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.
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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 August 28, 2014
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs