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Attenuating Ischemia Reperfusion Injury After Living Donor Renal Transplantation

Primary Purpose

Kidney Transplantation, Renal Transplantation, Reperfusion Injury

Status

Withdrawn

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Myfortic (mycophenolic acid)

Thymoglobulin (anti-thymocyte globulin)

About this trial

This is an interventional treatment trial for Kidney Transplantation focused on measuring living donation, kidney transplantation, delayed graft function, ischemia reperfusion injury

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Must be able to provide written informed consent.
All recipients of a kidney from a living donor only, either a de novo transplant, or re-transplant
All patients evaluated and listed with the United Network for Organ Sharing (UNOS) who are eligible to receive a kidney transplant under GUH's standard protocol.
Patients between 18-80 years of age

Exclusion Criteria:

Recipients of multi-organ transplant
Patients with known allergies of hypersensitivities to any of the drugs used in this protocol
Recipients of kidneys from a deceased donor
Recipients who are co-infected with Hepatitis B, Hepatitis C or HIV
Women who are pregnant
Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle or sexual orientation precludes intercourse with a male partner unless they agree to avoid pregnancy throughout the duration of the trial and for 3 months following the trial.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

pre-transplant immunosuppression

pre-transplant induction

standard of care

Arm Description

subjects in this arm will receive Myfortic 720mg twice daily for 7 days prior to transplantation. Intra-operatively, the donor kidney will receive an infusion of Thymoglobulin, prior to the transplantation.

subjects in this arm will not receive any pre-transplant immunosuppression. However, the donor kidney will receive an infusion of Thymoglobulin prior to transplantation.

subjects in this arm will not receive any pre-transplant immunosuppression, and the donor kidney will not receive an additional dose of Thymoglobulin prior to transplantation. This is the standard of care protocol for Georgetown University Hospital

Outcomes

Primary Outcome Measures

reduction in ischemia reperfusion injury

Monitor immediate graft functioning, mitochodrial membrane potential, serum creatinine, and cylex immunomonitoring to determine if pre-transplant immunosuppression, and an additional intra-operative dose of induction agent helps to reduce ischemic reperfusion injury.

Secondary Outcome Measures

secondary outcomes

incidence of acute rejection, graft survival, patient survival, change in cylex values

Full Information

NCT ID

NCT01149993

First Posted

June 21, 2010

Last Updated

June 6, 2014

Sponsor

Georgetown University

Collaborators

Novartis

1. Study Identification

Unique Protocol Identification Number

NCT01149993

Brief Title

Attenuating Ischemia Reperfusion Injury After Living Donor Renal Transplantation

Official Title

Attenuating Ischemia Reperfusion Injury After Living Donor Renal Transplantation

Study Type

Interventional

2. Study Status

Record Verification Date

June 2014

Overall Recruitment Status

Withdrawn

Why Stopped

FDA clinical hold, IND withdrawn.

Study Start Date

June 2010 (undefined)

Primary Completion Date

June 2012 (Actual)

Study Completion Date

June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Georgetown University

Collaborators

Novartis

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Patients undergoing living donor renal transplant will be asked to participate to determine whether pre-operative dosing of immunosuppressive medication, and the donor organ receiving an additional dose of antibody induction therapy helps to alleviate potential damage to the transplanted organ post-transplant. A number of lab tests will be done post-transplant to determine how well the kidney is functioning.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Kidney Transplantation, Renal Transplantation, Reperfusion Injury

Keywords

living donation, kidney transplantation, delayed graft function, ischemia reperfusion injury

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

pre-transplant immunosuppression

Arm Type

Experimental

Arm Description

Arm Title

pre-transplant induction

Arm Type

Experimental

Arm Description

subjects in this arm will not receive any pre-transplant immunosuppression. However, the donor kidney will receive an infusion of Thymoglobulin prior to transplantation.

Arm Title

standard of care

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Myfortic (mycophenolic acid)

Intervention Description

720mg twice a day for 7 days prior to transplantation

Intervention Type

Drug

Intervention Name(s)

Myfortic (mycophenolic acid)

Intervention Description

720mg twice a day after transplant

Intervention Type

Drug

Intervention Name(s)

Thymoglobulin (anti-thymocyte globulin)

Intervention Description

up to 25 mg will be infused into the renal artery of a donor kidney prior to transplantation into the recipient.

Intervention Type

Drug

Intervention Name(s)

Thymoglobulin (anti-thymocyte globulin)

Intervention Description

standard of care for Georgetown University Hospital: 1.5 mg/kg/day infused over 6 hours.

Primary Outcome Measure Information:

Title

reduction in ischemia reperfusion injury

Description

Time Frame

one year

Secondary Outcome Measure Information:

Title

secondary outcomes

Description

incidence of acute rejection, graft survival, patient survival, change in cylex values

Time Frame

one year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Must be able to provide written informed consent. All recipients of a kidney from a living donor only, either a de novo transplant, or re-transplant All patients evaluated and listed with the United Network for Organ Sharing (UNOS) who are eligible to receive a kidney transplant under GUH's standard protocol. Patients between 18-80 years of age Exclusion Criteria: Recipients of multi-organ transplant Patients with known allergies of hypersensitivities to any of the drugs used in this protocol Recipients of kidneys from a deceased donor Recipients who are co-infected with Hepatitis B, Hepatitis C or HIV Women who are pregnant Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle or sexual orientation precludes intercourse with a male partner unless they agree to avoid pregnancy throughout the duration of the trial and for 3 months following the trial.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Joseph K Melancon, MD

Organizational Affiliation

Georgetown University Hospital

Official's Role

Principal Investigator

12. IPD Sharing Statement

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Attenuating Ischemia Reperfusion Injury After Living Donor Renal Transplantation

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