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

Information source: University of Nebraska
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: End-Stage Renal Disease; Kidney Failure; Kidney Transplantation

Intervention: Anti-thymocyte Globulin (rabbit) (rATG) (Thymoglobulin) (Drug); Divided-dose Thymoglobulin administration (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: University of Nebraska

Official(s) and/or principal investigator(s):
R.Brian Stevens, MD, PhD, Principal Investigator, Affiliation: University of Nebraska

Overall contact:
R. Brian Stevens, MD, PhD, Phone: 402-559-9072, Email: rbstevens@unmc.edu

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.

Clinical Details

Official title: Prospective, Randomized, Double-Blind, Double-Dummy, Multicenter Trial to Assess Safety of Single Dose vs. Traditional Administration of Thymoglobulin Induction for Renal Transplantation

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: Composite endpoint of 5 components: Fever, Hypoxia, Hypotension, Cardiac Events, and Delayed Graft Function

Secondary outcome:

Patient Survival

Graft survival

Acute rejection of transplanted kidney; biopsy-confirmed, clinically symptomatic

Incomplete Thymoglobulin infusion

Short-term kidney function (Immediately after transplantation)

Longer-term kidney function

Hematologic effects of Thymoglobulin administration (Effects of the 2 different dosing plans on white and red blood cells and platelets)

Immunologic effects of Thymoglobulin administration (studies of antibodies and specific immune cell types in the blood after transplantation)

Histopathology of kidney biopsies taken at transplantation and after 12 months

Detailed description: Two randomized groups of kidney transplant recipients will be each administered the drug Thymoglobulin according to a different dosing regimen. The control group will receive the usual and traditional regimen of a total of 6 mg/Kg divided into 4 doses, 1 on the day of transplantation and 1 each day on the next 3 days. The experimental group will receive the same total Thymoglobulin dose, 6 mg/Kg, but entirely on the day of transplantation.

The study will be double-blinded, with placebo doses of Thymoglobulin administered as needed to enrollees in the experimental group. Enrollment is targeted at 165, with 150 subjects needed to complete the study for adequate evaluation.

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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

<0. 35 with a flow rate of >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 <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.

Locations and Contacts

R. Brian Stevens, MD, PhD, Phone: 402-559-9072, Email: rbstevens@unmc.edu

University of Arizona, Tucson, Arizona 85724, United States; Not yet recruiting
Bruce Kaplan, MD, Phone: 520-626-6371, Email: bkaplan@deptofmed.arizona.edu

Scripps Health, La Jolla, California 92037, United States; Not yet recruiting
Christopher Marsh, MD, Phone: 858-554-4310, Email: marsh.christopher@scrippshealth.org

University of Maryland Medical System, Baltimore, Maryland 21201, United States; Not yet recruiting
Matthew Cooper, MD, Phone: 410-328-7336, Email: mcooper@smail.umaryland.edu

University of Nebraska Medical Center, Omaha, Nebraska 68198, United States; Recruiting
R. Brian Stevens, MD, PhD, Phone: 402-559-9072, Email: rbstevens@unmc.edu

Wake Forest University, Winston-Salem, North Carolina 27157, United States; Not yet recruiting
Alan C Farney, MD, PhD, Phone: 336-716-4241, Email: afarney@wfubmc.edu

Vanderbilt University, Nashville, Tennessee 37232, United States; Not yet recruiting
David Schaffer, MD, Phone: 615-936-0388, Email: david.shaffer@vanderbilt.edu

Additional Information

Related publications:

Stevens RB, Mercer DF, Grant WJ, Freifeld AG, Lane JT, Groggel GC, Rigley TH, Nielsen KJ, Henning ME, Skorupa JY, Skorupa AJ, Christensen KA, Sandoz JP, Kellogg AM, Langnas AN, Wrenshall LE. Randomized trial of single-dose versus divided-dose rabbit anti-thymocyte globulin induction in renal transplantation: an interim report. Transplantation. 2008 May 27;85(10):1391-9.

Starting date: March 2010
Last updated: April 16, 2010

Page last updated: February 07, 2013

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