Phase 4
N=11
Prospective Pilot Study of Pre-Transplant Thymoglobulin Administration in Living Donor Renal Transplant Recipients
Renal Transplant Rejection · Transplants and Implants
Bottom Line
View on ClinicalTrials.gov: NCT00771745 ↗Enrolled (actual)
11
Serious AEs
45.5%
Results posted
Nov 2015
Primary outcome: Primary: Composite End Point of Acute Rejection, Graft Loss or Patient Death — 1; 1; 0; 0 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Thymoglobulin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Cincinnati
- Primary completion
- Jun 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Composite End Point of Acute Rejection, Graft Loss or Patient Death |
1; 1; 0; 0; 0; 0 | — |
| SECONDARY Incidence of Treatment Failures: Defined as the Percentage of Patients That do Not Remain on Initial Therapy. |
— | — |
| SECONDARY Incidence of Infections |
— | — |
| SECONDARY Need for Antilymphocyte Antibody Therapy to Treat Acute Rejection |
— | — |
| SECONDARY Severity of Biopsy-proven Rejection Using Banff 97 Criteria |
— | — |
| SECONDARY Serum Creatinine |
— | — |
| SECONDARY Malignancy |
— | — |
Summary
To determine how safe and effective giving Thymoglobulin before transplantation to patients who are going to be receiving kidney transplants.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
- Patient with a urinary bladder that is absent or not functional (e.g. self catheterization) pretransplant.
- Patient who does not agree to use effective birth control during the 6-month efficacy analysis.
- Known contraindication to administration of rabbit antithymocyte globulin.
- Initial screening laboratory evaluations will be done locally before renal transplantation and the following laboratory values will be exclusionary: Platelets < 100,000/mm23 or WBC < 3000/mm3
- Currently abusing drugs or alcohol or, in the opinion of the investigator, is at high risk for poor compliance.
- Patient who, in the opinion of the investigator, has significant medical or psychosocial problems or unstable disease states that would preclude participation in the study. Examples of significant problems include, but are not limited to, morbid obesity or severe cardiac disease.
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Data sourced from ClinicalTrials.gov (NCT00771745). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.