Ischemia Reperfusion InjuryPhase 1/2PERTNCT03663543
Intravenous Estrogen in Kidney Transplant Study
A Phase 1/2 study testing Conjugated Estrogen and Normal saline in people with Ischemia Reperfusion Injury, run by University of Pennsylvania at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Ischemia Reperfusion Injury
- What is being tested?
- Conjugated Estrogen and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Aug 2016to 1 May 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female gender
- Age > 21 years at time of transplant
- Pre-existing dialysis dependence of at least 1-months duration at the time of transplant
- Receiving a deceased donor renal transplant with KDPI >40
- Written informed consent obtained from subject and ability for subject to comply with the requirements of the study
Who cannot join
- History of solid organ transplant
- Receiving a combined heart-kidney transplant, liver-kidney transplant, or other multi-visceral organ transplant
- Personal history of deep vein thrombosis (DVT) or pulmonary embolism (PE)
- 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
- Personal history of an estrogen sensitive cancer (breast, endometrial, ovarian)
- Personal history of arterial thromboembolic disease such as stroke or myocardial infarction in the 6 months prior to transplantation
Show all 13Show fewer
- Patient already on estrogen (including oral contraceptive pills) or anti-estrogen therapy for other indications
- 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
- 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
- Pregnant and breast feeding patients will be excluded from the study due to the small risk of radiation associated with the DTPA renal scan
- Patient body mass index (BMI) > 40
- Known anaphylactic reaction and/or angioedema to Premarin Intravenous therapy
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: The Use of Peri-Operative Intravenous Estrogen for the Mitigation of Ischemia Reperfusion Injury in the Setting of Renal Transplantation
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.
Read the detailed description
Ischemia-reperfusion injury (IRI) is a major etiology of organ injury and dysfunction that occurs during transplantation. In renal transplantation, the clinical manifestation of IRI is delayed graft function (DGF), typically defined as a recipient requiring dialysis within the first week after transplant. At present, there are no directed treatments for IRI associated with kidney transplantation and resultant DGF, other than supportive care with dialysis. This represents an unmet clinical need. While dialysis enables the support of patients until DGF resolves, DGF is associated with increased medical costs, increased length of hospital stay, increased rates of readmission to the hospital after transplantation, increased rates of rejection, and decreased graft survival. Therapies to reduce IRI might alleviate clinical complications associated with DGF, reduce costs associated with transplantation, and ease organ shortages by facilitating use of more marginal organs.
Despite acceptance of gender disparities in IRI tolerance in animal systems, attempts to utilize hormonal manipulation in humans to achieve improved IRI tolerance have not been undertaken. In an effort to design such a translation, the investigators investigated if similar gender disparities exist in humans who have undergone kidney transplantation. After review of the United Network for Organ Sharing database, the investigators established that male recipient gender was highly associated with DGF. Then, the investigators demonstrated that manipulation of the pre-ischemic environment with short-term estrogen supplementation in female mice provides protection from renal IRI. As a logical next stop, the investigators propose hormonal manipulation with perioperative administration of intravenous conjugated estrogens as a novel therapeutic strategy to reduce the effect of IRI in female humans undergoing kidney transplantation. The investigators have designed an investigational new drug (IND) late phase I/early phase II prospective, single center, double blind, randomized, placebo-controlled trial to test the safety, feasibility, and efficacy of this therapy. If the administration of peri-operative intravenous administration has a positive impact on the rate of recovery of GFR after renal transplant and the inherent IRI, then this therapy would represent the first treatment for IRI and ultimately might reduce the incidence of DGF. Because DGF after kidney transplantation is associated with inferior transplant outcomes and increased costs,2 a therapy that mitigates the effect of IRI and consequently reduces the incidence of DGF not only might alleviate these complications but could also ease organ shortages by facilitating the use of more marginal organs. Moreover, if estrogen therapy does mitigate IRI in the setting of renal transplantation, it could be applied to other causes of renal IRI including supra-celiac clamping in trauma or vascular surgery or the use of cardiopulmonary bypass in cardiac surgery. Female adult subjects with a diagnosis of end stage renal disease who are dialysis dependent at the time of deceased donor renal transplantation and meet the inclusion and exclusion criteria will be eligible for participation in this study.
- Conditions
- Ischemia Reperfusion Injury
- Being tested
- Conjugated Estrogen, Normal saline
- Medical subject headings
- Reperfusion Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conjugated EstrogenDrug
Also called Premarin
Dosing of conjugated estrogen will be given pre kidney transplant procedure and twice after reperfusion of the transplanted kidney.
Normal salineDrug
Also called 0.9% sodium chloride
Dosing of normal saline will be given pre kidney transplant procedure and twice after reperfusion of the transplanted kidney.
| Study group | Role | What they receive |
|---|---|---|
| Active Arm | Active comparator | 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). Receives: Drug: Conjugated Estrogen |
| Placebo Arm | Placebo comparator | Participants randomized to the placebo arm will receive normal saline (0.9% sodium chloride) at the same rate as the active arm. Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glomerular filtration rate (GFR)
GFR (glomerular filtration rate) as calculated from a DTPA (Diethylenetriamine Pentaacetic Acid, a medication) renal scan.
Measured: Post-operative day three
Secondary outcomes (1)
Delayed graft function (DGF)
Measurement of urine creatinine clearance and serum creatinine.
Measured: Immediately post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2018
- Study start26 Aug 2016
- Primary completion31 Jan 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (30)Papers the sponsor has linked to this study.
- Other trials for Ischemia Reperfusion InjuryStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel: Participants are assigned to one of two or more groups in parallel for the duration of the study
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthew Levine, MD, PhD, Principal investigator, University of Pennsylvania Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03663543
- Sponsor's protocol ID
- 82378
- Acronym
- PERT
- Status last verified
- Apr 2026
- First submitted
- 27 Aug 2018
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Siedlecki A, Irish W, Brennan DC. Delayed graft function in the kidney transplant. Am J Transplant. 2011 Nov;11(11):2279-96. doi: 10.1111/j.1600-6143.2011.03754.x. Epub 2011 Sep 19.
PubMed 21929642Kher A, Meldrum KK, Wang M, Tsai BM, Pitcher JM, Meldrum DR. Cellular and molecular mechanisms of sex differences in renal ischemia-reperfusion injury. Cardiovasc Res. 2005 Sep 1;67(4):594-603. doi: 10.1016/j.cardiores.2005.05.005.
PubMed 15950202Kher A, Wang M, Tsai BM, Pitcher JM, Greenbaum ES, Nagy RD, Patel KM, Wairiuko GM, Markel TA, Meldrum DR. Sex differences in the myocardial inflammatory response to acute injury. Shock. 2005 Jan;23(1):1-10. doi: 10.1097/01.shk.0000148055.12387.15.
PubMed 15614124Hedges SJ, Dehoney SB, Hooper JS, Amanzadeh J, Busti AJ. Evidence-based treatment recommendations for uremic bleeding. Nat Clin Pract Nephrol. 2007 Mar;3(3):138-53. doi: 10.1038/ncpneph0421.
PubMed 17322926Wigginton JG, Pepe PE, Idris AH. Rationale for routine and immediate administration of intravenous estrogen for all critically ill and injured patients. Crit Care Med. 2010 Oct;38(10 Suppl):S620-9. doi: 10.1097/CCM.0b013e3181f243a9.
PubMed 21164406Bradley LD, Gueye NA. The medical management of abnormal uterine bleeding in reproductive-aged women. Am J Obstet Gynecol. 2016 Jan;214(1):31-44. doi: 10.1016/j.ajog.2015.07.044. Epub 2015 Aug 5.
PubMed 26254516Murray AW, Barnfield MC, Waller ML, Telford T, Peters AM. Assessment of glomerular filtration rate measurement with plasma sampling: a technical review. J Nucl Med Technol. 2013 Jun;41(2):67-75. doi: 10.2967/jnmt.113.121004. Epub 2013 May 8.
PubMed 23658207Ojo AO, Wolfe RA, Held PJ, Port FK, Schmouder RL. Delayed graft function: risk factors and implications for renal allograft survival. Transplantation. 1997 Apr 15;63(7):968-74. doi: 10.1097/00007890-199704150-00011.
PubMed 9112349Alves MG, Oliveira PJ, Carvalho RA. Substrate selection in hearts subjected to ischemia/reperfusion: role of cardioplegic solutions and gender. NMR Biomed. 2011 Nov;24(9):1029-37. doi: 10.1002/nbm.1640. Epub 2011 Jan 28.
PubMed 21274961Ardelt AA, Carpenter RS, Lobo MR, Zeng H, Solanki RB, Zhang A, Kulesza P, Pike MM. Estradiol modulates post-ischemic cerebral vascular remodeling and improves long-term functional outcome in a rat model of stroke. Brain Res. 2012 Jun 21;1461:76-86. doi: 10.1016/j.brainres.2012.04.024. Epub 2012 Apr 21.
PubMed 22572084Eckhoff DE, Bilbao G, Frenette L, Thompson JA, Contreras JL. 17-Beta-estradiol protects the liver against warm ischemia/reperfusion injury and is associated with increased serum nitric oxide and decreased tumor necrosis factor-alpha. Surgery. 2002 Aug;132(2):302-9. doi: 10.1067/msy.2002.125718.
PubMed 12219027Gabel SA, Walker VR, London RE, Steenbergen C, Korach KS, Murphy E. Estrogen receptor beta mediates gender differences in ischemia/reperfusion injury. J Mol Cell Cardiol. 2005 Feb;38(2):289-97. doi: 10.1016/j.yjmcc.2004.11.013. Epub 2005 Jan 20.
PubMed 15698835Peng X, Wang J, Lassance-Soares RM, Najafi AH, Sood S, Aghili N, Alderman LO, Panza JA, Faber JE, Wang S, Epstein SE, Burnett MS. Gender differences affect blood flow recovery in a mouse model of hindlimb ischemia. Am J Physiol Heart Circ Physiol. 2011 Jun;300(6):H2027-34. doi: 10.1152/ajpheart.00004.2011. Epub 2011 Mar 11.
PubMed 21398592Hu H, Wang G, Batteux F, Nicco C. Gender differences in the susceptibility to renal ischemia-reperfusion injury in BALB/c mice. Tohoku J Exp Med. 2009 Aug;218(4):325-9. doi: 10.1620/tjem.218.325.
PubMed 19638737Muller V, Szabo A, Viklicky O, Gaul I, Portl S, Philipp T, Heemann UW. Sex hormones and gender-related differences: their influence on chronic renal allograft rejection. Kidney Int. 1999 May;55(5):2011-20. doi: 10.1046/j.1523-1755.1999.00441.x.
PubMed 10231466
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Peri-Operative Intravenous Estrogen for the Mitigation of Ischemia Reperfusion Injury in the Setting of Renal Transplantation
- ClinicalTrials.gov ID
- NCT03663543
- Acronym / sponsor ID
- PERT / 82378
- Conditions
- Ischemia Reperfusion Injury
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 26 Aug 2016 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 10 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Ischemia-reperfusion injury (IRI) is a major etiology of organ injury and dysfunction that occurs during transplantation. In renal transplantation, the clinical manifestation of IRI is delayed graft function (DGF), typically defined as a recipient requiring dialysis within the first week after transplant. At present, there are no directed treatments for IRI associated with kidney transplantation and resultant DGF, other than supportive care with dialysis. This represents an unmet clinical need. While dialysis enables the support of patients until DGF resolves, DGF is associated with increased medical costs, increased length of hospital stay, increased rates of readmission to the hospital after transplantation, increased rates of rejection, and decreased graft survival. Therapies to reduce IRI might alleviate clinical complications associated with DGF, reduce costs associated with transplantation, and ease organ shortages by facilitating use of more marginal organs.
Despite acceptance of gender disparities in IRI tolerance in animal systems, attempts to utilize hormonal manipulation in humans to achieve improved IRI tolerance have not been undertaken. In an effort to design such a translation, the investigators investigated if similar gender disparities exist in humans who have undergone kidney transplantation. After review of the United Network for Organ Sharing database, the investigators established that male recipient gender was highly associated with DGF. Then, the investigators demonstrated that manipulation of the pre-ischemic environment with short-term estrogen supplementation in female mice provides protection from renal IRI. As a logical next stop, the investigators propose hormonal manipulation with perioperative administration of intravenous conjugated estrogens as a novel therapeutic strategy to reduce the effect of IRI in female humans undergoing kidney transplantation. The investigators have designed an investigational new drug (IND) late phase I/early phase II prospective, single center, double blind, randomized, placebo-controlled trial to test the safety, feasibility, and efficacy of this therapy. If the administration of peri-operative intravenous administration has a positive impact on the rate of recovery of GFR after renal transplant and the inherent IRI, then this therapy would represent the first treatment for IRI and ultimately might reduce the incidence of DGF. Because DGF after kidney transplantation is associated with inferior transplant outcomes and increased costs,2 a therapy that mitigates the effect of IRI and consequently reduces the incidence of DGF not only might alleviate these complications but could also ease organ shortages by facilitating the use of more marginal organs. Moreover, if estrogen therapy does mitigate IRI in the setting of renal transplantation, it could be applied to other causes of renal IRI including supra-celiac clamping in trauma or vascular surgery or the use of cardiopulmonary bypass in cardiac surgery. Female adult subjects with a diagnosis of end stage renal disease who are dialysis dependent at the time of deceased donor renal transplantation and meet the inclusion and exclusion criteria will be eligible for participation in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Parallel: Participants are assigned to one of two or more groups in parallel for the duration of the study
| Arm | Type | Receives |
|---|---|---|
| Active Arm | Active comparator | Drug: Conjugated EstrogenParticipants 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). |
| Placebo Arm | Placebo comparator | Drug: Normal salineParticipants randomized to the placebo arm will receive normal saline (0.9% sodium chloride) at the same rate as the active arm. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Female gender
- Age > 21 years at time of transplant
- Pre-existing dialysis dependence of at least 1-months duration at the time of transplant
- Receiving a deceased donor renal transplant with KDPI >40
- Written informed consent obtained from subject and ability for subject to comply with the requirements of the study
Key exclusion criteria (13 listed)
- History of solid organ transplant
- Receiving a combined heart-kidney transplant, liver-kidney transplant, or other multi-visceral organ transplant
- Personal history of deep vein thrombosis (DVT) or pulmonary embolism (PE)
- 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
- Personal history of an estrogen sensitive cancer (breast, endometrial, ovarian)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conjugated EstrogenAlso: PremarinDosing of conjugated estrogen will be given pre kidney transplant procedure and twice after reperfusion of the transplanted kidney. | Drug | Active Arm |
| Normal salineAlso: 0.9% sodium chlorideDosing of normal saline will be given pre kidney transplant procedure and twice after reperfusion of the transplanted kidney. | Drug | Placebo Arm |
Primary outcome
Glomerular filtration rate (GFR)
Time frame: Post-operative day three
GFR (glomerular filtration rate) as calculated from a DTPA (Diethylenetriamine Pentaacetic Acid, a medication) renal scan.
1 secondary outcome
Delayed graft function (DGF)
Time frame: Immediately post-operative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Background: PubMed 21929642Siedlecki A, Irish W, Brennan DC. Delayed graft function in the kidney transplant. Am J Transplant. 2011 Nov;11(11):2279-96. doi: 10.1111/j.1600-6143.2011.03754.x. Epub 2011 Sep 19.
- Background: PubMed 15950202Kher A, Meldrum KK, Wang M, Tsai BM, Pitcher JM, Meldrum DR. Cellular and molecular mechanisms of sex differences in renal ischemia-reperfusion injury. Cardiovasc Res. 2005 Sep 1;67(4):594-603. doi: 10.1016/j.cardiores.2005.05.005.
- Background: PubMed 15614124Kher A, Wang M, Tsai BM, Pitcher JM, Greenbaum ES, Nagy RD, Patel KM, Wairiuko GM, Markel TA, Meldrum DR. Sex differences in the myocardial inflammatory response to acute injury. Shock. 2005 Jan;23(1):1-10. doi: 10.1097/01.shk.0000148055.12387.15.
- Background: PubMed 17322926Hedges SJ, Dehoney SB, Hooper JS, Amanzadeh J, Busti AJ. Evidence-based treatment recommendations for uremic bleeding. Nat Clin Pract Nephrol. 2007 Mar;3(3):138-53. doi: 10.1038/ncpneph0421.
- Background: PubMed 21164406Wigginton JG, Pepe PE, Idris AH. Rationale for routine and immediate administration of intravenous estrogen for all critically ill and injured patients. Crit Care Med. 2010 Oct;38(10 Suppl):S620-9. doi: 10.1097/CCM.0b013e3181f243a9.
- Background: PubMed 26254516Bradley LD, Gueye NA. The medical management of abnormal uterine bleeding in reproductive-aged women. Am J Obstet Gynecol. 2016 Jan;214(1):31-44. doi: 10.1016/j.ajog.2015.07.044. Epub 2015 Aug 5.
- Background: PubMed 23658207Murray AW, Barnfield MC, Waller ML, Telford T, Peters AM. Assessment of glomerular filtration rate measurement with plasma sampling: a technical review. J Nucl Med Technol. 2013 Jun;41(2):67-75. doi: 10.2967/jnmt.113.121004. Epub 2013 May 8.
- Results publication: PubMed 9112349Ojo AO, Wolfe RA, Held PJ, Port FK, Schmouder RL. Delayed graft function: risk factors and implications for renal allograft survival. Transplantation. 1997 Apr 15;63(7):968-74. doi: 10.1097/00007890-199704150-00011.
- Results publication: PubMed 21274961Alves MG, Oliveira PJ, Carvalho RA. Substrate selection in hearts subjected to ischemia/reperfusion: role of cardioplegic solutions and gender. NMR Biomed. 2011 Nov;24(9):1029-37. doi: 10.1002/nbm.1640. Epub 2011 Jan 28.
- Results publication: PubMed 22572084Ardelt AA, Carpenter RS, Lobo MR, Zeng H, Solanki RB, Zhang A, Kulesza P, Pike MM. Estradiol modulates post-ischemic cerebral vascular remodeling and improves long-term functional outcome in a rat model of stroke. Brain Res. 2012 Jun 21;1461:76-86. doi: 10.1016/j.brainres.2012.04.024. Epub 2012 Apr 21.
- Results publication: PubMed 12219027Eckhoff DE, Bilbao G, Frenette L, Thompson JA, Contreras JL. 17-Beta-estradiol protects the liver against warm ischemia/reperfusion injury and is associated with increased serum nitric oxide and decreased tumor necrosis factor-alpha. Surgery. 2002 Aug;132(2):302-9. doi: 10.1067/msy.2002.125718.
- Results publication: PubMed 15698835Gabel SA, Walker VR, London RE, Steenbergen C, Korach KS, Murphy E. Estrogen receptor beta mediates gender differences in ischemia/reperfusion injury. J Mol Cell Cardiol. 2005 Feb;38(2):289-97. doi: 10.1016/j.yjmcc.2004.11.013. Epub 2005 Jan 20.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew Levine, MD, PhD principal investigator
University of Pennsylvania Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Conjugated Estrogen and Normal saline in people with Ischemia Reperfusion Injury, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glomerular filtration rate (GFR) (time frame: Post-operative day three). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03663543, which also lists 30 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.