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
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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 July 26, 2014
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs