Attenuating Ischemia Reperfusion Injury After Living Donor Renal Transplantation

This study has been terminated.
(FDA clinical hold, IND withdrawn.)
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Keith Melancon,MD, Georgetown University
ClinicalTrials.gov Identifier:
NCT01149993
First received: June 21, 2010
Last updated: January 9, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Kidney Transplantation
Renal Transplantation
Reperfusion Injury
Drug: Myfortic (mycophenolic acid)
Drug: Thymoglobulin (anti-thymocyte globulin)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Attenuating Ischemia Reperfusion Injury After Living Donor Renal Transplantation

Resource links provided by NLM:


Further study details as provided by Georgetown University:

Primary Outcome Measures:
  • reduction in ischemia reperfusion injury [ Time Frame: one year ] [ Designated as safety issue: No ]
    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 [ Time Frame: one year ] [ Designated as safety issue: No ]
    incidence of acute rejection, graft survival, patient survival, change in cylex values


Enrollment: 20
Study Start Date: June 2010
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: pre-transplant immunosuppression
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.
Drug: Myfortic (mycophenolic acid)
720mg twice a day for 7 days prior to transplantation
Drug: Myfortic (mycophenolic acid)
720mg twice a day after transplant
Drug: Thymoglobulin (anti-thymocyte globulin)
up to 25 mg will be infused into the renal artery of a donor kidney prior to transplantation into the recipient.
Drug: Thymoglobulin (anti-thymocyte globulin)
standard of care for Georgetown University Hospital: 1.5 mg/kg/day infused over 6 hours.
Experimental: pre-transplant induction
subjects in this arm will not receive any pre-transplant immunosuppression. However, the donor kidney will receive an infusion of Thymoglobulin prior to transplantation.
Drug: Myfortic (mycophenolic acid)
720mg twice a day after transplant
Drug: Thymoglobulin (anti-thymocyte globulin)
up to 25 mg will be infused into the renal artery of a donor kidney prior to transplantation into the recipient.
Drug: Thymoglobulin (anti-thymocyte globulin)
standard of care for Georgetown University Hospital: 1.5 mg/kg/day infused over 6 hours.
Active Comparator: standard of care
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
Drug: Myfortic (mycophenolic acid)
720mg twice a day after transplant
Drug: Thymoglobulin (anti-thymocyte globulin)
standard of care for Georgetown University Hospital: 1.5 mg/kg/day infused over 6 hours.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Must be able to provide written informed consent.
  2. All recipients of a kidney from a living donor only, either a de novo transplant, or re-transplant
  3. 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.
  4. Patients between 18-80 years of age

Exclusion Criteria:

  1. Recipients of multi-organ transplant
  2. Patients with known allergies of hypersensitivities to any of the drugs used in this protocol
  3. Recipients of kidneys from a deceased donor
  4. Recipients who are co-infected with Hepatitis B, Hepatitis C or HIV
  5. Women who are pregnant
  6. 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01149993

Locations
United States, District of Columbia
Georgetown University Hospital
Washington, District of Columbia, United States, 20007
Sponsors and Collaborators
Georgetown University
Novartis
Investigators
Principal Investigator: Joseph K Melancon, MD Georgetown University Hospital
  More Information

No publications provided

Responsible Party: Keith Melancon,MD, Director of kidney and pancreas transplantation, Georgetown University
ClinicalTrials.gov Identifier: NCT01149993     History of Changes
Other Study ID Numbers: 2009-496
Study First Received: June 21, 2010
Last Updated: January 9, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Georgetown University:
living donation
kidney transplantation
delayed graft function
ischemia reperfusion injury

Additional relevant MeSH terms:
Ischemia
Reperfusion Injury
Wounds and Injuries
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Postoperative Complications
Antilymphocyte Serum
Mycophenolate mofetil
Mycophenolic Acid
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 15, 2014