Status:
COMPLETED
Concentration Controlled Everolimus With Reduced Dose Cyclosporine Versus Mycophenolate Mofetil With Standard Dose Cyclosporine in de Novo Renal Transplant Adult Recipients Treated With Basiliximab and Corticosteroids
Lead Sponsor:
Novartis
Conditions:
Kidney Transplantation
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
The 12 Month Core Study (CRAD001A1202) was designed to evaluate the efficacy and safety comparing concentration-controlled everolimus (1.5 mg/day starting dose) with reduced dose cyclosporine and cort...
Eligibility Criteria
Inclusion
- Core Study
- Male or female de novo renal transplant recipients between 18 and 65 years of age
- Patients who are receiving a primary cadaveric donor or non-human leukocyte antigen (non-HLA) identical living donor kidney transplant
- Patients who have given written informed consent to participate in the study
- Females capable of becoming pregnant must have a negative pregnancy test prior to randomization.
- Core Study
Exclusion
- Patients with no evidence of graft function within 24 hours of transplantation are excluded
- Recipients of dual kidney transplants
- Patients who are recipients of multiple solid organ or tissue transplants, or have previously received an organ or tissue transplant.
- Recipients of kidneys from HLA-identical living related donors
- Patients who are recipients of ABO incompatible transplants or T cell cross match positive transplant. Although Panel Reactive Antibodies (PRA) test is not mandatory, patients whose most recent anti-HLA Class I PRA \>20% By a CDC-(Complement dependent cytotoxicity) based assay or \>50% by a Flow Cytometry or ELISA (Enzyme linked immunosorbent assay) -based assay
- Patients who have tested positive for human immunodeficiency virus (HIV), hepatitis C virus (HCV), or Hepatitis B surface antigen. Laboratory results obtained within 6 months prior to randomization are acceptable, otherwise these tests should be performed within two weeks prior to randomization.
- Recipients of organs from donors who test positive for Hepatitis B surface antigen, HCV or HIV are excluded
- Donor organ with a cold ischemia time \>24 hours
- Donor age greater than 65 years
- Patients with platelet count \<100,000/mm at baseline before transplantation
- Patients with an absolute neutrophil count of \< 1,500/mm³ or white blood cell count of \< 4,500/mm³ at baseline before transplantation
- Patients who have severe hypercholesterolemia (\>350 mg/dL; \>9 mmol/L) or hypertriglyceridemia (\>500 mg/dL; \>8.5 mmol/L). Patients with controlled hyperlipidemia are acceptable
- Patients who have an abnormal liver profile such as alanine aminotransferase (ALT), Aspartate aminotransferase (AST), alkaline phosphatase (ALP) or total bilirubin \>3 times the upper limit of normal (ULN)
- Patients with a known hypersensitivity to either of the study drugs or their class, or to any of the excipients
- Patients who are treated with drugs that are strong inducers or inhibitors of cytochrome P450
- Patients who are unable to take oral medication at time of randomization
- Patients who received an investigational drug or who have been treated with a non-protocol immunosuppressive drug or treatment within 30 days or 5 half-lives prior to randomization
- Patients with a history of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized excised non-melanomatous skin lesions
- Patients with clinically significant systemic infection at time of transplant or within two weeks prior to transplant
- Patients with a history of severe diarrhea, active peptic ulcer disease, or uncontrolled diabetes mellitus
- Patients who have cardiac failure at time of screening (resting dyspnea, with Grade ≥ 3 according to Old New York Heart Association Classification (Appendix 7) or any severe cardiac disease as determined by the investigator
- Patients who have any surgical or medical condition, which in the opinion of the investigator, might significantly alter the absorption, distribution, metabolism and excretion of study medication
- Patients with abnormal physical or laboratory findings of clinical significance within 2 weeks prior to randomization which would interfere with the objectives of the study
- Patients with any history of coagulopathy or medical condition requiring long-term anticoagulation which would preclude renal biopsy after transplantation. (Low dose aspirin treatment or interruption of chronic anticoagulant is allowed)
- Females of childbearing potential who are planning to become pregnant, who are pregnant and/or lactating, who are unwilling to use effective means of contraception.
- Extension Study Inclusion Criteria:
- Patients who completed Month 12 visit in core study (including patients who had discontinued study medication)
- Patients who had given written informed consent to participate in this extension study
- Extension Study
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
122 Patients enrolled
Trial Details
Trial ID
NCT00658320
Start Date
February 1 2008
End Date
May 1 2012
Last Update
June 21 2013
Active Locations (1)
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1
Novartis Pharma K.K., Japan
Tokyo, Japan, 106-8618