A Multicenter Study to Evaluate the Efficacy and Safety of Cinryze® for the Treatment of Acute Antibody-mediated Rejection in Participants With Kidney Transplant



Status:Recruiting
Healthy:No
Age Range:18 - 70
Updated:4/6/2019
Start Date:May 20, 2016
End Date:May 30, 2029
Contact:Shire Contact
Email:clinicaltransparency@shire.com
Phone:+1 866 842 5335

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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

The main purpose of the study is to evaluate the efficacy of CINRYZE administered with
plasmapheresis, plasma exchange, or immune adsorption treatments and sucrose-free
immunoglobulin (IVIg) for the treatment of acute antibody-mediated rejection (AMR) of renal
allograft in kidney transplant recipients as measured by the proportion of participants with
new or worsening transplant glomerulopathy (TG) at 6 months after treatment initiation.


Inclusion Criteria:

1. Be greater than or equal to (>=) 18 and less than or equal to (<=) 70 years of age.

2. Weigh >= 45 kg with a body mass index (BMI) less than (<) 35 kilogram (kg)/meter (m)^2
at screening.

3. Have human leukocyte antigen (HLA) donor-specific antibody (DSA) identified at the
time of diagnosis of AMR. If it is anticipated that the local DSA results will not be
available within the screening period, previously obtained local DSA results can be
used to assess eligibility, if obtained after kidney transplant and within 30 days
prior to the qualifying AMR episode. In any instance, a local DSA test should still be
performed at the time of AMR diagnosis.

4. Have a first qualifying episode of AMR in the participant's current renal allograft
between 72 hours (h) and 12 months after transplant defined by a renal allograft
biopsy demonstrating neutrophil and/or monocyte infiltration in the peritubular
capillaries (PTC) and/or glomeruli with or without evidence of 4th complement protein
degradation product (C4d) deposition by immunohistopathology according to 2013 Banff
criteria.

5. Have achieved adequate renal function defined as: Pre-AMR baseline estimated
glomerular filtration rate calculated by the Modification of Diet in Renal Disease
(eGFRMDRD) >=20 millilitre (mL)/minute (min) /1.73m^2 for a qualifying AMR episode
occurring <=21 days after transplant or pre-AMR baseline eGFRMDRD >=30 mL/min/1.7m^2
for a qualifying AMR episode occurring greater than (>) 21 days after transplant. The
pre-AMR baseline is the highest eGFRMDRD value obtained following the kidney
transplant and within 30 days prior to the qualifying AMR episode. If more than 1
eGFRMDRD value is available, a mean of the 2 highest values (at least 1 day apart and
both prior to the AMR episode) will be used as the pre-AMR baseline value. If no
eGFRMDRD was obtained within 30 days prior to biopsy, it can be evaluated within a 60
day period.

6. 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.

7. Be informed of the nature of the study and provide written informed consent before any
study-specific procedures are performed.

8. If female and of child-bearing potential, must have a negative urine pregnancy test
confirmed by a negative serum beta human chorionic gonadotropin (beta-HCG) pregnancy
test at the Screening Visit and must have a negative urine pregnancy test at the Day 1
visit.

9. Agree to comply with any applicable contraceptive requirements of the protocol.

Exclusion Criteria:

1. Have received pediatric en bloc kidney transplant.

2. Have primary Focal Segmental Glomerulosclerosis, rapidly progressive
glomerulonephritis, membrano-proliferative glomerulonephritis type 1 (including C3
glomerulopathy), "dense deposit disease", or thrombotic microangiopathy as the cause
of native kidney failure.

3. Have prior or concurrent non-renal solid organ transplant or hematopoietic stem cell
transplant (HSCT) or have more than 2 completed kidney transplant procedures (note: 1
double kidney transplant procedure is considered to be 1 procedure).

4. Have a known neoplastic lesion in the transplanted allograft

5. Have, any ongoing infection that causes hemodynamic compromise or as determined by the
investigator, any surgical or medical condition that could interfere with the
administration of investigational product, interpretation of study results, or could
compromise participant safety, including (as determined by the transplanting surgeon
and documented in the operative report) any major technical complications of the renal
artery, renal vein, or ureteral anastomosis

6. Have ongoing treatment for hepatitis C virus (HCV) infection.

7. Have had a recent myocardial infarction (MI) within the past 6 months and/or at the
time of screening are treated with anticoagulants and/or antiplatelet agents
(excluding aspirin) for a previous myocardial infarction.

8. Have a history of: abnormal bleeding, clotting events or disorders (excluding a
history of clotted hemodialysis access or superficial thrombophlebitis in the absence
of medically confirmed coagulopathy), any coagulopathy (documented or clinically
suspected) For example, participants should be excluded if they have a history of
renal allograft arterial or venous thrombosis, deep vein thrombosis, pulmonary
embolism, ischemic cerebrovascular accident (stroke) or transient ischemic attack
(TIA), any large vessel thrombosis.

9. Have a history of allergic reaction to CINRYZE or other blood products.

10. Have had any change in androgen therapy (example, danazol, oxandrolone, stanozolol,
testosterone), tranexamic acid, epsilon-aminocaproic acid, or other fibrinolytics
within 3 months before the first dose of investigational product.

11. Have participated in the active dosing phase of any other investigational drug study
within 30 days prior to dosing with investigational product.

12. Have any of the following local laboratory values reported prior to dosing with
investigational product: Within 24 h prior to participant dosing, white blood cell
(WBC) count <0.5×109/litre (L) or >20×109/L (the value of >20×109/L should be excluded
if obtained during steroid treatment), Within 24 h prior to participant dosing
platelet count <25×109/L or >600×109/L

13. Be pregnant or breastfeeding.

14. Have received any of the following agents within 1 month prior to the first dose of
investigational product: Sucrose-containing intravenous immunoglobulin (IVIg), Any C1
inhibitor (C1 INH) (plasma-derived [example, CINRYZE®, Berinert®, Cetor®] or
recombinant [example, Rhucin®]), Eculizumab (Soliris®), Ecallantide (Kalbitor®).
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Principal Investigator: Nandita Singh, MD
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