Here are the studies that match your search criteria. If you are interested in participating, please reach out to the contact listed for the study. If no contact is listed, contact us and we'll help you find the right person.
Parenteral Ascorbic Acid Repletion in TransplantatIon (PARTI)
A single-center, randomized, double-blinded placebo-controlled trial is proposed to
investigate administration of supraphysiologic doses of ascorbic acid (vitamin C, AA) to
patients undergoing liver transplantation. Participants randomized to the intervention group
will receive intravenous (IV) AA 1500 mg every 6 hours for 48 hours. Participants randomized
to the control group will receive a saline placebo. The primary study outcome will be a
change in the Sequential Organ Failure Assessment (SOFA) score from baseline to three days
after the first dose of drug (dSOFA3). Secondary outcomes will include total vasopressor dose
in norepinephrine equivalents, 30-day and 1-year mortality, and serum AA levels.
Molly Groose
All
18 Years to 80 Years old
Phase 4
This study is NOT accepting healthy volunteers
NCT04756063
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Inclusion Criteria:
• The subject is scheduled to undergo primary deceased donor solidary liver
transplantation
Exclusion Criteria:
• Non-English speaking
• Known or believed to be pregnant
• Subject is a prisoner
• Impaired decision-making capacity (i.e., current encephalopathy)
• Known allergy to AA
• Concurrent organ transplantation (i.e., simultaneous liver-kidney transplantation)
• Planned veno-venous bypass use in the operating room
• Prior parenteral or oral AA repletion
• History of nephrolithiasis or oxaluria
• Vitamin C supplement use or administration (including HAT therapy) within the last
month prior to transplantation
• Glucose-6-phosphate dehydrogenase (G6PD) deficiency
• Sickle cell anemia
• Hereditary hemochromatosis
• Preoperative anuria or creatinine >2.5mg/dL in patient not on renal replacement
therapy
• Current enrollment in another research study
Liver Transplant Failure and Rejection, Other, Transplant, Digestive Health & Liver Disease
COVID Protection After Transplant-Immunosuppression Reduction (CPAT-ISR)
This study will enroll individuals who have:
- Completed primary series of mRNA COVID-19 vaccine, and
- An antibody response ≤ 2500 U/mL measured at least 30 days after the last dose of
vaccine.
This group of patients is at high risk for severe COVID-19 disease due to pharmacologic
immunosuppression and a high prevalence of non-transplant risk factors such as obesity and
diabetes.
Jacqueline Garonzik Wang
All
18 Years and over
Phase 2
This study is NOT accepting healthy volunteers
NCT05077254
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Inclusion Criteria:
Individuals who meet all the following criteria are eligible for enrollment as study
participants-
1. Able to understand and provide informed consent
2. Individual ≥18 years of age.
3. Recipient of a kidney or liver transplant ≥12 months prior to enrollment, without
allograft rejection in the 6 months preceding enrollment
4. Negative for anti-donor human leukocyte antigens (HLA) antibodies at screening
(Central Lab Test Determination).
5. Currently taking one of the following tacrolimus-based immunosuppressive regimens:
• Tacrolimus plus Mycophenolate Mofetil (MMF) or Mycophenolic Acid (MPA), with or
without a corticosteroid
• Tacrolimus with trough ≥ 5ng/mL with or without ≤5 mg of prednisone or equivalent
6. Received a minimum of 3 doses of either the Moderna coronavirus infectious disease 19
(COVID-19) vaccine or Pfizer-BioNTech COVID-19 vaccine
7. Participant must be ≥ 60 days after completion of primary vaccination or receipt of
the most recent booster dose with any authorized or approved monovalent or bivalent
COVID-19 vaccine at the time of study vaccine.
8. Serum antibody negative or low (titer ≤ 2500 U/mL) at ≥ 30 days from the last dose of
mRNA COVID-19 vaccine and ≥ 30 days following receipt of a monoclonal antibody product
or convalescent plasma for COVID-19, measured using the Roche Elecsys® anti-SARS-CoV-2
S assay.
9. Participant's transplant physician or midlevel practitioner who is clinically licensed
to prescribe and manage immunosuppression must confirm the participant's eligibility
based on medical history.
Exclusion Criteria:
Individuals who meet any of these criteria are not eligible for enrollment as study
participants-
1. Currently on an immunosuppressive regimen different from the three regimens described
in the Inclusion Criteria, for example (but not limited to) those including sirolimus,
everolimus, belatacept, or azathioprine
2. Recipient of any allograft other than a kidney or liver
3. Participant is pregnant
4. Any past history of Donor Specific Antibody (DSA) using local site standards
5. Prior receipt of the Moderna COVID-19 Vaccine 2023-2024 or Pfizer-BioNTech COVID-19
Vaccine 2023-2024.
6. Currently taking any systemic immunosuppressive agent, other than their prescribed
transplant immunosuppression
7. Known history of severe allergic reaction to any component of an authorized or
licensed COVID-19 vaccine
8. Thrombotic events, myocarditis, or pericarditis temporally associated with a prior
dose of COVID-19 vaccine
9. History of heparin-induced thrombocytopenia
10. Any change in transplant immunosuppression regimen (drug or dose) in response to
suspected or proven rejection within the last 6 months
11. More than minimal graft dysfunction, in accordance with study definition
12. Receipt of any cellular depleting agent (e.g. antithymocyte globulins (ATG),
rituximab, alemtuzumab, Cyclophosphamide) within 12 months preceding enrollment
13. Concurrent autoimmune disease at risk for exacerbation with immunosuppression
reduction
14. Any untreated active infection including BK viremia >10^4 copies
15. Infection with human immunodeficiency virus (HIV)
16. Recent (within one year) or ongoing treatment for malignancy with the exception of:
• Non- melanomatous skin cancer definitively treated by local therapy, and
• Definitively treated carcinoma-in-situ of the cervix (Stage 0 cervical cancer)
17. Treatment or prophylaxis of COVID-19 with a monoclonal antibody product or
convalescent plasma within 6 months preceding enrollment, or
18. Any past or current medical problems, treatments, or findings which, in the opinion of
the investigator, may:
• pose additional risks from participation in the study,
• interfere with the candidate's ability to comply with study requirements, or
• impact the quality or interpretation of the data obtained from the study.
Kidney Transplant Recipients, Liver Transplant Recipients, Complications of transplanted organs and tissue, Other immunodeficiencies, Other, Transplant
The objective of the OrganOx metra® New Enrollment Post-Approval Study is to collect data on
the post-transplant clinical outcomes of DBD and DCD donor livers preserved and assessed on
the OrganOx according to the current indications for use in the real-world setting.
David Al-Adra, MD
All
18 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT05526326
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Inclusion Criteria:
• Subject is 18 years of age or greater
• Subject is registered as an active recipient on the UNOS waiting list for liver
transplantation
• Subject, or legally authorized representative, is able and willing to give informed
consent and HIPAA authorization
• Subject is able and willing to comply with all study requirements (in the opinion of
the Investigator)
Exclusion Criteria:
• Subject requiring all of the following at the time of transplantation:
1. Oxygen therapy via a ventilator/respirator
2. Inotropic support
3. Renal replacement therapy
• Subject has acute/fulminant liver failure (UNOS status 1A)
• Subject planned to undergo simultaneous transplantation of more than one organ (e.g.,
liver and kidney) from the same liver donor
• Subject is pregnant (as confirmed by urine or serum pregnancy test) or nursing
• Concurrent enrollment in another clinical study. Subjects enrolled in clinical studies
or registries where only measurements and/or samples are taken (no test device or test
drug) are allowed to participate.
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