Intravenous Estrogen in Kidney Transplant Study (NCT03663543) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
Intravenous Estrogen in Kidney Transplant Study
United States30 participantsStarted 2016-08-26
Plain-language summary
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.
Who can participate
Age range21 Years
SexFEMALE
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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) 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