Status:
COMPLETED
24 Months Follow-up, Two Arm Study to Compare the Cardiovascular Profile in a Regimen With Everolimus + Mycophenolic Acid (MPA) Versus (vs.) a Regimen of CNI+MPA in Maintenance Renal Transplant Recipients
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Renal Transplant
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief Summary
The objective of the study is to compare the cardiovascular profile of an everolimus and mycophenolic acid immunosuppressive regimen with a calcineurin inhibitor and mycophenolic acid regimen in maint...
Eligibility Criteria
Inclusion
- Received kidney transplant \> 6 months and \< 3 years prior to study enrollment
- Receiving immunosuppressive regimen that includes tacrolimus and mycophenolic acid
- Between 18 and 70 years of age
- Willing to provide written informed consent
Exclusion
- Patients with an actual serum creatinine ≥ 2 mg/dl and/or eGFR≤ 40 ml/min and/or proteinuria≥ 500mg/day
- Patients who suffered from severe humoral and/or cellular rejection (≥ BANFF IIb, recurrent acute rejection or steroid resistant acute rejection in the previous years
- 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.
- Diabetic patients
- Woman of child-bearing potential who is planning to become pregnant or is pregnant and/or lactating who is unwilling to use effective means of contraception
- Presence of psychiatric illness (i.e., schizophrenia, major depression) that, in the opinion of the site investigator, would interfere with study requirements
- Any other medical condition that, in the opinion of the site investigator based on recall or chart review would interfere with completing the study
- Receiving any investigational drug or have received any investigational drug within 30 days prior to study enrollment
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
71 Patients enrolled
Trial Details
Trial ID
NCT01169701
Start Date
August 1 2010
End Date
March 1 2014
Last Update
December 7 2015
Active Locations (9)
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1
Novartis Investigative Site
Málaga, Andalusia, Spain, 29010
2
Novartis Investigative Site
L'Hospitalet de Llobregat, Barcelona, Spain, 08907
3
Novartis Investigative Site
Barcelona, Catalonia, Spain, 08003
4
Novartis Investigative Site
Barcelona, Catalonia, Spain, 08025