Attenuating Ischemia Reperfusion Injury After Living Donor Renal Transplantation

Kidney Transplantation Clinical Trial

Official title:

Attenuating Ischemia Reperfusion Injury After Living Donor Renal Transplantation

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01149993
• Other study ID #: 2009-496
• Status: Withdrawn
• Phase: Phase 4
• First received: June 21, 2010
• Last updated: June 6, 2014
• Start date: June 2010
• Est. completion date: June 2012

Study information

• Verified date: June 2014
• Source: Georgetown University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Kidney Transplantation
• Renal Transplantation
• Reperfusion Injury

Intervention

Drug:
• Myfortic (mycophenolic acid)
720mg twice a day for 7 days prior to transplantation
• Myfortic (mycophenolic acid)
720mg twice a day after transplant
• 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.
• Thymoglobulin (anti-thymocyte globulin)
standard of care for Georgetown University Hospital: 1.5 mg/kg/day infused over 6 hours.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Georgetown University	Novartis

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	one year	No
Secondary	secondary outcomes	incidence of acute rejection, graft survival, patient survival, change in cylex values	one year	No