TerminatedEarly Phase 1

Belatacept for Renal Transplant Recipients With Delayed Graft Function

Stopped: Drug unavailability due to a manufacturing transition.

United States8 participantsStarted 2014-04

Plain-language summary

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

Who can participate

Age range18 Years – 60 Years

SexALL

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Inclusion criteria

✓. Signed Written Informed Consent
✓. Deceased donor renal transplant recipient
✓. Men and women, aged 18-60 years of age

Exclusion criteria

✕. Seronegative or unknown EBV serostatus
✕. Patients unwilling or incapable of providing informed consent.
✕. Patients with active tuberculosis or positive TB test without evidence of infection treatment.
✕. 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
✕. Evidence of Sepsis or other clinical indicators deemed clinically contraindicated for study enrollment by the primary physician
✕. Inadequate vein access to receive monthly IV infusions
✕. Prior proven allergy or severe adverse drug reaction to mycophenolate, steroid or Belatacept preventing therapy.
✕. Pregnant women or women of child bearing age not willing to commit to dual contraception prophylaxis

What they're measuring

Time to recover from Delayed Graft Function

Timeframe: 2 weeks

Trial details

NCT IDNCT02134288

SponsorOhio State University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-12-11

View on ClinicalTrials.gov More Delayed Graft Function trials