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Studies recruiting patients with Kidney Transplant

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A Trial of Transplanting Hepatitis C Kidneys Into Hepatitis C-Negative Kidney Recipients  (THINKER-NEXT Trial)

THINKER-NEXT study will include adult kidney transplant candidates without hepatitis C virus (HCV) infection on the transplant waiting list who will consent to kidney transplantation from a deceased donor infected with HCV, followed by treatment with a direct acting antiviral. 

Site PI: Dr. Raymond Chung

Contact: Dr. Meghan Sise (msise@mgb.org)

HOPE in Action Prospective Multicenter, Clinical Trial of Deceased HIVD+ Kidney Transplants for HIV+ Recipients

The primary objective of this study is to determine if an HIV-infected deceased kidney donor (HIVD+) transplant is safe with regards to major transplant-related and HIV-related complications.

Site PI: Dr. Nahel Elias

Contact: Lindsay Ventura

(lhventura@mgb.org)

A Dose Escalation Study in de Novo Renal Transplantation

The purpose of this study is to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of escalating doses of TCD601 when compared to rATG in de novo renal transplant patients.

Site PI: Dr. Nahel Elias

Contact: Lindsay Ventura

(lhventura@mgb.org)

Renal Allograft Tolerance Through Mixed Chimerism - SMC/MGH

The goal is to investigate the safety of the conditioning regimen, and its ability to induce donor/recipient lymphohematopoietic chimerism without Chimerism Transition Syndrome (CTS), which may result in donor-specific unresponsiveness (tolerance) to the renal allograft in the absence of maintenance immunosuppression.

Site PI: Dr. Tatsuo Kawai

Contact: Lindsay Ventura

(lhventura@mgb.org)

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.

Site PI: Dr. Hannah Gilligan

Contact: Lindsay Ventura

(lhventura@mgb.org)

A Safety, Pharmacokinetics and Efficacy Study of MAU868 for the Treatment of BK Viremia in Kidney Transplant Recipients

This clinical research study will test the safety and efficacy of the investigational medication MAU868, compared to a placebo, in patients who have had a kidney transplant who have active BK virus.

Site PI: Dr. Kassem Safa

Contact: Lindsay Ventura

(lhventura@mgb.org)

Lipid Management in Renal Transplant Recipients Using Evolocumab

Through this study, we would like to evaluate the safety and tolerability of Evolocumab (trade name: Repatha) which is a PCSK-9 inhibitor developed by Amgen, Inc in renal transplant recipients. The study would involve a total of 120 patients across 3 different hospitals in Boston, Massachusetts..

Site PI: Dr. Kassem Safa

Contact: Lindsay Ventura

(lhventura@mgb.org)

​An Efficacy and Safety Study of Imlifidase in Treatment of Antibody-Mediated Rejection in Kidney Transplant Patients

This clinical trial will investigate the efficacy and safety of Imlifidase (an IgG degrading protease) for the elimination of donor specific Anti-HLA antibodies and treatment of active antibody mediated rejection in kidney transplant recipients.

Site PI: Dr. Anil Chandraker

Contact: achandraker@bwh.harvard.edu

Study of Posoleucel (Formerly Known as ALVR105; Viralym-M) in Kidney Transplant Patients With BK Viremia

Phase 2 multicenter, randomized, double-blind, placebo-controlled, multiple dosing interval, 2-period study of the safety, tolerability and effectiveness of adoptively transferred posoleucel (ALVR105) multivirus-specific T cells in kidney transplant recipients with either high or low levels of BK viremia.

Site PI: Dr. Anil Chandraker

Contact: achandraker@bwh.harvard.edu

Lipid Management in Renal Transplant Recipients Using Evolocumab

 This clinical study aims to assess the safety and efficacy of Evolocumab (Repatha®), a PCSK9 inhibitor, for the reduction of LDL cholesterol in kidney transplant recipients.

Site PI: Dr. Anil Chandraker

Contact: achandraker@bwh.harvard.edu

Sotagliflozin Safety and Tolerability Among Renal Transplant Recipients (START)

This is an investigator-initiated, randomized controlled trial in adult kidney transplant recipients (N=50) with stable allograft function to assess: 1) the reversibility of the expected acute changes in eGFR with sotagliflozin (donated by Lexicon); 2) proportion of patients completing the protocol according to different eGFR reporting strategies (using a predefined algorithm to manage the expected pharmacological effect of sotagliflozin on eGFR); 3) safety and tolerability of sotagliflozin.

Site PI: Dr. Finnian McCausland

Contact email: (fmccausland@bwh.harvard.edu)

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