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CIRTEN-Simultaneous Pancreas-Kidney Transplant Recipients
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
18 Years to 70 Years old
Phase 2/Phase 3
• 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
• 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
Kidney Pancreas Transplantation, Complications of kidney transplant, Transplant, Diabetes, Metabolism & Hormones
Envarsus in Delayed Graft Function (E-DGF) (E-DGF)
Envarsus XR is an extended release tacrolimus designed to deliver tacrolimus more consistently, thus avoiding large fluctuations of tacrolimus trough levels with Envarsus XR compared to immediate release tacrolimus. It is expected that patients with DGF on Envarsus XR will have more stable tacrolimus levels and facilitate early recover from DGF compared to immediate release tacrolimus.
Sandesh Parajuli, MD, MBBS
18 Years and over
Inclusion Criteria:1. Willing and able to provide written informed consent 2. Willing to comply with all study procedures and be available for the duration of the study 3. Male or female, at least 18 years of age 4. Documented diagnosis of DGF or need for dialysis or had dialysis within the first week of kidney transplant 5. Current treatment with tacrolimus based regimen or planned to start tacrolimus based immunosuppressive regimen 6. Females of childbearing potential must have a negative urine or serum pregnancy test prior to randomization and agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to randomization, for the duration of study participation, and for 7 days following completion of therapy.
• A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
• Has not undergone a hysterectomy or bilateral oophorectomy; or
• Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
Exclusion Criteria:1. History of hypersensitivity or allergy to any of the study drugs or drugs of similar chemical classes 2. Current use of non-tacrolimus based immunosuppressive regimen or no plan to start tacrolimus based regimen 3. Women who are or plan to become pregnant or breast-feeding during the study period 4. Not suitable for study participation due to other reasons at the discretion of the investigator 5. Major post-surgical complications requiring allograft nephrectomy 6. Multi-organ transplant recipients 7. Non kidney transplant recipients
Complications of kidney transplant, Delayed Graft Function, Transplant, Kidney Disease & Urinary
CAMPath and BELimumab for Transplant Tolerance in Sensitized Kidney Transplant Recipients (CAMPBEL)
The purpose of this research study is to determine whether kidney transplant recipients who receive belimumab (Benlysta®), combined with the standard of care medications for kidney transplant recipients, is safe and effective in helping prevent new donor specific antibodies (DSA) after transplantation. The presence of DSA increases the risk that the kidney transplant recipient's body will reject the new kidney. The investigators are doing this research because it is estimated that greater than 50% of kidney transplant failures are attributed to antibodies produced in the body, that attack the transplanted organ as a foreign object. DSA produced in the body after a kidney transplant, is thought to occur in 20-50% of patients and is associated with a low likelihood that the organ recipient's body will accept the new kidney. A major unmet need in the kidney transplant area are safe and effective therapies to prevent DSA after transplantation.
Arjang Djamali, MD
18 Years to 60 Years old
• Male or female subjects 18-60 years of age
• Planned to receive a deceased or living donor kidney transplant
• Sensitized patients: Positive sum DSA <1000, and/or PRA>0%.
• Subjects must be capable of understanding the purpose and risks of the study and must sign a statement of informed consent.
• Female subjects must be post-menopausal, surgically sterilized, or she and/or sexual partner must be willing to use an acceptable method of birth control with a <1% failure rate as stated in the product label from time of study consent, during study participation, and for 16 weeks after the last dose of the study agent (i.e., contraceptive subdermal implant of levonorgestrel or etonogestrel, intrauterine device or intrauterine system, combined estrogen and progestogen oral contraceptive, Injectable progestogen, contraceptive vaginal ring, percutaneous contraceptive patches, or abstinence) for the duration of the study. Male partner sterilization with documentation of azoospermia prior to the female subject's entry into the study, and this male is the sole partner for that subject. The documentation of male sterility can come from the site personnel's: review of subject's medical records, medical examination and/or semen analysis, or medical history interview provided by her or her partner. Note: Mycophenolate mofetil (MMF) affects the metabolism of oral contraceptives and may reduce their effectiveness. As such, women receiving MMF who are using oral contraceptives for birth control should employ an additional method (e.g., barrier method). Mycophenolate can cause fetal harm when administered to a pregnant female. Use of mycophenolate during pregnancy is associated with an increased risk of first trimester pregnancy loss and an increased risk of congenital malformations. Mycophenolate affects the metabolism of oral contraceptives and may reduce their effectiveness. As such, women receiving MMF who are using oral contraceptives for birth control should employ an additional method (e.g., barrier method) resulting in two reliable forms of contraception being used simultaneously before starting study treatments, during therapy, and for 6 weeks after stopping therapy; unless abstinence is the chosen method of contraception
• Female patients of childbearing potential must have a negative serum pregnancy test within 48 hours of transplant. Must be willing to use contraceptives from the time of study consent, during study participation, and for 16 weeks after the last dose of study agent. For sexually active men, condoms should be used during, and for at least 90 days after cessation of mycophenolate treatment. No sperm donation should be made during this period of time. For female partners of male subjects, it is recommended to use highly effective contraception during treatment and for 90 days after the last dose of mycophenolate
• No blood donation should be made by the study subjects during mycophenolate treatment and for at least 6 weeks after stopping mycophenolate treatment
• If stricter female or male contraception requirements are specified in the country-specific label for any study related therapies, they must be followed.
• Male subjects must agree to use an acceptable method for contraception for the duration of the study. Female patients of childbearing potential must have a negative serum pregnancy test within 48 hours of transplant. Must be willing to use contraceptives from the time of study consent, during study participation, and for 16 weeks after the last dose of study agent. Reproductive Status: Definition of Women of Child-Bearing Potential (WOCBP). WOCBP comprises women who have experienced menarche and who have not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or who are not post-menopausal (see definition below). Post-menopause is defined as:
• Women who have had amenorrhea for greater than or equal to 12 consecutive months (without another cause) and who have a documented serum follicle-stimulating hormone (FSH) level > 35 mIU/mL.
• Women who have irregular menstrual periods and a documented serum FSH level > 35 mIU/mL.
• Women who are taking hormone replacement therapy (HRT). The following women are WOCBP:
• Women using the following methods to prevent pregnancy: Oral contraceptives, other hormonal contraceptives (vaginal products, skin patches, or implanted or injectable products), or mechanical products such as intrauterine devices or barrier methods (diaphragm, condoms, spermicides).
• Women who are practicing abstinence from intercourse from 2 weeks prior to administration of the 1st dose of study agent until 16 weeks after the last dose of study agent (Sexual inactivity by abstinence must be consistent with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception)
• Women who have a partner who is sterile (e.g., due to vasectomy). WOCBP must be using an acceptable method of contraception to avoid pregnancy from the time of consent with <1% failure rate as stated in the product label throughout study participation, and for 16 weeks after the last dose of study drug in such a manner that the risk of pregnancy is minimized. Acceptable methods of contraception include: complete abstinence, any form of intra-uterine devices (without hormones), tubal sterilization or your partner has had a vasectomy. Other acceptable forms of birth control include choosing one hormonal and one barrier method or double-barrier methods. Barrier methods include Essure®, male or female condom, diaphragm with spermicide, shield, cap with spermicide, contraceptive sponge, and spermicidals. Hormonal methods include oral contraceptive pills, transdermal patches, vaginal rings, progesterone-only, and injections. Periodic abstinence (for example, calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
• These allowed methods of contraception are only effective when used consistently, correctly and in accordance with the product label. The investigator is responsible for ensuring subjects understand how to properly use these methods of contraception.
• WOCBP must have a negative serum or urine pregnancy test result (minimum sensitivity 25 IU/L or equivalent units of HCG) within 48 hours prior to transplant (and the first dose of study drug intraoperatively).Women must not be breast-feeding
• ABO incompatible donor kidney
• Deceased donor <5 years of age
• KDPI greater than or equal to 85%
• HLA identical or matched kidney
• Transplant other than kidney: has previously received a hematopoietic stem cell/marrow transplant or an organ transplant other than a kidney (with the exception of corneal transplantation)
• T- and/or B-cell positive crossmatch by complement dependent cytotoxicity or flow cytometry against the recipient
• Currently on any suppressive therapy for a chronic infection (such as tuberculosis, pneumocystis, cytomegalovirus, herpes simplex virus, herpes zoster and atypical mycobacteria).
• Hospitalization for treatment of infection within 60 days of Day 0
• Use of parenteral (IV or IM) antibiotics (antibacterials, antivirals, anti-fungals, or anti parasitic agents) within 60 days of Day 0
• Have a history of a primary immunodeficiency
• Uncontrolled infection or any other unstable medical condition that could interfere with the study
• Seropositive for HIV, HCV or HBV, except for hepatitis B surface antibody positive
• Have a significant IgG deficiency (IgG level < 400 mg/dl) Have an IgA deficiency (IgA level < 10 mg/dL)
• Prior therapy at any time: has ever received any of the following: a) B-cell targeted therapy (e.g., rituximab, other anti-CD20 agents, anti-CD2 [epratuzumab], anti-CD52 [alemtuzumab], BLyS-receptor fusion protein [BR3], TACI fragment, crystallizable (Fc), belimumab), or IV cyclophosphamide
• Live vaccines within 30 days
• Have a history of an anaphylactic reaction to parenteral administration of contrast agents, human or murine proteins or monoclonal antibodies
• Patients with a lymphocyte count less than 500/mm3
• Patients with evidence of current drug or alcohol abuse or dependence.
• Patients with venous access limitations likely to preclude monthly infusions
• Patients whom are unlikely to comply with scheduled study visits based on investigator judgment or has a history of substance abuse, psychiatric disorder or condition that may compromise communication with the investigator
• Myocardial infarction within 6 months prior to enrollment or New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiography evidence of acute ischemia or active conduction system abnormalities
• Diagnosis of liver cirrhosis or chronic viral hepatitis
• Female subject is pregnant or breast-feeding. Confirmation that the subject is not pregnant must be established by a negative serum beta-human chorionic gonadotropin (beta-hCG) pregnancy test result obtained during screening. Pregnancy testing is not required for post-menopausal or surgically sterilized women
• Patient has received other investigational drugs within 365 days before enrollment
• Serious medical or psychiatric illness likely to interfere with participation in this clinical study
• Have evidence of serious suicide risk including any history of suicidal behavior in the last 6 months and/or any suicidal ideation in the last 2 months or who in the investigator's judgment, pose a significant suicide risk
• Diagnosed or treated for malignancy within 5 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapy.
• Have any other clinically significant abnormal laboratory value in the opinion of the investigator
Kidney replaced by transplant, Transplant, Kidney Transplantation
A Dose-Escalation Study Evaluating Safety and Tolerability of Viral-Specific T Cells Against CMV in Adult Solid Organ Transplant Recipients
This study measures the tolerability of viral-specific T cells against Cytomegalovirus (CMV) in adult solid organ transplant (SOT) recipients. Participants are expected to be on study for 52 +/- 3 weeks.
Arjang Djamali, MD
18 Years to 75 Years old
Inclusion Criteria:1. Adult (age ≥ 18 and ≤75) patients suffering from CMV reactivation/infections following solid organ transplantation (e.g., liver, pancreas, lung, heart, and multi-solid organ)
• CMV reactivation/viremia defined as positive (>250 copies/mL) CMV qPCR(quantitative polymerase chain reaction) AND/OR
• Presence of symptoms secondary to CMV infection or evidence of invasive CMV infection (e.g. pneumonitis, colitis) AND ONE OF THE FOLLOWING CRITERIA:
• Absence of an improvement of viral load after ≥ 14 days of standard antiviral therapy with ganciclovir, valganciclovir or foscarnet (decrease by at least 1 log, i.e. 10-fold), or
• New, persistent and/or worsening CMV-related symptoms, signs and/or markers of end organ compromise while on anti-viral therapy with medications such as ganciclovir, acyclovir, valganciclovir, foscarnet, cidofovir, IVIG(Intravenous immunoglobulin), and/or letermovir, or
• Have contraindications or experience adverse effects of anti-viral therapy with medications such as ganciclovir, acyclovir, valganciclovir, foscarnet, cidofovir, IVIG, and/or letermovir, or
• Known resistance to the anti-viral medications ganciclovir, foscarnet and/or cidofovir based on molecular testing 2. Availability of eligible donor 3. Written informed consent given by patient
Exclusion Criteria:1. Patient with acute rejection of allograft at time of T-cell transfer 2. Patient receiving steroids (>0.5 mg/kg body weight (BW) prednisone equivalent) at the time of T-cell transfer 3. Patient treated with Thymoglobulin (ATG), Alemtuzumab or T-cell immunosuppressive monoclonal antibodies within 28 days 4. Patients with CMV retinitis 5. Concomitant enrollment in another clinical trial interfering with endpoints of this study 6. Any medical condition which could compromise participation in the study according to the investigator's assessment 7. Known HIV infection 8. 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 serum pregnancy test at study entry. 9. Patients unwilling or unable to comply with the protocol or unable to give informed consent Donor Eligibility Donor selection priority: The original donor will be the first choice as the source of T cells. If donation from the original donor is not possible (e.g. such as donor is unavailable or ineligible), then an alternative related donor will be selected, with preference for those who have full HLA matching in 6/6 loci over those with partial HLA matching (≥ 3/6 HLA loci). 1. 18 years old 2. Available and capable of undergoing a single standard 2 blood volume leukapheresis or donation of one unit of whole blood. 3. If the original transplant donor is not eligible, then an eligible fully matched or eligible haploidentical family member will be used as the donor. 4. Related donors must be at least partially HLA compatible, matching with recipient in at least 3/6 HLA loci (HLA-A, HLA-B and HLA-DRB1 will be considered for this). 5. Donors must be CMV IgG seropositive. 6. Donors must show CMV T-cell activation after incubation with MACS GMP PepTivator Peptide Pools of CMV pp65 before undergoing leukapheresis. 7. Donor must meet the criteria for donor selection defined in the UWHC Hematopoietic Stem Cell Transplant Program Standard Operating Procedure and in FACT standards, which comply with 21 CFR 1271, subpart C. 8. Donor must provide written informed consent.
Cytomegaloviral disease, Kidney replaced by transplant, Cytomegalovirus Infections, Solid Organ Transplant
Surveillance HeartCare® Outcomes Registry (SHORE)
This is an observational registry to assess the clinical utility of surveillance using HeartCare testing services, in association with clinical care of heart transplant recipients.
15 Years and over
Inclusion Criteria:1. Patients who are 15 years of age or older at the time of blood draw. 2. Received a heart transplant (primary or repeat) 3. Patients who have HeartCare initiated within 3 months post-transplant
Exclusion Criteria:1. Patients who are pregnant at the time of blood draw.
Heart Transplant Rejection, Heart transplant rejection, Heart & Vascular, Transplant
Clazakizumab for the Treatment of Chronic Active Antibody Mediated Rejection in Kidney Transplant Recipients (IMAGINE)
This trial investigates the efficacy and safety of clazakizumab [an anti-interleukin (IL)-6 monoclonal antibody (mAb)] for the treatment of CABMR in recipients of a kidney transplant.
Arjang Djamali, MD
18 Years to 70 Years old
• Inclusion criteria: 1. Age 18-70 years. 2. Living donor/deceased donor kidney transplant recipients ≥6 months from time of transplant. 3. Diagnosis of CABMR determined by kidney biopsy and the presence of HLA DSA using single-antigen bead-based assays. NOTE: If conducted within 6 months (+3 weeks) of the start of the screening period, the biopsy and DSA analysis do not need to be repeated at screening. To be considered for determination of study eligibility, the biopsy and DSA analysis must be performed at least 2 months ± 2 weeks after the end of any prior treatment for ABMR (including CABMR) or TCMR, in order to show continuing CABMR and presence of HLA DSA. In addition, treatments for ABMR or TCMR are not allowed within 3 months of the start of screening. The following histopathologic and serologic diagnostic criteria (based on Banff 2015 criteria [Loupy et al, 2017]) must be met for inclusion:
• Morphologic evidence of chronic tissue injury, as demonstrated by TG (cg>0). Biopsies without evidence of chronic tissue injury on light microscopy, but with glomerular basement membrane double contours on electron microscopy (cg1a) are eligible.
• Evidence of current/recent antibody interaction with vascular endothelium, including 1 or more of the following.
• Linear C4d staining in peritubular capillaries or medullary vasa recta (C4d2 or C4d3 by immunofluorescence on frozen sections, or C4d > 0 by immunohistochemistry on paraffin sections).
• At least moderate microvascular inflammation ([g + ptc] ≥ 2) in the absence of recurrent or de novo glomerulonephritis, although in the presence of acute TCMR, borderline infiltrate, or infection, ptc ≥ 2 alone is not sufficient and g must be ≥ 1. NOTE: The local pathologist's diagnosis must be reviewed by a central pathologist to confirm eligibility for entry into the study. Biopsies with other histopathologic changes (eg, BKV nephropathy or recurrent glomerulonephritis) may be eligible if concurrent CABMR changes (as detailed above) are present and determined to be the predominant cause of renal dysfunction. 4. Serologic evidence of circulating DSA to HLA. NOTE: The local laboratory DSA results must be reviewed and confirmed by the central HLA reviewer during the screening period.
• Exclusion criteria: 1. Multi-organ transplant recipient (except for simultaneous kidney-pancreas or previous multiple kidney transplants) or cell transplant (islet, bone marrow, stem cell) recipient. 2. Treatment for ABMR (including CABMR) or TCMR within 3 months of the start of screening. 3. Received T cell depleting agents (e.g., alemtuzumab, anti-thymocyte globulin) within 3 months of the start of screening. 4. Pregnant, breastfeeding, or unwillingness to practice adequate contraception. 5. History of active tuberculosis (TB). 6. History of human immunodeficiency virus (HIV) infection or positive for HIV. 7. Seropositive for hepatitis B surface antigen (HBsAg) 8. Hepatitis C virus (HCV) RNA positive.
Antibody-mediated Rejection, Kidney transplant rejection
Inducing Graft Tolerance in HLA Haplotype Matched Related and 3 Ag Matched Unrelated Living Donor Kidney Transplantation (CIRM)
This research study is to determine if donor blood stem cells given after living, related, HLA antigen (Ag) haplotype match or living, unrelated donor kidney transplantation. Minimal HLA antigen matching will include matching of 2 HLA antigens that can be either HLA A, B, and /or DR. This research will change the immune system such that immunosuppressive drugs can be completely withdrawn or reduced to minimal dose without kidney rejection.
18 Years to 65 Years old
Early Phase 1
Inclusion Criteria:1. All consenting adults (18 years of age) living donor renal transplant recipients at Stanford University Medical Center who have a one haplotype match donor. 2. Patients who agree to participate in the study and sign an Informed Consent. 3. Patients who have no known contraindication to administration of rabbit ATG or radiation. 4. Males and females of reproductive potential who agree to practice a reliable form of contraception for at least 24 months posttranplant.
Exclusion Criteria:1. Previous treatment with rabbit ATG or known allergy to rabbit proteins. 2. History of malignancy with the exception of non-melanoma skin malignancies. 3. Pregnant women or nursing mothers. 4. Serological evidence of HIV, Hepatitis B or Hepatitis C infection. 5. Seronegative for Epstein-Barr virus , if donor is seropositive. 6. Leukopenia (with a white blood cell count < 3000/mm3) or thrombocytopenia (with a platelet count < 100,000/mm3) 7. Panel Reactive antibody greater then 20% or demonstration of donor specific antibody (DSA). 8. Prior organ transplantation. 9. High risk of primary kidney disease recurrence (i.e. primary FSGS).
Transplant, Kidney replaced by transplant, Immune Tolerance