Status:
COMPLETED
Safety Trial of Single Versus Multiple Dose Thymoglobulin Induction in Kidney Transplantation
Lead Sponsor:
Wright State University
Collaborating Sponsors:
Sanofi
University of Arizona
Conditions:
End-Stage Renal Disease
Kidney Failure
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
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 k...
Detailed Description
This study is designed to confirm the one-year safety of single-dose rabbit anti-thymocyte globulin induction at kidney transplantation, compared to the conventional administration of the same overall...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
99 Patients enrolled
Trial Details
Trial ID
NCT00906204
Start Date
March 1 2010
End Date
July 1 2014
Last Update
December 7 2015
Active Locations (4)
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1
University of Arizona
Tucson, Arizona, United States, 85724
2
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
3
Wake Forest University
Winston-Salem, North Carolina, United States, 27157
4
The Methodist Hospital Research Institute
Houston, Texas, United States, 77030