The Use of Peri-Operative Intravenous Estrogen for the Mitigation of Ischemia Reperfusion Injury in the Setting of Renal Transplantation

82378

Ischemia perfusion injury (IRI) is a major cause of organ injury during kidney transplantation. Currently there are no treatments for IRI other than dialysis. Preliminary studies in female mice have found protection from IRI when given short term estrogen supplements. This study will look at the effect of intravenous estrogen given peri-operatively to reduce the effect of IRI in female kidney transplant recipients.

2016-08-26

2025-01-31

2025-01-31

Active (not recruiting)

Early phase I

30

Inclusion Criteria: 1. Female gender 2. Age \> 21 years at time of transplant 3. Pre-existing dialysis dependence of at least 1-months duration at the time of transplant 4. Receiving a deceased donor renal transplant with KDPI \>40 5. Written informed consent obtained from subject and ability for subject to comply with the requirements of the study Exclusion Criteria: 1. History of solid organ transplant 2. Receiving a combined heart-kidney transplant, liver-kidney transplant, or other multi- visceral organ transplant 3. Personal history of deep vein thrombosis (DVT) or pulmonary embolism (PE) 4. 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 5. Personal history of an estrogen sensitive cancer (breast, endometrial, ovarian) 6. Personal history of arterial thromboembolic disease such as stroke or myocardial infarction in the 6 months prior to transplantation 7. Patient already on estrogen (including oral contraceptive pills) or anti-estrogen therapy for other indications 8. 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 9. 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 10. Pregnant and breast feeding patients will be excluded from the study due to the small risk of radiation associated with the DTPA renal scan 11. Patient body mass index (BMI) \> 40 12. Known anaphylactic reaction and/or angioedema to Premarin Intravenous therapy 13. 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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Parallel: Participants are assigned to one of two or more groups in parallel for the duration of the study', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 30, 'type': 'ESTIMATED'}}

2023-08-22