Status:
UNKNOWN
Efficacy of Certican® in Combination With Myfortic® in Renal
Lead Sponsor:
Hospital Universitário São José
Conditions:
Disorder Related to Renal Transplantation
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief Summary
The primary objective is to demonstrate the superiority of everolimus plus Myfortic® plus corticosteroids following CNI withdrawal at week 16 compared to tacrolimus plus Myfortic® plus corticosteroids...
Detailed Description
1.Forty patients will be selected at 16 weeks of renal transplantation with 20 patients allocated in each study arm. The allocation will be done randomly to provide similar epidemiological characteris...
Eligibility Criteria
Inclusion
- Men and women between 18-70 years old
- Receptors of a first living-donor kidney allograft
- Patients must have been on a tacrolimus+myfortic regimen for at least 2 weeks prior to randomization
Exclusion
- Patients with evidence of any acute rejection following transplantation at the time of randomization
- GFR ≤ 35 ml/min
- Proteinuria \> 800 mg/day
- Recipients of multiple organ transplants
- Chronic hepatic failure
- Asymptomatic bacteriuria
- Creatinine ≥ 2mg/dL on CNI withdrawn time
- Proteinuria ≥ 1g/24h on CNI withdrawn time
- Presence of uncontrolled hypercholesterolemia (≥ 350 mg/dL, ≥ 9.1 mmol/L)
- Hypertriglyceridemia (≥ 500 mg/dL, ≥ 5.6 mmol/L)
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2013
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01399242
Start Date
August 1 2011
End Date
June 1 2013
Last Update
July 21 2011
Active Locations (1)
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1
Hospital Universitário São José
Belo Horizonte, Minas Gerais, Brazil, 30140-073