Status:
UNKNOWN
Reduction or Discontinuation of CNI's With Conversion to Everolimus-Based Immunosuppresion
Lead Sponsor:
Rabin Medical Center
Collaborating Sponsors:
Novartis
Conditions:
Kidney Diseases
Eligibility:
MALE
Phase:
PHASE4
Brief Summary
This study is design to compare two different strategies aiming to lessen the degree of the ongoing process of allograft injury either by removing tacrolimus from the maintenance immunosuppressive pro...
Detailed Description
This study is design to compare two different strategies aiming to lessen the degree of the ongoing process of allograft injury either by removing tacrolimus from the maintenance immunosuppressive pro...
Eligibility Criteria
Inclusion
- Patients on CNI FK \< 5 ng/m"l with MPA / Imuran with or without steroids
- Renal impairment GFR between 30 - 70 m"l/minute/
- Patient who signed Informed consent
- Patient with no contraindication to renal biopsy
- Women who are not pregnant and will use contraception
Exclusion
- Proteinuria \> 100 m"g/mmol Creatinine
- Acute rejection during 3 months before screening
- WBC \< 2500, plt \< 50,000,
- Nephropathy due to polyoma virus
- Patients on other investigational drugs
- Patients on rapamycin
- Patients with HIV or other systemic infection
- Inability to comply with protocol requirements
- Active or history of malignancy
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
End Date :
February 1 2010
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00443508
Start Date
February 1 2007
End Date
February 1 2010
Last Update
March 6 2007
Active Locations (1)
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1
Transplantation department, rabin Medical Center
Petah Tikva, Israel, 49202