Intravenous Estrogen in Kidney Transplant Study

• Status: Recruiting
• Trial end date: 2022-01-31
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Pennsylvania
• Collaborator: Pfizer
• Treatments: Estrogens; Estrogens, Conjugated (USP)

Criteria

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

5. Receiving their first (primary) kidney transplant

6. Subjects must receive between 500-5000U intravenous systemic heparin during their kidney transplant

7. Subjects must receive between 2500-7500U subcutaneous heparin prophylaxis three times daily during hospital stay

8. Written informed consent obtained from subject and ability for subject to comply with the requirements of the study

Exclusion Criteria:

1. Receiving a non-primary (second, third, fourth, etc.) kidney transplant

2. Receiving a combined heart-kidney transplant, liver-kidney transplant, or other multi-visceral organ transplant

3. Receiving a live donor kidney transplant

4. Personal history of deep vein thrombosis (DVT) or pulmonary embolism (PE)

5. 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

6. Personal history of an estrogen sensitive cancer (breast, endometrial, ovarian)

7. Personal history of arterial thromboembolic disease such as stroke or myocardial infarction in the 6 months prior to transplantation

8. Patient already on estrogen (including oral contraceptive pills) or anti-estrogen therapy for other indications

9. 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

10. 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

11. Pregnant and breast feeding patients will be excluded from the study due to the small risk of radiation associated with the DTPA renal scan

12. Patient body mass index (BMI) > 40Kidney donor profile index (KDPI) < 40

13. Known anaphylactic reaction and angioedema to Premarin Intravenous therapy

14. 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