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®).
We found this trial at
30
sites
630 W 168th St
New York, New York
212-305-2862
Principal Investigator: Lloyd Ratner
Phone: 212-342-3539
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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3400 N Charles St
Baltimore, Maryland 21205
410-516-8000
Principal Investigator: Sami Alasfar, MD
Phone: 410-382-6853
Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Principal Investigator: Anil Chandraker, MD
Phone: 617-732-7412
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Principal Investigator: Richard Fatica
Phone: 216-312-3050
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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1500 Northwest 12th Avenue # 106
Miami, Florida 33136
Principal Investigator: Adela Mattiazzi, MD
Phone: 305-355-5241
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Minneapolis, Minnesota 55455
(612) 625-5000
Principal Investigator: Ty Dunn
Phone: 612-625-4758
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Principal Investigator: Heidi Schaefer
Phone: 615-936-0700
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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1968 Peachtree Rd NW
Atlanta, Georgia 30309
(404) 605-5000
Principal Investigator: Joshua Wolf
Phone: 404-605-2629
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Aurora, Colorado 80045
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22 S Greene St
Baltimore, Maryland 21201
(410) 328-8667
Principal Investigator: Abdolreza Haririan
Phone: 410-328-3720
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251 E Huron St
Chicago, Illinois 60611
(312) 926-2000
Principal Investigator: John Friedewald
Phone: 312-695-0338
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2600 Clifton Ave
Cincinnati, Ohio 45267
(513) 556-6000
Principal Investigator: Ervin Woodle
Phone: 513-584-0985
University of Cincinnati The University of Cincinnati offers students a balance of educational excellence and...
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Columbus, Ohio 43210
Principal Investigator: Ronald Pelletier
Phone: 614-293-4627
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Fort Worth, Texas 76104
Principal Investigator: Bernard Fischbach
Phone: 817-922-7667
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6550 Fannin St
Houston, Texas 77030
(713) 790-3311
Principal Investigator: Ahmed Gaber
Phone: 713-441-6170
Houston Methodist Hospital Houston Methodist is comprised of a leading academic medical center in the...
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94 Old Short Hills Road
Livingston, New Jersey 07039
(973) 322-5000
Principal Investigator: Anup Patel
Phone: 973-322-8216
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Los Angeles, California 90095
Principal Investigator: Suphamai Bunnapradist, MD
Phone: 310-794-8516
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Los Angeles, California 90008
Principal Investigator: Yasir Qazi, MD
Phone: 323-442-5908
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Monroeville, Pennsylvania 15146
Principal Investigator: Puneet Sood
Phone: 412-648-6048
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New York, New York 10029
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New York, New York 10021
Principal Investigator: Jim Kim
Phone: 212-746-5330
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Oklahoma City, Oklahoma 73112
Principal Investigator: Jose El-Amm
Phone: 405-949-3349
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Orlando, Florida 32804
Principal Investigator: Bobby Nibhanupudy, MD
Phone: 407-303-2474
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Philadelphia, Pennsylvania 19104
Principal Investigator: Roy Bloom, MD
Phone: 215-662-4643
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Principal Investigator: Daniel Brennan
Phone: 314-362-8351
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Salt Lake City, Utah 84132
Principal Investigator: Fuad Shihab, MD
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San Francisco, California 94143
Principal Investigator: Allison Webber, MD
Phone: 415-353-1290
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1081 Burrard Street
Vancouver, British Columbia V6Z 1Y6
Principal Investigator: John Gill, MD
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Washington, District of Columbia 20007
Principal Investigator: Alexander Gilbert
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311 North Street
White Plains, New York 10605
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