Open Label controlled trial of eculizumab in the prevention of AMR in living donor kidney transplant recipients requiring desensitization.

Active, not recruiting

• Conditions: Antibody mediated rejection after kidney transplant; MedDRA version: 14.1Level: SOCClassification code 10021428Term: Immune system disordersSystem Organ Class: 10021428 - Immune system disorders; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2010-019630-28-IT
• Lead Sponsor: ALEXION PHARMACEUTICALS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-08
• Last Update Posted: 11 April 2016

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1. Male or female patients =18 years old 2. Patients with Stage IV or Stage V chronic kidney disease who will receive a kidney transplant from a living donor to whom they are sensitized and require desensitization prior to transplantation 3. History of prior exposure to HLA: a. Prior solid organ or tissue allograft b. Pregnancy c. Blood transfusion d. Prior exposure to specific donor’s HLA 4. The presence of DSA by the SAB assay (Luminex LabScreen assay), as described by the manufacturer’s package insert 5. Positive CDC cross match (current or historic) and BFXM and TFXM < 450mcs OR have a negative CDC cross match AND a BFXM or TFXM > 300 and < 450mcs. No patient may have a BFXM or TFXM > 450mcs. 6. Able to understand the informed consent form and willing to comply with study procedures 7. Female patients of child-bearing potential must have a negative pregnancy test (serum beta-hCG) and must be practicing an effective, reliable and medically approved contraceptive regimen while on eculizumab treatment and for up to 5 months following discontinuation of treatment.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Has received treatment with eculizumab at any time prior to enrolling in this study 2. ABO incompatible with living donor 3. 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) 4. Prior splenectomy 5. Has a known bleeding disorder 6. Has any active bacterial or other infection which is clinically significant in the opinion of the Investigator and is a contraindication to transplantation 7. Has participated in any other investigational drug study or was exposed to an investigational drug or device within 30 days of screening 8. Has received rituximab (Rituxan) = 3 months prior to screening 9. Has received bortezomib (Velcade) = 3 months prior to screening 10. Has received alemtuzumab (Campath) = 6 months prior to screening 11. Hypersensitivity to eculizumab, to murine proteins or to one of the excipients 12. History of illicit drug use or alcohol abuse within the previous year 13. Unresolved meningococcal disease 14. Current cancer or a history of cancer within the 5 years prior to screening with the exception of patients who have successfully treated nonmetastatic basal or squamous cell carcinoma of the skin; carcinoma in situ of the cervix; or breast carcinoma in situ 15. 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 16. Active infection with Hepatitis B (HBV), Hepatitis C (HCV) or human immunodeficiency virus (HIV)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the safety and efficacy of eculizumab to prevent AMR in sensitized recipients of living donor kidney transplants requiring desensitization therapy.;Secondary Objective: Safety and efficacy;Primary end point(s): To evaluate the safety and efficacy of eculizumab to prevent AMR in sensitized recipients of living donor kidney transplants requiring desensitization therapy;Timepoint(s) of evaluation of this end point: 9 weeks

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Cumulative incidence of AMR that occur between week 9and month 12;Timepoint(s) of evaluation of this end point: 1 year