CompletedPhase 4

Prospective Pilot Study of Pre-Transplant Thymoglobulin Administration in Living Donor Renal Transplant Recipients

United States11 participantsStarted 2008-09

Plain-language summary

To determine how safe and effective giving Thymoglobulin before transplantation to patients who are going to be receiving kidney transplants.

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Adult living donor renal transplant recipient.
✓. Patient is at least 18 years of age
✓. If female and of childbearing potential, have a negative serum or urine HCG within 24 hours prior to Study Day -5 (Day of 1st Thymoglobulin dose) and must practice a medically approved method of birth control for the past 30 days prior to enrollment and agree to continue this practice during the 6 month efficacy analysis.
✓. Signed informed consent.

✕. Human Leukocyte Antibody (HLA) identical living donor transplant recipient.
✕. History of a positive cross-match with the donor.
✕. Patients with a peak CDC PRA \> 50% or a current CDC PRA \> 25%.
✕. Patients who have previously received a kidney transplant.
✕. Active donor or recipient serology positive for human immunodeficiency virus (HIV), Hepatitis B virus (HBV), or Hepatitis C virus (HCV).
✕. History of noncompliance.
✕. History of chronic corticosteroid or immunosuppressive use except for inhaled corticosteroids to treat asthma. .
✕. Multiple organ transplant recipient.

Composite End Point of Acute Rejection, Graft Loss or Patient Death

Timeframe: 6 months

NCT IDNCT00771745

SponsorUniversity of Cincinnati

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2010-06

Results submitted2013-01-18