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Intravenous Estrogen in Kidney Transplant Study

NCT03663543 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-04-16

No results posted yet for this study

Summary

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.

Conditions

  • Ischemia Reperfusion Injury

Interventions

DRUG

Conjugated Estrogen

Dosing of conjugated estrogen will be given pre kidney transplant procedure and twice after reperfusion of the transplanted kidney.

DRUG

Normal saline

Dosing of normal saline will be given pre kidney transplant procedure and twice after reperfusion of the transplanted kidney.

Sponsors & Collaborators

Principal Investigators

  • Matthew Levine, MD, PhD · University of Pennsylvania Health System

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-26
Primary Completion
2027-01-31
Completion
2027-05-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03663543 on ClinicalTrials.gov