Intravenous Estrogen in Kidney Transplant Study (PERT)
Ischemia Reperfusion Injury
About this trial
This is an interventional treatment trial for Ischemia Reperfusion Injury
Eligibility Criteria
Inclusion Criteria:
- Female gender
- Age > 21 years at time of transplant
- Pre-existing dialysis dependence of at least 1-months duration at the time of transplant
- Receiving a deceased donor renal transplant with KDPI >40
- Written informed consent obtained from subject and ability for subject to comply with the requirements of the study
Exclusion Criteria:
- History of solid organ transplant
- Receiving a combined heart-kidney transplant, liver-kidney transplant, or other multi- visceral organ transplant
- Personal history of deep vein thrombosis (DVT) or pulmonary embolism (PE)
- Personal history of hypercoagulable condition including but not limited to Lupus Anticoagulant, Leiden Factor V Mutation, Prothrombin Gene Mutation, Protein C or S deficiency, or any other hypercoagulable condition considered by the attending transplant surgeon on clinical service or Data and Safety Monitoring Board (DSMB) t to warrant exclusion from the study
- Personal history of an estrogen sensitive cancer (breast, endometrial, ovarian)
- Personal history of arterial thromboembolic disease such as stroke or myocardial infarction in the 6 months prior to transplantation
- Patient already on estrogen (including oral contraceptive pills) or anti-estrogen therapy for other indications
- Patient who is expected to not tolerate a dose of 500-5000U intravenous heparin at the time of transplant as determined by the transplant surgeon
- Patient who has a contraindication or allergy to or is expected to not tolerate a dose of 2500-7500U subcutaneous heparin prophylaxis three times daily during hospital stay as determined by the transplant surgeon
- Pregnant and breast feeding patients will be excluded from the study due to the small risk of radiation associated with the DTPA renal scan
- Patient body mass index (BMI) > 40
- Known anaphylactic reaction and/or angioedema to Premarin Intravenous therapy
- Presence of a condition or abnormality that in the opinion of the investigator or attending transplant surgeon primarily responsible for the patient's care would compromise the safety of the patient or the quality of the data
Sites / Locations
- University of Pennsylvania
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Active Arm
Placebo Arm
Participants randomized to the active arm will receive a single infusion of conjugated estrogens at the time of admission if within 8 hours of the expected surgery time or at approximately 8 hours to the expected surgery time if admission is earlier than that. Participants will then receive two daily infusions of conjugated estrogens after transplant given at 8 hours after reperfusion of the transplanted kidney and 24 hours after the first post transplant dose (32 hours after reperfusion of the transplanted kidney).
Participants randomized to the placebo arm will receive normal saline (0.9% sodium chloride) at the same rate as the active arm.