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This is a Phase II/III, Single-center, Prospective, Open-label, Single Arm Study of 30
Simultaneous Kidney Pancreas recipients who received a transplant at least 3 months, but no
more than 5 years prior, with a history of tremors following transplantation.
Jon Odorico, MD
All
18 Years to 70 Years old
Phase 2/Phase 3
This study is NOT accepting healthy volunteers
NCT03769298
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Inclusion Criteria:
• Adult, 18-70 years of age
• Participant must be able to understand and provide consent
• History of Diabetes Type 1 or Insulin-Dependent Diabetes Type 2 with Chronic Kidney
Disease (CKD)
• Recipient of a Simultaneous Pancreas Kidney (SPK) transplant, 3- 60 months prior to
screening, per Principal Investigator's discretion.
• Have a history of tremors following transplantation
• Stable pancreas allograft function as evidenced by no requirement of exogenous insulin
or oral anti-diabetic agents and stable pancreatic enzymes
• Stable kidney allograft function
• Currently taking Immediate-Release (IR) tacrolimus
• Women of child-bearing potential (WOCP) must have a negative pregnancy test at the
time of study entry
Exclusion Criteria:
• Currently maintained on an extended-release tacrolimus immunosuppressive regimen
• Previous history of tremors prior to transplantation
• Solitary pancreas transplant recipients
• History of solid organ transplant other than a kidney or pancreas
• Uncontrolled concomitant infection at the discretion of the investigator
• Presence of Donor Specific Antibodies
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
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