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Could estrogen shield transplanted kidneys?

NCT ID NCT03663543

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether giving estrogen through a vein during kidney transplant surgery can reduce damage to the new kidney. It includes 30 women who need dialysis and are getting a kidney from a deceased donor. The goal is to see if estrogen helps the kidney work better right after transplant.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2016

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

21 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Female gender 2. Age \> 21 years at time of transplant 3. Pre-existing dialysis dependence of at least 1-months duration at the time of transplant 4. Receiving a deceased donor renal transplant with KDPI \>40 5. Written informed consent obtained from subject and ability for subject to comply with the requirements of the study Exclusion Criteria: 1. History of solid organ transplant 2. Receiving a combined heart-kidney transplant, liver-kidney transplant, or other multi-visceral organ transplant 3. Personal history of deep vein thrombosis (DVT) or pulmonary embolism (PE) 4. Personal history of hypercoagulable condition including but not limited to Lupus Anticoagulant, Leiden Factor V Mutation, Prothrombin Gene Mutation, Protein C or S deficiency, or any other hypercoagulable condition considered by the attending transplant surgeon on clinical service or Data and Safety Monitoring Board (DSMB) to warrant exclusion from the study 5. Personal history of an estrogen sensitive cancer (breast, endometrial, ovarian) 6. Personal history of arterial thromboembolic disease such as stroke or myocardial infarction in the 6 months prior to transplantation 7. Patient already on estrogen (including oral contraceptive pills) or anti-estrogen therapy for other indications 8. Patient who is expected to not tolerate a dose of 500-5000U intravenous heparin at the time of transplant as determined by the transplant surgeon 9. Patient who has a contraindication or allergy to or is expected to not tolerate a dose of 2500-7500U subcutaneous heparin prophylaxis three times daily during hospital stay as determined by the transplant surgeon 10. Pregnant and breast feeding patients will be excluded from the study due to the small risk of radiation associated with the DTPA renal scan 11. Patient body mass index (BMI) \> 40 12. Known anaphylactic reaction and/or angioedema to Premarin Intravenous therapy 13. Presence of a condition or abnormality that in the opinion of the investigator or attending transplant surgeon primarily responsible for the patient's care would compromise the safety of the patient or the quality of the data.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

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