Estrogen for Reperfusion Injury in Kidney Transplant Patients
(PERT Trial)

Recruiting in Palo Alto (17 mi)

Overseen byMatthew Levine, MD, PhD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: University of Pennsylvania

Trial Summary

What is the purpose of this trial?

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.

Research Team

Matthew Levine, MD, PhD

Principal Investigator

University of Pennsylvania Health System

Eligibility Criteria

This trial is for women over 21 years old who have been on dialysis for at least a month and are about to receive a kidney transplant from a deceased donor. They must be able to follow the study's procedures and not have any history of blood clots, estrogen-sensitive cancers, recent heart attacks or strokes, previous organ transplants, or be on hormone therapies.

Inclusion Criteria

I have been on dialysis for at least 1 month before my transplant.

I am female.

I am getting a kidney transplant from a deceased donor with a KDPI over 40.

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Exclusion Criteria

You have experienced a severe allergic reaction or swelling to Premarin Intravenous therapy.

I have had cancer that is sensitive to estrogen like breast, endometrial, or ovarian cancer.

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

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Treatment Details

Interventions

Conjugated Estrogen (Hormone Therapy)
Normal saline (Other)

Trial OverviewThe study tests if intravenous estrogen given around the time of surgery can reduce kidney damage from ischemia reperfusion injury in female recipients of kidney transplants. Patients will either receive conjugated estrogen or normal saline as part of their treatment.

Participant Groups

2Treatment groups

Active Control

Placebo Group

Group I: Active ArmActive Control1 Intervention

Participants randomized to the active arm will receive a single infusion of conjugated estrogens at the time of admission if within 8 hours of the expected surgery time or at approximately 8 hours to the expected surgery time if admission is earlier than that. Participants will then receive two daily infusions of conjugated estrogens after transplant given at 8 hours after reperfusion of the transplanted kidney and 24 hours after the first post transplant dose (32 hours after reperfusion of the transplanted kidney).

Group II: Placebo ArmPlacebo Group1 Intervention

Participants randomized to the placebo arm will receive normal saline (0.9% sodium chloride) at the same rate as the active arm.