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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up post-operative day three
Awards & highlights
PERT Trial 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.Check my eligibility
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.See study design
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.
PERT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been on dialysis for at least 1 month before my transplant.
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I am female.
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I am getting a kidney transplant from a deceased donor with a KDPI over 40.
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I am older than 21 years.
PERT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ post-operative day three and day ninety
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~post-operative day three and day ninety
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Glomerular filtration rate (GFR)
Secondary outcome measures
Delayed graft function (DGF)
Other outcome measures
Graft Failure
Creatinine
Creatinine
PERT 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.
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Who is running the clinical trial?
University of PennsylvaniaLead Sponsor
2,015 Previous Clinical Trials
42,873,996 Total Patients Enrolled
Matthew Levine, MD, PhDPrincipal InvestigatorUniversity of Pennsylvania Health System
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have experienced a severe allergic reaction or swelling to Premarin Intravenous therapy.I have been on dialysis for at least 1 month before my transplant.I have had cancer that is sensitive to estrogen like breast, endometrial, or ovarian cancer.I am female.I am getting a kidney transplant from a deceased donor with a KDPI over 40.You have a history of certain conditions that make your blood more likely to clot.I had a stroke or heart attack in the last 6 months.I am currently taking estrogen or anti-estrogen medications.I am older than 21 years.I cannot take certain blood thinning medication due to an allergy or other medical reasons.I have had a solid organ transplant.I am receiving a multi-organ transplant.You have a BMI higher than 40.I have had a deep vein thrombosis or pulmonary embolism in the past.My doctor thinks I can't handle a certain medicine dose during transplant.
Research Study Groups:
This trial has the following groups:- Group 1: Active Arm
- Group 2: Placebo Arm
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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