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

Renal Transplant Rejection Clinical Trial

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 Immunosuppression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00771745
• Other study ID #: Pre-Tx Thymo
• Status: Completed
• Phase: Phase 4
• First received: October 10, 2008
• Last updated: December 15, 2015
• Start date: September 2008
• Est. completion date: July 2010

Study information

• Verified date: December 2015
• Source: University of Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: July 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Adult living donor renal transplant recipient.

2. Patient is at least 18 years of age

3. 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.

4. Signed informed consent.

Exclusion Criteria:

1. Human Leukocyte Antibody (HLA) identical living donor transplant recipient.

2. History of a positive cross-match with the donor.

3. Patients with a peak CDC PRA > 50% or a current CDC PRA > 25%.

4. Patients who have previously received a kidney transplant.

5. Active donor or recipient serology positive for human immunodeficiency virus (HIV), Hepatitis B virus (HBV), or Hepatitis C virus (HCV).

6. History of noncompliance.

7. History of chronic corticosteroid or immunosuppressive use except for inhaled corticosteroids to treat asthma. .

8. Multiple organ transplant recipient.

9. Patient with a urinary bladder that is absent or not functional (e.g. self catheterization) pretransplant.

10. Patient who does not agree to use effective birth control during the 6-month efficacy analysis.

11. Known contraindication to administration of rabbit antithymocyte globulin.

12. 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

13. Currently abusing drugs or alcohol or, in the opinion of the investigator, is at high risk for poor compliance.

14. 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Renal Transplant Rejection
• Transplants and Implants

Intervention

Drug:
• Thymoglobulin
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
• Thymoglobulin
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

Locations

Country	Name	City	State
United States	The Christ Hospital	Cincinnati	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
University of Cincinnati	Genzyme, a Sanofi Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite End Point of Acute Rejection, Graft Loss or Patient Death	Proportion of Patients Meeting the Composite End Point of Acute Rejection, Graft loss or Patient death	6 months	No
Secondary	Incidence of Treatment Failures: Defined as the Percentage of Patients That do Not Remain on Initial Therapy.		Ongoing	No
Secondary	Incidence of Infections		Not defined	No
Secondary	Need for Antilymphocyte Antibody Therapy to Treat Acute Rejection		Not defined	No
Secondary	Severity of Biopsy-proven Rejection Using Banff 97 Criteria		Not defined	No
Secondary	Serum Creatinine		Post-operative days 1-7, 30, 90 and 6 months	No
Secondary	Malignancy		Undefined	Yes