Safety Trial of Single Versus Multiple Dose Thymoglobulin Induction in Kidney Transplantation

Completed · Phase 2

Conditions studied: End-Stage Renal Disease, Kidney Failure

In brief

In a non-blinded pilot study conducted at the University of Nebraska Medical Center, evidence was found that a single large dose of Thymoglobulin on the day of kidney transplantation produced better kidney function than the standard dosing plan, when the same amount is divided into smaller doses on 4 days. This new study repeats that dose comparison, but with double-blinding and at multiple transplantation centers.

Key facts

Study ID

NCT00906204

Run by

Wright State University

People needed

99

Starts

2010-03-01

Expected to finish

2014-07-01

Last updated by the study team

2015-12-07

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject capable of giving written informed consent, with end-stage kidney disease, who is a suitable candidate for primary kidney transplantation
• Male or female subject who has reached legal age in the state where they reside and is at least 18 years of age
• Deceased or living donors
• Compatible ABO blood type
• Expanded-criteria donor (ECD) kidneys with a donor grade score of ≤ 25 (as developed by Nyberg, et al.)
• If Kidneys are pumped, they must meet the following pumping parameters: resistance <0.35 with a flow rate of >60 ml/min.

You may not qualify if…

• Recipient age >65 years
• PRA >50%, or donor-specific antibody
• CIT >30 hours
• Re-transplant patients
• Multi-organ transplant recipients (example: kidney/pancreas or kidney/liver)
• Renal transplant recipients planned for future pancreas transplantation
• Current unstable cardiovascular disease or history of myocardial infarction within the previous 6 months
• Current malignancy or history or malignancy (within the previous 5 years) with the exception of non-metastatic basal or squamous cell carcinoma of the skin or carcinoma in-situ of the cervix that has been treated successfully.
• Hepatitis B and C recipients or active liver disease
• HIV positive recipients
• Primary disease requiring treatment with steroids after transplantation
• Expanded-criteria donor kidneys (current UNOS criteria) with a donor grade score of > 25
• Donation after cardiac death (DCD) donors
• Dual adult kidneys
• Recipients of pediatric (age <12 years) unilateral or en-bloc kidneys
• Previous treatment with rATG
• Known hypersensitivity, extensive exposure, or allergy to rabbits
• Pregnant
• Any condition that in the investigator's opinion may compromise study participation (e.g., history or likelihood of non-compliance with immunosuppression regimen, protocol visits, tests, and studies)
• Relative Exclusion Criteria:
• Patients with a BMI > 37 should be considered on an individual basis based on overall health and body habitus.

Where it is running

• University of Arizona — Tucson, Arizona, United States
• University of Nebraska Medical Center — Omaha, Nebraska, United States
• Wake Forest University — Winston-Salem, North Carolina, United States
• The Methodist Hospital Research Institute — Houston, Texas, United States

Full record on ClinicalTrials.gov

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