Feasibility and Safety of Early Switch to Everolimus From Cyclosporine in de Novo Renal Transplant Patients
This study has been completed.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
First received: April 19, 2007
Last updated: March 6, 2014
Last verified: March 2014
To evaluate the safety and tolerability of early switch to everolimus from cyclosporine A in de novo renal transplant recipients by assessing rejection rate everolimus trough levels, other safety laboratory variables and adverse events.
De Novo Renal Transplantation
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||A Pilot Study to Evaluate Feasibility and Safety of Early Switch to Everolimus From Cyclosporine in de Novo Renal Transplant
Primary Outcome Measures:
- Biopsy proven acute rejections or treatment for acute rejections from the time of the conversion from cyclosporine based regimen to a cyclosporine free treatment with everolimus 7 weeks ± 7 days after transplantation until completion of 7 weeks after
Secondary Outcome Measures:
- Efficacy assessed by graft and patients survival from the time of conversion 7 weeks ± 7 days until the end of follow-up 12 months after transplantation
- Pharmacokinetics assessed by blood samples for everolimus concentration , cyclosporine concentrations
- Safety assessed by blood sampling for Hemoglobin, white blood cells (WBC), platelets, s-creatinine, ASAT, ALAT, ALP bilirubin, S-Na, S-K, S-Ca, S-P. S-Urea, S-creatin phosphokinase (S-CPK), u-alb/creatinine ratio
| Estimated Enrollment:
| Study Start Date:
| Primary Completion Date:
||December 2012 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
- Male or female aged above 18 years.
- Patients having received their first or second single renal transplant from deceased or living donor
- Patient willing and capable of giving written informed consent for study participation
- Patients treated with as induction therapy at the time of transplantation
- Patients maintained on a triple immunosuppressive regime consisting of cyclosporine (C-0 h between 100-250 ng/ml or a C-2 h between 900-1100 ng/ml), Enteric coated mycophenolate sodium (EC-MPS), minimum dose 1080 mg and corticosteroids, minimum dose 10 mg
- Patients without any biopsy proven acute rejection episode or treatment for any acute rejection since the transplant
- Females capable of becoming pregnant must have a negative pregnancy test prior to the switch to everolimus and are required to practice a medically approved method of birth control for the duration of the study and a period of 8 weeks following discontinuation of study medication, even where there has been a history of infertility.
- Recipient of multi-organ transplants, and or previously transplanted with any other organ different from a kidney transplant
- Patients with antibodies towards the donor kidney above 30%
- Patients receiving a renal transplant from HLA-identical sibling
- Presence of hyper sensitivity to drugs similar to everolimus ( e.g. macrolides)
- Patient with past (within the last two years) or present malignancy other than excised basal cell or squamous cell carcinoma of the skin
- Patients who are recipients of AB0 incompatible transplants
- Patients with unsuitable laboratory values
- Patients with ongoing wound healing problems or other severe surgical complication in the opinion of the investigator
- Patient with a current severe major local or systemic infection
- Patients requiring dialysis and/or having a calculated glomerular filtration rate (Cockcroft-Gault) < 20 ml/min
- Presence of intractable immunosuppressant complications or side effects (e.g., severe gastrointestinal adverse events) at the time of the switch
- Patients who are HIV positive or Hepatitis B surface antigen positive or Hepatitis C virus positive. Recipients of organs from donors who test positive for Hepatitis B surface antigen or Hepatitis C are excluded.
- Evidence of severe liver disease
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: NCT00464399
|Novartis Investigative Site,
|Oslo, Norway |
No publications provided
||Novartis ( Novartis Pharmaceuticals )
History of Changes
|Other Study ID Numbers:
|Study First Received:
||April 19, 2007
||March 6, 2014
||Norway: Statens Legemiddelverk (SLV)
Keywords provided by Novartis:
De novo renal transplantation
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 16, 2014
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action