NCT01280617

Brief Summary

This is a planned single center prospective randomized study evaluating the safety and efficacy of low dose thymoglobulin as induction agent in renal transplant recipients. Inclusion criteria will be adult renal transplant recipients who are not sensitized against their potential donors. The patients who agree to participate in the study will be randomly assigned to either thymoglobulin at 1.25mg/kg x 3 doses or 0.75mg/kg x 3 doses. There will be 86 sealed envelopes to perform the randomization process. 43 envelopes with 1.25mg/kg dosing and the other 43 envelopes with 0.75mg/kg dosing. The investigators will sequentially choose the sealed envelopes at the time of the patient randomization process. All patients will be started on our standard immunosupression regimen of prograf/cellcept and a fast steroid taper. Data will be obtained from every patient for up to one year post-transplant.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 19, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 21, 2011

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
7.2 years until next milestone

Results Posted

Study results publicly available

March 16, 2021

Completed
Last Updated

March 16, 2021

Status Verified

February 1, 2021

Enrollment Period

3.1 years

First QC Date

January 19, 2011

Results QC Date

September 11, 2020

Last Update Submit

February 23, 2021

Conditions

Acute Renal Failure

Keywords

Renal TransplantThymoglubulin

Outcome Measures

Primary Outcomes (1)

  • Rates of Acute Cellular Rejection Between Study Group

    Incidence of Biopsy Proven Acute Rejection at 1 year post transplant:

    1 year from date of transplant

Secondary Outcomes (1)

  • , "Total Number of Adverse Events, Including Any Infections, Leucopenia, and Malignancy"

    1 year from date of transplant

Study Arms (2)

Thymoglobulin 1.25mg/kg dose

EXPERIMENTAL

The safety and efficacy of low dose Thymoglobulin (1.25mg/kg) as an induction agent in renal transplant subjects.

Drug: Thymoglobulin

Thymoglobulin 0.75mg/kg dose

EXPERIMENTAL

The safety and efficacy of low dose Thymoglobulin (0.75mg/kg) as an induction agent in renal transplant subjects.

Drug: Thymoglobulin 0.75mg/kg dose

Interventions

ThymoglobulinDRUG

Thymoglobulin 1.25mg/kg dose

Thymoglobulin 1.25mg/kg dose
Thymoglobulin 0.75mg/kg doseDRUG

Thymoglobulin

Also known as: Thymoglobulin
Thymoglobulin 0.75mg/kg dose

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Potential Adult Renal Transplant Patients -

You may not qualify if:

  • Sensitized Renal Transplant Patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lahey Clinic

Burlington, Massachusetts, 01805, United States

Location

Related Publications (1)

  • Grafals M, Smith B, Murakami N, Trabucco A, Hamill K, Marangos E, Gilligan H, Pomfret EA, Pomposelli JJ, Simpson MA, Azzi J, Najafian N, Riella LV. Immunophenotyping and efficacy of low dose ATG in non-sensitized kidney recipients undergoing early steroid withdrawal: a randomized pilot study. PLoS One. 2014 Aug 11;9(8):e104408. doi: 10.1371/journal.pone.0104408. eCollection 2014.

    PMID: 25111080RESULT

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

thymoglobulin

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Results Point of Contact

Title
Mary Ann Simpson, Ph.D
Organization
Lahey Hospital & Medical Ctr
Mary.a.Simpson@Lahey.org
781-744-2500

Study Officials

  • Simpson

    Lahey Hospital & Medical Ctr

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 19, 2011

First Posted

January 21, 2011

Study Start

October 1, 2010

Primary Completion

November 1, 2013

Study Completion

January 1, 2014

Last Updated

March 16, 2021

Results First Posted

March 16, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)