Status:
COMPLETED
Role of Everolimus in Highly Sensitized Patients
Lead Sponsor:
Joseph Kahwaji, MD, MPH
Collaborating Sponsors:
Novartis
Conditions:
Highly-sensitized Kidney Transplant Recipients
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
A growing number of patients on the kidney transplant waiting list are broadly human leukocyte antigen (HLA) sensitized (HS). These patients are unlikely to have a compatible donor. Therefore they wai...
Eligibility Criteria
Inclusion
- Recipient of a deceased or living donor kidney allograft
- Patients must have undergone desensitization with IVIG and rituximab with or without plasma exchange prior to transplant or be administered IVIG and rituximab peri-operatively.
- Age 18 and over
- Able to understand and provide informed consent
Exclusion
- Recipients of a dual simultaneous kidney/liver, kidney/heart, kidney/lung transplant 2. Pregnant or lactating females 3. Patients with a platelet count \< 100,000/mm3 at time of randomization 4. Patients with an absolute neutrophil count \< 1,500/mm3 or a white blood cell count of \<3,000/mm3 at time of randomization 5. Patients who have an abnormal liver profile such as ALT, AST, Alkaline Phosphatase, or total bilirubin \> 3 times the upper limit of normal (ULN) at time of randomization 6. Patients with severe total hypercholesterolemia (\> 350 mg/dL; \> 9 mmol/L) or total hypertriglyceridemia (\> 500 mg/dL; \> 5.6 mmol/L). Patients on lipid lowering treatment with controlled hyperlipidemia are acceptable.
- 7\. History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes 8. Patients being treated with drugs that are strong inducers or inhibitors of cytochrome P450 3A4 9. Patients with a clinically significant systemic infection within 30 days prior to transplant 9 10. Patients who have any surgical or medical condition, such as severe diarrhea, active peptic ulcer disease, or uncontrolled diabetes mellitus, which in the opinion of the investigator, might significantly alter the absorption, distribution, metabolism and/or excretion of study medication.
- 11\. Patients with a history of coagulopathy or medical condition that would require long-term anticoagulation therapy after transplantation, unless the condition would permit a two week interruption in therapy before and after allograft biopsy. (Treatment with low dose aspirin is allowed.) 12. Women of childbearing potential who are either pregnant, lactating, planning to become pregnant during this trial, or with a positive serum or urine pregnancy test. Women of childbearing potential must be willing to agree to contraceptive practices.
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 19 2016
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01911546
Start Date
June 1 2013
End Date
January 19 2016
Last Update
December 7 2017
Active Locations (1)
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1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048