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.
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
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
A Safety, Tolerability, and Efficacy Study of VX-880 in Participants With Type 1 Diabetes
This study will evaluate the safety, tolerability and efficacy of VX-880 infusion in
participants with Type 1 diabetes mellitus (T1D) and impaired awareness of hypoglycemia (IAH)
and severe hypoglycemia.
Jon Odorico, MD
All
18 Years to 65 Years old
Phase 1/Phase 2
This study is NOT accepting healthy volunteers
NCT04786262
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Key
Inclusion Criteria:
• Clinical history of T1D with > 5 years of duration
• At least two episodes of documented severe hypoglycemia in the 12 months prior to
enrollment
• Stable diabetic treatment
• Consistent use of continuous glucose monitor (CGM) for at least 3 months before
Screening and willingness to use CGM for the duration of the study
Key
Exclusion Criteria:
• Prior islet cell transplant, organ transplant, or cell therapy
Other protocol defined Inclusion/Exclusion criteria may apply
Diabetes Mellitus, Type 1, Impaired Hypoglycemic Awareness, Severe Hypoglycemia, Other specified diabetes mellitus, Other, Transplant
This study measures the safety, feasibility, and efficacy of viral-specific T cells (VST)
against BK Virus (BKV) in adult kidney transplant recipients. Participants are expected to be
on study for 52 weeks.
Sandesh Parajuli
All
18 Years to 75 Years old
Phase 1
This study is also accepting healthy volunteers
NCT05042076
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Inclusion Criteria:
• Age18 ≤ 75 years
• Have BKV infection/viremia following kidney transplantation, where BKV viremia is
defined as positive BKV qPCR (≥ 250 copies)
• Have evidence of invasive BKV infection (BK Nephropathy)
• Experience one of the following:
• New, persistent and/or worsening BKV-related symptoms, signs and/or markers of
end organ compromise despite being on lower immunosuppressive medication
• Adverse effects of lower immunosuppressive medications (e.g., dnDSA, biopsy
proven rejection)
• Eligible Donor
• Provide Written informed consent
Exclusion Criteria:
• Non-kidney organ transplant recipient
• Patient with acute rejection of the kidney allograft at time of T-cell transfer
• Patient receiving steroids (>0.5 mg/kg body weight (BW) prednisone equivalent) at the
time of T-cell transfer
• Patient treated with Thymoglobulin (ATG), Alemtuzumab or T-cell immunosuppressive
monoclonal antibodies within 28 days prior to T-cell transfer
• Extra renal tissue invasive BK infection
• Concomitant enrollment in another clinical trial interfering with endpoints of this
study
• Any medical condition which could compromise participation in the study according to
the investigator's assessment
• Known HIV infection
• Female patient who is pregnant or breast-feeding, or adult of reproductive potential
not willing to use an effective method of birth control during study treatment Note:
Women of childbearing potential must have a negative urine pregnancy test at study
entry.
• Patients unwilling or unable to comply with the protocol or unable to give informed
consent
Donor Eligibility
• ≥ 18 years old
• Available and capable of undergoing a single standard 2 blood volume leukapheresis
• HLA Compatible (see Donor selection priority below):
• Original kidney transplant donor
• Fully HLA matched family member (6/6 HLA match considering HLA-A, HLA-B and
HLA-DRB1 genes)
• Partially matched family member (≥ 2/6 HLA match, considering HLA-A, HLA-B and
HLA-DRB1 genes)
• BK IgG seropositive
• Meets the criteria for donor eligibility defined in the UW Program for Advanced Cell
Therapy Standard Operating Policies and Procedures for Donor Evaluation and
Eligibility Determination for the Donation of Viral Specific T Cells, which is in
compliance with FACT standards for Immune Effector Cells, and 21 CFR 1271, subpart C.
• Provide written informed consent
Donor selection priority: The original kidney donor will be the first choice of donor
peripheral mononuclear cells. If the original donor is not available or does not meet all
donor eligibility criteria, alternative related donors will be selected, with preference
for fully matched related donors (6/6 HLA match, considering HLA-A, -B, and -DRB1 genes)
over related donors with partial HLA match (≥ 2/6 HLA match, considering HLA-A, -B, and
-DRB1 genes).
Note that if the selected donor is related, but not a biological parent or child of the
recipient (i.e., at least haploidentical), then high resolution testing of HLA-A and HLA-B
will be performed on donor and recipient (if high resolution HLA genotyping not already
available in the medical record). If the degree of matching at high resolution reveals a
less favorable match than an alternative donor, then prioritization of the alternative
donor will occur.
Kidney replaced by transplant, Other, Kidney Transplant Infection, BK Virus Infection, Infections, Immune System & Allergies, Kidney Disease & Urinary
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
A phase 3 randomized partial blind storage duration ranging study in patients undergoing
complex cardiac surgery that will compare the transfusion of cold stored platelets to
standard room temperature stored platelets. The primary objective is to establish that cold
stored platelets have a non-inferiority (or superiority) to room temperature platelets.
Eric Simon
All
29 Days to 84 Years old
Phase 3
This study is NOT accepting healthy volunteers
NCT04834414
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Inclusion Criteria:
• Age greater than 28 days and less than 85 years
• Planned complex cardiac surgery with planned use of cardiopulmonary bypass
Exclusion Criteria:
• Expected order for washed or volume reduced platelets
• Patient with known anti-platelet antibodies
• Platelet transfusion refractoriness due to anti-HLA antibodies
• Known or suspected pregnancy
• Previously randomized in this study
• Conscious objection or unwillingness to receive blood products
• Known IgA deficiency
• Known congenital platelet disorder
• Known congenital bleeding disorder
• Planned post-operative extracorporeal membrane oxygenation (ECMO), ventricular assist
device (VAD), and/or continuous renal replacement therapy (CRRT)/ hemodialysis
• Patients intended to receive whole blood either intra-operative or post-operative for
bleeding
• Platelet transfusion (of any type) within 24 hours prior to the date of surgery
• Pre-operative thrombocytopenia, defined as platelet count <75x10(9)/L, based on the
most recent labs completed within 72 hours prior to the date of surgery.
Acute Blood Loss, Complications of heart transplant, Congenital malformation of heart, unspecified, Heart failure, Other acute ischemic heart diseases, Other, Heart & Vascular
COVID Protection After Transplant - Sanofi GSK (CPAT-SG) Study (CPAT-SG)
An open label, non-randomized pilot study in kidney transplant recipients who received a
completed primary series and bivalent booster of mRNA based COVID-19 vaccine and have =<2500
U/mL SARS-CoV-2 S antibody concentration using the Roche Elecsys(R) anti-RBD assay. Up to 80
participants will be enrolled in this study. Eligible participants will receive a dose of the
Sanofi-GSK monovalent (B.1.351) CoV2 preS dTM-AS03 COVID-19 vaccine candidate..
The primary objective is to determine whether a booster dose of the Sanofi-GSK monovalent
(B.1.351) CoV2 preS dTM-AS03 COVID-19 vaccine will elicit an increased SARS-CoV-2 antibody
response in participants who have failed to maintain an antibody titer >2500 U/mL (using the
Roche Elecsys(R) anti-RBD assay) to 2 or more doses of mRNA based COVID-19 vaccine
Jacqueline Garonzik Wang
All
18 Years and over
Phase 2
This study is NOT accepting healthy volunteers
NCT05518487
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Inclusion Criteria:
1. Able to understand and provide informed consent
2. Individual ≥ 18 years of age.
3. Recipient of kidney transplant >=12 months prior to enrollment, without treated
allograft rejection in the 6 months preceding enrollment
4. Maintenance immunosuppressive regimen consisting of CNI and mycophenolate mofetil or
mycophenolate, with or without <= 5mg/day prednisone or equivalent
5. Received completed primary series (3 doses) of mRNA vaccine (either the Moderna
COVID-19 vaccine or Pfizer-BioNTech COVID-19 vaccine) as specified in the respective
package inserts
6. Receipt a COVID-19 bivalent mRNA booster (Moderna or Pfizer-BioNTech) >30 days prior
to enrollment.
7. Serum antibody titer up to 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(R) anti-SARS-CoV-2
S assay
8. Platelet count greater than 30,000/cu mm must be confirmed in participants with a
known history of bleeding disorder or thrombocytopenia (platelet count <50,000/cu mm)
9. A female participant is eligible to participate if she is not pregnant or
breastfeeding and one of the following conditions applies:
1. Is of non-childbearing potential. To be considered of non-childbearing potential,
a female must be post-menopausal for at least 1 year or surgically sterile
OR
2. Is of childbearing potential and agrees to use an effective contraceptive method
or abstinence for 12 weeks post vaccine and while taking mycophenolate
mofetil/mycophenolic acid
Exclusion Criteria:
1. Recipient of any number of doses of any COVID vaccine product other than the Moderna
COVID-19 vaccine or the Pfizer-BioNTech COVID-19 vaccine
2. Recipient of any organ other than a kidney
3. Known current or prior Donor Specific Antibody (DSA)
4. Any change in transplant immunosuppression regimen (drug or dose) in response to
suspected or proven rejection within the last 6 months
5. Known diagnosis of COVID-19 since last antibody test
6. Receipt of a monoclonal antibody product or convalescent plasma within the last 30
days
7. Known history of hypersensitivity to any of the vaccine components, or history of a
life-threatening reaction to a vaccine containing any of the same substances.
(components listed in Section 6, and the CoV2 and AS03 Investigator's Brochure)
8. Bleeding disorder, or receipt of anticoagulants in the past 21 days preceding
inclusion, contraindicating intramuscular (IM) vaccination based on Investigator's
judgment
9. Moderate or severe acute illness/infection (according to investigator judgment) on the
day of vaccination or febrile illness (temperature >=38.0°C [>=100.4°F]). A
prospective participant should not be included in the study until the condition has
resolved or the febrile event has subsided
10. Receipt of any vaccine in the 30 days preceding the study vaccine or planned vaccines
in the 30 days following the study vaccine
11. Estimated Glomerular Filtration Rate <30mL/min/1.73m^2
12. Receipt of any cellular depleting agent (e.g. Antithymocyte globulin (ATG), Rituximab,
Alemtuzumab, Cyclophosphamide) within 12 months preceding enrollment
13. Receiving systemic immunomodulatory medication(s) for any condition other than
transplant
14. Any uncontrolled active infection
15. Infection with human immunodeficiency virus (HIV)
16. Maintenance immunosuppressive regimen that includes anything other than a CNI,
mycophenolate/mycophenolate mofetil, and =< 5mg/day prednisone or equivalent
17. Recent (within one year) or ongoing treatment for malignancy, except for definitive
surgical treatment of localized skin cancers
18. Any unstable acute or chronic illness, treatments, or findings which, in the opinion
of the investigator, may pose additional risks from participation in the study, may
interfere with the c candidate's ability to comply with study requirements or may
impact the quality or interpretation of the data obtained from the study
COVID-19, Kidney Transplant, Kidney replaced by transplant, 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.
BIVV020 (SAR445088) n Prevention and Treatment of Antibody-mediated Rejection (AMR)
Primary Objectives:
- Cohort A: To evaluate the efficacy of BIVV020 in prevention of AMR
- Cohort B: To evaluate the efficacy of BIVV020 in treatment of active AMR
Secondary Objectives:
- To assess the overall efficacy of BIVV020 in prevention or treatment of AMR
- To characterize the safety and tolerability of BIVV020 in kidney transplant participants
- To characterize the pharmacokinetic (PK) profile of BIVV020 in kidney transplant
participants
- To evaluate the immunogenicity of BIVV020
Fahad Aziz
All
18 Years and over
Phase 2
This study is NOT accepting healthy volunteers
NCT05156710
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Inclusion Criteria:
-Participant intended to receive SOC therapy per Investigator's judgment and local
practice.
Cohort A: Participants with chronic kidney disease who will receive a kidney transplant
from a living or deceased donor.
Cohort B: Participants who are kidney transplant recipients diagnosed with active AMR.
• BMI ≤ 40 kg/m2.
• Contraceptive use by women during the treatment period, and for at least 49 weeks
after the last administration of IMP (BIVV020 + SOC arm participant) or last treatment
period visit (SOC arm participant).
• Contraceptive use by men during the treatment period, and for at least 49 weeks after
the last administration of IMP (BIVV020 + SOC arm participant) or last treatment
period visit (SOC arm participant).
Exclusion Criteria:
• Participants who are ABO incompatible with their donors.
• Participants with known active ongoing infection as per below:
1. Positive HIV.
2. Positive HBV.
3. HCV with detectable HCV RNA.
4. Within 4 weeks of first study intervention: any serious infection, or any active
bacterial infection, or any other infection which is clinically significant in
the option of the Investigator, unless it can be confirmed that infection was
cleared at least 3 days prior to first study intervention.
• History of active tuberculosis (TB) regardless of treatment.
• Participants with clinical diagnosis of systemic lupus erythematosus (SLE).
• Prior treatment with complement system inhibitor within 5 times the half-life.
• Current enrollment in any other clinical study where the last investigational study
treatment administration was within 5 half-lives from study intervention initiation.
The above information is not intended to contain all considerations relevant to a patient's
potential participation in a clinical trial.
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