Clinical Trials Directory

Trials / Unknown

UnknownNCT01595984

Comparison of Efficacy and Safety of Treatment With a Calcineurin Inhibitor (CNI)Versus a CNI-free Treatment in Renal Transplantation (CIME)

Randomized, Multicenter, Open-label, Comparative Study of Efficacy and Safety of Treatment With a Calcineurin Inhibitor (CNI), Associating Myfortic ® and Neoral ® Compared to a CNI-free Treatment, Combining Myfortic ® and Certican ® , in Adult Patients With de Novo Renal Transplant

Status
Unknown
Phase
Phase 3
Study type
Interventional
Enrollment
90 (actual)
Sponsor
Centre Hospitalier Universitaire, Amiens · Academic / Other
Sex
All
Age
18 Years – 70 Years
Healthy volunteers
Not accepted

Summary

The main objective of this protocol is to compare the impact on renal function of two different immunosuppressive regimens in patients with de novo renal transplant. Renal function will be accurately evaluated by measuring the clearance of iohexol. The protocol will also evaluate the efficacy and safety in a short term of these two different immunosuppressive regimens.

Conditions

Interventions

TypeNameDescription
DRUGcyclosporin + mycophenolate mofetilantirejection drug, renal transplantation
DRUGeverolimus + mycophenolate mofetilantirejection drug, renal transplantation

Timeline

Start date
2012-05-03
Primary completion
2018-08-01
Completion
2018-08-01
First posted
2012-05-10
Last updated
2018-08-21

Locations

2 sites across 1 country: France

Source: ClinicalTrials.gov record NCT01595984. Inclusion in this directory is not an endorsement.