An Early Phase 1 interventional study of Treg in End Stage Renal Disease and Kidney Transplant, sponsored by Roberto Gedaly. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-06-24.
Sponsored by Roberto Gedaly · Early Phase 1, Interventional, and Treatment
This study will enroll individuals who have end stage renal disease and who are undergoing a solitary kidney transplant. This study is investigating/evaluating the safety and effectiveness of collecting, expanding and infusing a specific certain type of immune cell known as Regulatory T cells (Treg cells) to renal transplant recipients who are using Zortress (Everolimus) as immunosuppressive therapy.
Treg cells, once they have been expanded in the laboratory to help prevent kidney rejection. Treg cells are collected from a participant's blood through a procedure called apheresis. Treg cells are a type of white blood cells that are able to suppress the activity of other immune cells responsible for organ rejection. The investigator plans to enroll 12 participants at the University of Kentucky.
The purpose of this research study is to learn alternative ways to control the body's immune responses after renal transplantation. The investigator's goal is to prevent or reduce the side-effects of long-term immunosuppressive therapy.
By doing this study, the investigator hopes to learn how safe and effective infusing autologous Treg cells, after renal transplantation, to renal transplant recipients who are taking Zortress (Everolimus) to control the immune response.
Individuals who decide to take part in this research study and are eligible to start, will be followed for 1 year after their transplant. The research procedures will be conducted at the University of Kentucky Medical Center and require nine study visits. One of the study visits requires an overnight stay. Participants will be admitted to the University of Kentucky Center for Clinical and Translational Science (CCTS) inpatient research unit for this study visit. Depending on the frequency of an participant's post-transplant clinic visits, some of the study visits could be done at the same time as their regular clinic visits. If not, they will occur in the transplant clinic or in the University of Kentucky Center for Clinical and Translational Science (CCTS) outpatient research unit.
The total amount of time required for participation in the study will be up to 40 hours over 1 year. The total amount of blood taken for the study will be about 14 tablespoons (200ml/6.5 ounces) over 1 year.
STUDY PROCEDURES:
Blood Samples: These will be collected via a needle inserted into a vein in the arm.
Human immunodeficiency virus (HIV) and hepatitis testing: Test for HIV, Hepatitis B and Hepatitis C will be done as part of the participant's routine transplant evaluation. The results from these tests will be used to determine study eligibility at the pre-transplant study visit.
If any of these tests are positive, a qualified person will provide counseling to the participant. The State of Kentucky requires that researchers must report HIV, Hepatitis B and Hepatitis C positive test results to the local health department serving the jurisdiction in which the participant resides, and that the information reported must include the participant's full name, address, phone number, county of residence, and applicable disease/condition.
Apheresis: Apheresis is a procedure in which a machine receives blood removed from a participant's body and separates it into its various components: plasma, platelets, white blood cells and red blood cells. This procedure is done in the Apheresis Center in the Gill Heart Building at the UK Chandler Hospital. Depending on the reason for apheresis, one of these components is isolated and collected by the instrument, while the others are re-infused to the body.
In this particular research study the investigator is going to collect white blood cells to isolate Treg cells for expansion. The process of collecting white blood cells will take approximately 90 minutes. Once the blood cells are collected, the research team will isolate the Treg cells. These cells will be cultured in the laboratory under special conditions and will be expanded. After approximately 3 weeks in culture, the cells will have increased in number and be ready for the autologous Treg cell infusion.
Autologous Treg cell infusion: This will be a single intravenous (IV) infusion. A standard IV line will be started in a vein of the arm. The participant's own expanded regulatory T cells will be added to a sterile infusion solution, called Albumin, and administered to to the participant, and the infusion will take about 3 to 4 hours. Participant's vital signs will be monitored before, during, and after the infusion.
Renal Biopsy: Two renal biopsies (removal of a piece of kidney tissue) will be performed. The first one will be done in the operating room during the participant's renal transplant surgery. The biopsy will come from the new kidney prior to being transplanted. The second one will be done 6 weeks after the autologous Treg cell infusion and will be compared to the first one. The second renal biopsy is optional. If a participant agrees to the second biopsy it will be done as an outpatient procedure in the radiology department at the University of Kentucky. Using an ultrasound for guidance, the investigator will pass a larger needle through the skin to obtain a small sample of the transplanted kidney.
Physical Examination and Vital Sign Measurement: These will be done by a member of the study team. The participant's body temperature, heart rate, respiratory rate, and blood pressure will be measured and recorded.
Pregnancy Tests: A pregnancy test will be performed on women who could be pregnant prior to beginning the study and again prior to receiving the autologous Treg cell infusion to exclude the possibility of pregnancy. For study purposes women who could become pregnant must use two effective contraceptive starting prior to renal transplant through to visit 9.
2,108 studies on the registry are indexed under Kidney Failure, Chronic; 273 are open to participants now.
This study's enrollment of 9 is below the median of 57 across 1,569 interventional studies indexed under Kidney Failure, Chronic.
Browse Kidney Failure, Chronic studies →Roberto Gedaly is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This will be a single intravenous (IV) infusion. A participant's own expanded regulatory T cells will be added to Albumin, and administered to them. The amount of the solution will be approximately 300 ml and the infusion will take about 3 to 4 hours.
Drug: Treg
Collect white blood cells to isolate Treg cells for expansion. Once the blood cells are collected the cells will be cultured in the laboratory and will be expanded. After approximately 3 weeks in culture, the cells will have increased in number and be ready for the autologous Treg cell infusion.
Also known as: regulatory T cells
Changes in Tregs Infusion Toxicities
Laboratory measurement and observed toxicities immediately and with in 24 hours post infusion of Tregs.
Time frame: Immediately following Tregs infusion and again within 24 hours after Tregs infusion
Changes in Kidney Function
Creatinine level measurement
Time frame: for 2 years from the start of the study
Changes In Steroid Resistance Rejection Rates
Laboratory measurement
Time frame: 1, 6 and 12 months post Tregs infusion
Infectious Complications
Laboratory measurement
Time frame: for 2 years from the start of the study
Treg cell measurements within the allograft
Renal biopsy
Time frame: 6 to 12 weeks post transplant
Circulating T cell subset measurements
laboratory analysis
Time frame: twice a week for 4 weeks then weekly for 3 months
Plan to share: No
This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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Roberto Gedaly