MedDataX Logo

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

NCT ID: NCT00906204

Last Updated: 2015-12-07

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

99 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2014-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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 dose divided into four smaller doses across four days. 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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

End-Stage Renal Disease Kidney Failure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Single-dose Thymoglobulin

Biological/Vaccine Single-dose rabbit Anti-thymocyte Globulin induction, 6 mg/kg IV infusion

Group Type EXPERIMENTAL

Single-dose rabbit Anti-thymocyte Globulin induction

Intervention Type BIOLOGICAL

6 mg of rATG administered in a single dose on the day of kidney transplantation

Divided-dose Thymoglobulin

Biological/Vaccine Divided-dose rabbit Anti-thymocyte Globulin induction, 1.5 mg/kg IV infusion QD x 4

Group Type ACTIVE_COMPARATOR

Divided-dose rabbit Anti-thymocyte Globulin induction

Intervention Type BIOLOGICAL

6 mg/kg total rabbit Anti-thymocyte Globulin dose administered as 1.5 mg/kg doses on 4 sequential days, beginning on the day of kidney transplantation.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Single-dose rabbit Anti-thymocyte Globulin induction

6 mg of rATG administered in a single dose on the day of kidney transplantation

Intervention Type BIOLOGICAL

Divided-dose rabbit Anti-thymocyte Globulin induction

6 mg/kg total rabbit Anti-thymocyte Globulin dose administered as 1.5 mg/kg doses on 4 sequential days, beginning on the day of kidney transplantation.

Intervention Type BIOLOGICAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Thymoglobulin rATG Thymoglobulin rATG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)


* Patients with a BMI \> 37 should be considered on an individual basis based on overall health and body habitus.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Sanofi

INDUSTRY

Sponsor Role collaborator

University of Arizona

OTHER

Sponsor Role collaborator

Wake Forest University

OTHER

Sponsor Role collaborator

University of Nebraska

OTHER

Sponsor Role collaborator

The Methodist Hospital Research Institute

OTHER

Sponsor Role collaborator

Wright State University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

R. Brian Stevens, MD, PhD, FACS, FAST

Professor of Surgery and Graduate Studies and Director, Transplantation Division

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

R.Brian Stevens, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Wright State University, Dayton, Ohio

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Arizona

Tucson, Arizona, United States

Site Status

University of Nebraska Medical Center

Omaha, Nebraska, United States

Site Status

Wake Forest University

Winston-Salem, North Carolina, United States

Site Status

The Methodist Hospital Research Institute

Houston, Texas, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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. doi: 10.1097/TP.0b013e3181722fad.

Reference Type BACKGROUND
PMID: 18497677 (View on PubMed)

Stevens RB, Foster KW, Miles CD, Lane JT, Kalil AC, Florescu DF, Sandoz JP, Rigley TH, Nielsen KJ, Skorupa JY, Kellogg AM, Malik T, Wrenshall LE. A randomized 2x2 factorial trial, part 1: single-dose rabbit antithymocyte globulin induction may improve renal transplantation outcomes. Transplantation. 2015 Jan;99(1):197-209. doi: 10.1097/TP.0000000000000250.

Reference Type BACKGROUND
PMID: 25083614 (View on PubMed)

Stevens RB, Wrenshall LE, Miles CD, Farney AC, Jie T, Sandoz JP, Rigley TH, Osama Gaber A. A Double-Blind, Double-Dummy, Flexible-Design Randomized Multicenter Trial: Early Safety of Single- Versus Divided-Dose Rabbit Anti-Thymocyte Globulin Induction in Renal Transplantation. Am J Transplant. 2016 Jun;16(6):1858-67. doi: 10.1111/ajt.13659. Epub 2016 Mar 7.

Reference Type DERIVED
PMID: 26696251 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

183-09-FB

Identifier Type: -

Identifier Source: org_study_id