Prospective Pilot Study of Pre-Transplant Thymoglobulin Administration in Living Donor Renal Transplant Recipients - Full Text View

Sponsors and Collaborators:	University of Cincinnati Genzyme
Information provided by:	University of Cincinnati
ClinicalTrials.gov Identifier:	NCT00771745

Purpose

To determine how safe and effective giving Thymoglobulin before transplantation to patients who are going to be receiving kidney transplants.

Condition	Intervention	Phase
Organ Transplantation Transplantation Immunology	Drug: anti-thymocyte globulin (rabbit)	Phase IV

MedlinePlus related topics: Kidney Transplantation

Drug Information available for: Tacrolimus Mycophenolate Mofetil Mycophenolate mofetil hydrochloride Corticosteroids Tacrolimus anhydrous

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	Prospective, Single Center, Pilot Study of Pretransplant Thymoglobulin Administration and Early Corticosteroid Withdrawal in Living Donor Renal Transplant Recipients Under Mycophenolate Mofetil (MMF) and Tacrolimus Maintenence Immunosuppression

Further study details as provided by University of Cincinnati:

Primary Outcome Measures:

Composite end point of acute rejection, graft survival or patient survival [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Incidence of treatment failures: defined as the percentage of patients that do not remain on initial therapy. [ Time Frame: Ongoing ] [ Designated as safety issue: No ]
Incidence of infections [ Time Frame: Not defined ] [ Designated as safety issue: No ]
Need for antilymphocyte antibody therapy to treat acute rejection [ Time Frame: Not defined ] [ Designated as safety issue: No ]
Severity of biopsy-proven rejection using Banff 97 Criteria [ Time Frame: Not defined ] [ Designated as safety issue: No ]
Delayed Graft Function [ Time Frame: Undefined ] [ Designated as safety issue: No ]
Serum creatinine [ Time Frame: Post-operative days 1-7, 1, 3 and 6 months ] [ Designated as safety issue: No ]
Malignancy [ Time Frame: Undefined ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	20
Study Start Date:	September 2008
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Preloading Induction with Thymoglobulin® X 4 doses given day -4, day -2, day 0, and day 2 at 1.5 mg/kg/dose + corticosteroid taper + tacrolimus + MMF	Drug: anti-thymocyte globulin (rabbit) Preloading Induction with Thymoglobulin® X 4 doses given day -4, day -2, day 0, and day 2 at 1.5 mg/kg/dose + corticosteroid taper + tacrolimus + MMF
2: Active Comparator Preloading Induction with Thymoglobulin® X 3 doses given day -4 (1.5mg/kg), day -2 (1.5mg/kg), and day 0 (3mg/kg) + corticosteroid taper + tacrolimus + MMF	Drug: anti-thymocyte globulin (rabbit) Preloading Induction with Thymoglobulin® X 3 doses given day -4 (1.5mg/kg), day -2 (1.5mg/kg), and day 0 (3mg/kg) + corticosteroid taper + tacrolimus + MMF

Detailed Description:

We will evaluate the therapeutic efficacy of administering Thymoglobulin® induction pre-transplantation in renal allograft recipients. Patients receiving pre-transplant Thymoglobulin will be evaluated for acute rejection (Banff '97 criteria), survival, and safety at 6 months. Overall the use of Thymoglobulin induction pre-transplantation will be safe and effective.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Adult living donor renal transplant recipient.
Patient is at least 18 years of age
If female and of childbearing potential, have a negative serum or urine HCG within 24 hours prior to Study Day -5 (Day of 1st Thymoglobulin dose) and must practice a medically approved method of birth control for the past 30 days prior to enrollment and agree to continue this practice during the 6 month efficacy analysis.
Signed informed consent.

Exclusion Criteria:

Human Leukocyte Antibody (HLA) identical living donor transplant recipient.
History of a positive cross-match with the donor.
Patients with a peak CDC PRA > 50% or a current CDC PRA > 25%.
Patients who have previously received a kidney transplant.
Active donor or recipient serology positive for human immunodeficiency virus (HIV), Hepatitis B virus (HBV), or Hepatitis C virus (HCV).
History of noncompliance.
History of chronic corticosteroid or immunosuppressive use except for inhaled corticosteroids to treat asthma. .
Multiple organ transplant recipient.
Patient with a urinary bladder that is absent or not functional (e.g. self catheterization) pretransplant.
Patient who does not agree to use effective birth control during the 6-month efficacy analysis.
Known contraindication to administration of rabbit antithymocyte globulin.
Initial screening laboratory evaluations will be done locally before renal transplantation and the following laboratory values will be exclusionary: Platelets < 100,000/mm23 or WBC < 3000/mm3
Currently abusing drugs or alcohol or, in the opinion of the investigator, is at high risk for poor compliance.
Patient who, in the opinion of the investigator, has significant medical or psychosocial problems or unstable disease states that would preclude participation in the study. Examples of significant problems include, but are not limited to, morbid obesity or severe cardiac disease.

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Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00771745

Locations

United States, Ohio
The Christ Hospital	Recruiting
Cincinnati, Ohio, United States, 45219
Contact: Adele Rike, PharmD 513-585-2145
Principal Investigator: Adele Rike, PharmD
Principal Investigator: E. Steve Woodle, MD

Sponsors and Collaborators

University of Cincinnati

Genzyme

Investigators

Principal Investigator:	E. Steve Woodle, MD	University of Cincinnati
Principal Investigator:	Adele Rike, PharmD	The Christ Hospital

More Information

Responsible Party:	University of Cincinnati ( E. Steve Woodle, MD, FACS )
Study ID Numbers:	Pre-Tx Thymo
Study First Received:	October 10, 2008
Last Updated:	October 10, 2008
ClinicalTrials.gov Identifier:	NCT00771745
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Antilymphocyte Serum
Mycophenolate mofetil
Tacrolimus

Additional relevant MeSH terms:

Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009