30 Participants Needed

Estrogen for Reperfusion Injury in Kidney Transplant Patients

(PERT Trial)

MC
MK
JL
Overseen ByJulia Lewandowski

What You Need to Know Before You Apply

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.

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.12345

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.12467

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.12478

Who Is on the Research Team?

ML

Matthew Levine, MD, PhD

Principal Investigator

University of Pennsylvania Health System

Are You a Good Fit for This Trial?

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.
See 2 more

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
See 10 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

  • Conjugated Estrogen
  • Normal saline
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Active Control
Placebo Group
Group I: Active ArmActive Control1 Intervention
Group II: Placebo ArmPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials
2,118
Recruited
45,270,000+

Citations

The Selective Estrogen Receptor Modulator, Raloxifene, Is Protective Against Renal Ischemia-reperfusion Injury. [2022]
Two routes of hormonal replacement therapy in symptomatic menopausal women after kidney transplantation. [2013]
Effects of progesterone and selective oestrogen receptor modulators on chronic allograft nephropathy in rats. [2013]
Combined oral contraception in women after renal transplantation. [2013]
Sex and the single transplanted kidney. [2020]
Protective effect of estradiol copreservation against kidney ischemia-reperfusion injury. [2022]
Estrogen replacement therapy: implications for postmenopausal women with end-stage renal disease. [2019]
Sex hormones in women with kidney disease. [2022]
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