Study Investigating a Standard Regimen in de Novo Kidney Transplant Patients Versus a Calcineurin Inhibitor (CNI)-Free Regimen and a CNI-low Dose Regimen
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
First received: August 9, 2007
Last updated: March 4, 2014
Last verified: March 2014
The purpose of this study is to compare renal function of immunosuppressive regimens with different relevance of the calcineurin inhibitor (CNI) cyclosporine: standard dose CNI, low dose CNI, CNI free in de novo kidney transplant patients after 12 months of therapy.
Drug: Myfortic and Neoral
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
||Multi-center, Open-label, Prospective, Randomized, Parallel Group, Long-term Study Investigating a Standard Regimen in de Novo Kidney Transplant Patients Versus a CNI-free Regimen and a CNI-low Dose Regimen
Primary Outcome Measures:
- Renal function assessed by glomerular filtration rate (GFR) - Nankivell method - 12 months after renal transplantation (Tx)
Secondary Outcome Measures:
- Renal function glomerular filtration rate M12 post by serum creat.at M12 post Tx Efficacy(biopsy proven acute ejection,graft loss,death) at M6&M12 Occurrence treatment failures up to or at M12, Evolution of renal function between M3&M12 creatinine slope
| Estimated Enrollment:
| Study Start Date:
| Estimated Primary Completion Date:
||August 2015 (Final data collection date for primary outcome measure)
Other Name: certican
Active Comparator: 2
Drug: Myfortic and Neoral
Other Name: myfortic and neoral
|Ages Eligible for Study:
||18 Years to 70 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Males or females, aged 18 - 70 years
- Recipients of de novo cadaveric, living unrelated or living related kidney transplants
- Females capable of becoming pregnant must have a negative serum pregnancy test within 7 days prior to or at screening, and are required to practice an approved method of birth control for the duration of the study and for a period of 6 weeks following discontinuation of study medication, even where there has been a history of infertility.
- Patients who are willing and able to participate in the study and from whom written informed consent has been obtained.
- More than one previous renal transplantation
- Multi-organ recipients (e.g., kidney and pancreas) or previous transplant with any other organ, different from kidney
- Patients receiving a kidney from a non-heart beating donor
- Donor age: < 5 years or > 70 years
- Graft loss due to immunological reasons in the first year after transplantation (in case of secondary transplantation)
- Other protocol-defined inclusion/exclusion criteria may apply
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00514514
|Berlin, Germany, 10117 |
No publications provided
||Novartis ( Novartis Pharmaceuticals )
History of Changes
|Other Study ID Numbers:
|Study First Received:
||August 9, 2007
||March 4, 2014
||Germany: Federal Institute for Drugs and Medical Devices
Keywords provided by Novartis:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on August 28, 2014
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs