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A randomized double-blind placebo-controlled study to evaluate the efficacy and safety of Cinryze® (C1 esterase inhibitor [human]) for the treatment of acute antibody-mediated rejection in kidney transplant patients (Phase 3)

Clinical Trial Details

Certain types of antibodies in the blood may injure a transplanted kidney. Antibodies are types of proteins in the blood that help fight things that are not a part of your own body, like infections. Antibodies can also attack a transplanted kidney and may cause the body to start rejecting a transplanted kidney. This condition is called Antibody-Mediated Rejection (AMR). 

Antibodies activate a normal defense mechanism called “complement” and it is the complement proteins that damage the transplanted kidney. You have proteins normally in your blood to stop too much complement activity and one of those proteins is called C1 INH. Additional amounts of this complement inhibitor could potentially protect the transplanted kidney while your doctor is trying to remove the harmful antibodies you have developed against the transplanted kidney. 

Investigational in this study means that the drug has not been approved by regulatory authorities for AMR in kidney transplant patients. C1 INH purified and sterilized from blood donors is called CINRYZE™ and is currently approved by the Food and Drug Administration (FDA) for use in patients with another disease called hereditary angioedema (HAE). 

The purpose of this study is to help answer the following question(s): 
    
   • How safe is SHP616 and what are the side effects that might be related to it? 
   • Can SHP616 help subjects with AMR? 
   • How does SHP616 compare to placebo? 
    
About the study drug 

The study drugs used in this study are either SHP616 and/ or placebo. The C1 esterase inhibitor is a protein found in the blood that, at normal levels, helps regulate inflammation in the body. A placebo is a look-alike solution that has no active drug in it. In this study, the placebo will be normal saline (salt) solution. Both SHP616 and the placebo will be called “the study drug.” The study drug will be given to you in the form of a solution that will be administered into your vein by the study staff in 7 doses over a 13 day period. 

The study drug will be given in combination with two therapies currently used as part of the treatment regimen for AMR. These two standard therapies include intravenous immune globulin (IVIg) and plasmapheresis (filtering of the blood to remove antibodies). 

Currently, there is no FDA approved therapy for AMR, and many renal failure patients that have donor specific antibody (DSA) cannot be transplanted. Current treatment modalities, such as plasmapheresis or intravenous immunoglobulin (IVIg), may decrease DSA levels or inactivate it. These therapies, while not FDA-approved for this use in transplant patients, are used for an unapproved indication due to existing data that supports their use for AMR. This may not, however, address the tissue destruction that can occur. Furthermore, over time, transplanted kidney recipients can develop DSA and could lose their transplant to a chronic version of antibody mediated rejection of the organ. 

Key Eligibility: 

Inclusion Criteria: 

  • Have human leukocyte antigen (HLA) donor-specific antibody (DSA) identified at the time of diagnosis of AMR. 
  • Have a first qualifying episode of AMR in the participant's current renal allograft between 72 hours (h) and 12 months after transplant. 
  • Receive first dose of investigational product after 7 days after the kidney transplant procedure and within 7 days after the qualifying renal allograft biopsy procedure that was positive for AMR. 

Exclusion Criteria: 

  • Have received pediatric en bloc kidney transplant. 
  • Have primary Focal Segmental Glomerulosclerosis. 
  • Have prior or concurrent non-renal solid organ transplant or hematopoietic stem cell transplant (HSCT). 
  • Have a known neoplastic lesion in the transplanted allograft 
  • Have any ongoing infection 
  • Have ongoing treatment for hepatitis C virus (HCV) infection. 
  • Have had a recent myocardial infarction (MI) within the past 6 months and/or at the time of screening. 
  • Have a history of: abnormal bleeding, clotting events or disorders. 
  • Have a history of allergic reaction to CINRYZE or other blood products. 

Study contact by location

Upper East Side - Manhattan

Contact(s)

Melissa Eddie, RN
med9043@nyp.org

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

1509016529

ClinicalTrials.gov:

NCT02547220

Status

Open to Enrollment

Age Group

Adult

Sponsor