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 range
21 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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
. 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