Efficacy and Safety of Eculizumab for Treatment of Antibody-mediated Rejection Following Renal Transplantation
NCT ID: NCT01895127
Last Updated: 2017-09-21
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
11 participants
INTERVENTIONAL
2013-11-30
2016-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Standard of Care
* Plasmapheresis (PP) x 3, at 40-60 cc/kg.
* Immunoglobulin (IVIg), to be administered after each PP
Immunoglobulin
Plasmapheresis
Soliris (eculizumab)
* 1200 mg first dose (Time: Screening/Week "0", after Biopsy Proven AMR)
* 900 mg weekly for 4 doses (Weeks 1, 2, 3, 4)
* 1200 mg week 5
* Week 6: If donor specific antibody \< 50% of baseline DSA then no further treatment, otherwise 1200 mg weeks 7, 9
Eculizumab
Interventions
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Eculizumab
Immunoglobulin
Plasmapheresis
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Any patient with acute graft dysfunction (elevation of creatinine above post transplant nadir)
3. Presence of circulating anti human leukocyte antigen (HLA) antibody (DSA "donor specific antibody").
4. Histological findings compatible with Banff Class II or III AMR on transplant biopsy.
5. Peritubular capillary c4d positivity on transplant biopsy.
Exclusion Criteria
2. Patients with ongoing non-acute antibody mediated rejection.
3. Patients with predominantly chronic antibody mediated rejection or interstitial fibrosis/tubular atrophy.
4. History of severe cardiac disease (e.g., New York Heart Association \[NYHA\] Functional Class III or IV, myocardial infarction ≤ 6 months of randomization, ventricular tachyarrhythmias requiring ongoing treatment, unstable angina or other significant cardiovascular diseases)
5. Prior splenectomy
6. Has a known bleeding disorder
7. Has any active bacterial or other infection which is clinically significant in the opinion of the Investigator and is a contraindication to transplantation
8. Has participated in any other investigational drug study or was exposed to an investigational drug or device within 30 days of screening
9. Has received rituximab (Rituxan®) ≤ 3 months prior to screening
10. Has received bortezomib (Velcade®) ≤ 3 months prior to screening
11. Has received alemtuzumab (Campath®) ≤ 6 months prior to screening
12. Need for concurrent treatment with anti thymocyte globulin (Thymoglobulin®)
13. Hypersensitivity to murine proteins or to one of the product excipients
14. History of illicit drug use or alcohol abuse within the previous year
15. Unresolved meningococcal disease
16. Pregnancy or lactation
17. Current cancer or a history of cancer within the 5 years prior to screening with the exception of patients who have successfully treated non-metastatic basal or squamous cell carcinoma of the skin; carcinoma in situ of the cervix; or breast carcinoma in situ
18. Any medical condition that, in the opinion of the Investigator, might interfere with the patient's participation in the study, poses an added risk for the patient, or confounds the assessment of the patient Active infection with Hepatitis B (HBV), Hepatitis C (HCV) or human immunodeficiency virus (HIV)
18 Years
75 Years
ALL
No
Sponsors
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Alexion Pharmaceuticals, Inc.
INDUSTRY
Brigham and Women's Hospital
OTHER
Responsible Party
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Anil K. Chandraker, MD
Medical Director of Kidney and Pancreas Transplantation
Principal Investigators
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Anil K Chandraker, MD
Role: PRINCIPAL_INVESTIGATOR
Brigham and Women's Hospital
Locations
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UCSF Medical Center
San Francisco, California, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
University of Michigan Medical Center
Ann Arbor, Michigan, United States
Countries
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Other Identifiers
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2013P001292
Identifier Type: -
Identifier Source: org_study_id