatments

Number of biopsies

Biopsy proven acute rejection events

Patient and graft survival

Number of hospital readmissions

Detection of DSA (Luminex)

Incidence and type of infection

Measured or estimated creatinine clearance.

Banff score of rejection episodes and immune suppression treatment/management of rejection

Immune suppression drug levels (everolimus or sirolimus, cyclosporine, or mycophenolate as clinically monitored).

Detailed description: Patients who undergo kidney transplantation require long term immunosuppressive therapy (therapy that reduces your body's ability to respond to anything foreign) to prevent damage to the graft, and some experience delayed graft function (DGF, a condition in which the transplanted kidney does not function properly) after transplantation. This study is being conducted to determine if kidney transplant recipients with delayed graft function (DGF) who are switched to the immunosuppressive regimen of belatacept with mycophenolate and steroid will recover from delayed graft function (DGF) in less time (which could potentially lower the risk of rejection associated with delayed graft function) than kidney transplant recipients with delayed graft function (DGF) who remain on the current standard immunosuppressive regimen (standard of care).

Eligibility

Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Signed Written Informed Consent 2. Deceased donor renal transplant recipient 3. Men and women, aged 18-60 years of age Exclusion Criteria: 1. Seronegative or unknown EBV serostatus 2. Patients unwilling or incapable of providing informed consent. 3. Patients with active tuberculosis or positive TB test without evidence of infection treatment. 4. Patients with demonstrated acute rejection on first biopsy evaluation for delayed graft function; Second transplant or multiple organ transplant; patients more than 12 days post renal transplant prior to enrollment 5. Evidence of Sepsis or other clinical indicators deemed clinically contraindicated for study enrollment by the primary physician 6. Inadequate vein access to receive monthly IV infusions 7. Prior proven allergy or severe adverse drug reaction to mycophenolate, steroid or Belatacept preventing therapy. 8. Pregnant women or women of child bearing age not willing to commit to dual contraception prophylaxis 9. Use of alemtuzumab (Campath 1-H©), basilixumab (Simulect©) and daclizumab (Zenapax©) are not permitted in this protocol; Use of other immunosuppressive agents must be limited to those specified in this protocol. 10. Prisoners or subjects who are involuntarily incarcerated. 11. Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness. 12. Pre-sensitized patients with alloscreen antibody levels of 80% or more class I or class II

Locations and Contacts

Jerry Phalan, Phone: 614-293-4665, Email: jerry.phalan@osumc.edu

The Ohio State Universtiy Wexner Medical Center, Columbus, Ohio 43212, United States; Recruiting
Jerry Phalan, Phone: 614-293-4665, Email: jerry.phalan@osumc.edu
Jon Von Visger, M.D./Ph.D., Principal Investigator
Additional Information

Starting date: April 2014
Last updated: May 7, 2014

Page last updated: August 23, 2015

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