← Back to Search

Hormone Therapy

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

Phase 1 & 2

Waitlist Available

Led By Matthew Levine, MD, PhD

Research Sponsored by University of Pennsylvania

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Pre-existing dialysis dependence of at least 1-months duration at the time of transplant

Female gender

Must not have

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

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up post-operative day three

Awards & highlights

All Individual Drugs Already Approved

Approved for 10 Other Conditions

Summary

This trial will study the effects of estrogen on female kidney transplant patients in order to reduce ischemia perfusion injury.

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

Potential side effects may include reactions related to hormone therapy such as increased risk of blood clots, nausea, headache, and possible allergic reactions. The exact side effects will be monitored closely due to the novel application in this setting.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Select...

I am female.

Select...

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

Select...

I am older than 21 years.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

Select...

I am currently taking estrogen or anti-estrogen medications.

Select...

I have had a solid organ transplant.

Select...

I am receiving a multi-organ transplant.

Select...

I have had a deep vein thrombosis or pulmonary embolism in the past.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ post transplant day 90

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~post transplant day 90

This trial's timeline: 3 weeks for screening, Varies for treatment, and post transplant day 90 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Glomerular filtration rate (GFR)

Secondary study objectives

Delayed graft function (DGF)

Other study objectives

Graft Failure

Creatinine

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

Trial Design

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.

0 / 9Eligibility criteria met