Phase 2
Completed N=97
Safety Trial of Single Versus Multiple Dose Thymoglobulin Induction in Kidney Transplantation
Source: ClinicalTrials.gov NCT00906204 ↗Enrolled (actual)
97
Serious AEs
46.3%
Results posted
Dec 2015
Primary outcomePrimary: Composite Endpoint of 5 Components: Fever, Hypoxia, Hypotension, Cardiac Events, and Delayed Graft Function — 13; 12 participants — p=0.64
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 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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Composite Endpoint of 5 Components: Fever, Hypoxia, Hypotension, Cardiac Events, and Delayed Graft Function |
13; 12 | 0.64 |
| SECONDARY Patient Survival |
44; 50 | 0.35 |
| SECONDARY Graft Survival |
42; 50 | 0.47 |
| SECONDARY Acute Kidney Rejection |
5; 5 | 0.78 |
| SECONDARY Incomplete Thymoglobulin Infusion |
3; 5 | 0.72 |
| SECONDARY Kidney Function |
59.3; 61.3 | 0.85 |
Eligibility Criteria
Inclusion Criteria
- 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 60 ml/min.
Exclusion Criteria
- 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 37 should be considered on an individual basis based on overall health and body habitus.
Data sourced from ClinicalTrials.gov (NCT00906204). 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. Informational only — not medical advice.