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    Kidney and Pancreas Transplant Program

    Kidney and Pancreas Transplant ProgramOpens new window | Adult Clinical Trials Main Page

    Further protocol information can be found on the links below at ClinicalTrials.gov


    Active Trials

    Title: Evaluation of the Benefits and Risks in Maintenance Renal Transplant Recipients Following Conversion to Nulojix® (Belatacept)-Based Immunosuppression
    Description: The primary purpose is to assess the benefits and risks of changing from Cyclosporine or Tacrolimus to Belatacept between 6-36 months after kidney transplant
    Investigator: V. Ram Peddi, MD
    Eligibility: Subject between 18 and 75 years old who are recipients of a renal allograft from a living donor or a deceased donor between 6-36 months prior to enrollment
    Status: Active and Closed to enrollment
    Contact: Serena Lai, 415-600-1744, Email: LaiS@cpmcri.org about Study BMS 116

    Title: Evaluation of Acute Rejection Rates in de Novo Renal Transplant Recipients Following Thymoglobulin Induction, CNI-free, Nulojix (Belatacept)-Based Immunosuppression
    Description: A 2 year study evaluating the efficacy of the combination of Thymoglobulin induction, belatacept, everolimus and corticosteroid withdrawal vs standard of care in preventing acute rejection in adult kidney transplant recipients
    Investigator: V. Ram Peddi, MD
    Eligibility: Subjects 18 years and older with end stage renal disease scheduled to undergo a living or deceased donor renal transplant
    Status: Active and Closed to enrollment
    Contact: Serena Lai, 415-600-1744, Email: LaiS@cpmcri.org about Study BMS 177

    Title: Astagraf XL® to Understand the Impact of Immunosuppression on De Novo DSA Development and Chronic Immune Activation in Kidney Transplantation
    Description: This study will compare the incidence of a two-part composite endpoint consisting of de novo donor specific antibody formation or a designation of "immune activation " on peripheral blood molecular profiling in patients maintained on twice daily, immediate-release tacrolimus versus those maintained on Astagraf XL in the first two years post-transplant.
    Investigator: V. Ram Peddi, MD
    Eligibility: Subjects, 18 to 65 years old, who are recipients of a de novo kidney from a living or deceased donor
    Status: Active and open to enrollment
    Contact: Serena Lai, 415-600-1744, Email: LaiS@cpmcri.org about Study Astellas Astound

    Title: A Phase 3, Randomized, Double-blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of QPI-1002 for Prevention of Delayed Graft Function in Recipients of a Donation After Brain Death Older Donor Kidney Transplant
    Description: A 1 year study evaluating if QPI-1002 can be used to prevent delayed graft function in recipients of an older donor kidneys
    Investigator: V. Ram Peddi, MD
    Eligibility: Subjects, 18 years and older, with dialysis dependent renal failure (at least 2 months prior to transplantation) who are about to receive a kidney transplant from a deceased donor ≥ 45 years of age
    Status: Active and open to enrollment
    Contact: Serena Lai, 415-600-1744, Email: LaiS@cpmcri.org about Study Quark 306

    Title: Efficacy and Safety of Human Plasma-derived C1-esterase Inhibitor as add-on to Standard of Care for the Treatment of Refractory Antibody Mediated Rejection (AMR) in Adult Renal Transplant Recipients
    Description: This double-blind, randomized-withdrawal, placebo-controlled study in kidney transplant patients with AMR evaluates the efficacy and safety of human plasma-derived C1-esterase inhibitor as add-on to standard of care (IVIG).
    Investigator: V. Ram Peddi, MD
    Eligibility: Patients at least 18 years old with evidence of at least one DSA who has achieved a steady-state, post-transplant eGFR >40mL/min/1.73m2 or achieved a 50% increase in urine output with a 50% decrease in serum creatinine over the first 7 days post-transplant without dialysis, have biopsy-proven acute AMR per Banff 2015 criteria that is unresponsive to standard of care treatment are eligible for the study. Patients who have received over 2 weeks of dialysis before screening, have hepatobiliary disease, and active clinically significant bacterial or fungal infection are not eligible for this study.
    Status: Active and open to enrollment
    Contact: Alejandra Alvarez, (415) 600-1627, Email: AlvarA9@cpmcri.org about study

    Title: Study to Assess the Efficacy and Safety of Bleselumab in Preventing the Recurrence of Focal Segmental Glomerulosclerosis in de Novo Kidney Transplant Recipients
    Description: This phase 2a, randomized, open-label study assess the efficacy of bleselumab regimen compared with the standard of care regimen in the prevention of the recurrence of focal segmental glomurosclerosis.
    Investigator: V. Ram Peddi, MD
    Eligibility: Patients at least 18years old who has a biopsy-proven, pFSGS as a cause of ESRD in their native kidneys are eligible for the study. Patients who previously received an organ transplant and patients who will be receiving multi-organ or dual kidney transplants are not eligible for the study.
    Status: Active and open to enrollment
    Contact: Serena Lai, (415) 600-1744, Email LaiS@cpmcri.org about Study

    Title: A Randomized, Double Blind, Placebo Controlled Study to Assess the Safety, Tolerability, and Efficacy of MAU868 for the Prevention of Allograft-threatening BK Virus Infection in Kidney Transplant Recipients
    Description: This is a non-confirmatory, randomized, placebo-controlled, blinded, proof-of-concept study in kidney transplant recipients. Approximately 96 eligible subjects are planned to be randomized 2:1 to receive MAU868 or placebo. At least 78 subjects are expected to complete the study. The study will consist of a pre-treatment (screening) consenting period, a 24 week treatment period (consisting of 6 monthly i.v. doses of MAU868 or placebo) and a 24 week follow-up period. Subjects who complete the study per protocol will attend a total of 16 visits over a period of 48 weeks.
    Investigator: Ram Peddi M.D.
    Eligibility: Male or female recipients of a first or second kidney or kidney-pancreas transplant who weigh at least 30 kg and are at least 7 years of age (in the US, 18 years of age or above) at the time of transplantation.
    Status: Coming Soon
    Email: lais@cpmcri.org about the Novartis MAU868 BK Virus

    Updated April 2018