Intravenous Estrogen in Kidney Transplant Study

Running, not enrolling · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Ischemia Reperfusion Injury

In brief

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.

Key facts

Study ID

NCT03663543

Run by

University of Pennsylvania

People needed

30

Starts

2016-08-26

Expected to finish

2027-05-01

Last updated by the study team

2026-04-16

Who can join

Age: 21 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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
• 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.

Where it is running

• University of Pennsylvania — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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