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30 Participants Needed

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

Overseen ByJulia Lewandowski

Age: 18+

Sex: Female

Trial Phase: Phase 1 & 2

Sponsor: University of Pennsylvania

Must not be taking: Estrogen, Anti-estrogen

Disqualifiers: History of transplant, Hypercoagulable conditions, Estrogen sensitive cancer, others

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.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are already on estrogen or anti-estrogen therapy, you cannot participate in the trial.

What data supports the effectiveness of the drug Conjugated Estrogen for reducing reperfusion injury in kidney transplant patients?

Research suggests that estrogen can help protect against kidney damage that occurs when blood supply returns to the kidney after a transplant. This protective effect is thought to be due to estrogen's ability to reduce injury caused by the sudden return of blood flow, known as ischemia-reperfusion injury.¹ ² ³ ⁴ ⁵

Is estrogen treatment safe for kidney transplant patients?

Estrogen treatments have been studied for safety in various conditions, including kidney transplant patients. While they may offer protective benefits against kidney injury, there are potential side effects, such as increased risk of blood clots and heart issues, especially in patients with kidney disease. Careful dosing and monitoring are important to minimize risks.¹ ² ⁴ ⁶ ⁷

How is the drug Conjugated Estrogen unique for kidney transplant patients?

Conjugated Estrogen is unique for kidney transplant patients because it may help protect against reperfusion injury (damage caused when blood supply returns to tissue) by leveraging estrogen's protective effects, which are not fully understood but have shown promise in improving outcomes in female kidney transplant recipients.¹ ² ³ ⁴ ⁸

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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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Peri-operative Treatment

Participants receive a single infusion of conjugated estrogens at the time of admission or approximately 8 hours before surgery, followed by two daily infusions post-transplant

2 days

In-hospital treatment

Immediate Post-operative Monitoring

Participants are monitored for delayed graft function and creatinine levels immediately post-operative and on post-operative day three

3 days

Follow-up

Participants are monitored for safety and effectiveness after treatment, including creatinine levels on post-operative day ninety

90 days

Treatment Details

Interventions

Conjugated Estrogen
Normal saline

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.