ATHENACertican-Based Immunosuppressive Regimens vs. Standard Treatment in de Novo Kidney Transplant Recipients
This study aims to demonstrate that a Certican-based immunosuppressive regimen is as effective as the standard treatment in maintaining kidney function, measured by Glomerular Filtration Rate, in new kidney transplant recipients after 12 months.
Tacrolimus Capsules for Transplant
+ Enteric Coated Mycophenolate Sodium (EC-MPS) Study
+ Mycophenolate Mofetil (MMF) Capsules
Behavior+2
+ Immune System Diseases
+ Social Behavior
Treatment Study
Summary
Study start date: December 27, 2012
Actual date on which the first participant was enrolled.This study focuses on kidney transplant patients, specifically those who are new to kidney transplantation. The main goal is to compare the effectiveness of a standard treatment using Mycophenolic Acid and Tacrolimus with two different treatments using Certican® in combination with either Cyclosporin A or Tacrolimus. The study aims to find out if these Certican® based treatments can provide similar or better kidney function than the standard treatment. This research is important as it could potentially improve the care and treatment options for individuals who have undergone a kidney transplant. During this 12-month study, participants are randomly assigned to one of the three treatment groups. The study measures the renal function of each participant using a specific formula called the Nankivell method. This formula considers factors like body weight, serum creatinine concentration, serum urea, and height to calculate the glomerular filtration rate (GFR), which is an indicator of kidney function. The primary goal is to show that at least one of the Certican® treatment regimens is not inferior to the standard regimen in terms of kidney function at the end of the 12-month period.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.612 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: Patient who had received a primary or secondary kidney transplant Patients who were willing and from whom written informed consent was obtained kidney allograft with a cold ischemia time (CIT) < 30 hours negative pregnancy test prior to study enrollment Exclusion Criteria: --Multi-organ recipients former Graft loss due to immunological reasons Patients who received a kidney from a non-heart beating donor A-B-0 incompatible transplants a current Panel Reactive Antibody (PRA) level of > 20% existing antibodies against the HLA-type of the receiving transplant a known hypersensitivity/contraindication to any of the immunosuppressants Use of other investigational drugs Patients with thrombocytopenia (platelets < 100,000/mm³), with an absolute neutrophil count of < 2,000/mm³ or leucopenia (leucocytes < 3,000/mm³), or hemoglobin < 8 g/dL significant mental illness history of malignancy during the last five years HIV positive uncontrolled hypercholesterolemia or hypertriglyceridemia drug or alcohol abuse pregnant or breast feeding women
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.3 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Active ComparatorGroup II
ExperimentalGroup III
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 27 locations
Novartis Investigative Site
Bordeaux, FranceNovartis Investigative Site
Brest, FranceNovartis Investigative Site
Créteil, France