Could estrogen shield transplanted kidneys?
NCT ID NCT03663543
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether giving estrogen through a vein during kidney transplant surgery can reduce damage to the new kidney. It includes 30 women who need dialysis and are getting a kidney from a deceased donor. The goal is to see if estrogen helps the kidney work better right after transplant.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2016
- Expected to finish
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May 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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21 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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) 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
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Other studies related to the condition(s) this trial covers.
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