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Attenuating Ischemia Reperfusion Injury After Living Donor Renal Transplantation

Information source: Georgetown University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Kidney Transplantation; Renal Transplantation; Reperfusion Injury

Intervention: Myfortic (mycophenolic acid) (Drug); Myfortic (mycophenolic acid) (Drug); Thymoglobulin (anti-thymocyte globulin) (Drug); Thymoglobulin (anti-thymocyte globulin) (Drug)

Phase: Phase 4

Status: Withdrawn

Sponsored by: Georgetown University

Official(s) and/or principal investigator(s):
Joseph K Melancon, MD, Principal Investigator, Affiliation: Georgetown University Hospital

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.

Clinical Details

Official title: Attenuating Ischemia Reperfusion Injury After Living Donor Renal Transplantation

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

Primary outcome: reduction in ischemia reperfusion injury

Secondary outcome: secondary outcomes

Eligibility

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

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.

Locations and Contacts

Additional Information

Starting date: June 2010
Last updated: June 6, 2014

Page last updated: August 23, 2015

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