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Feasibility and Safety of Early Switch to Everolimus From Cyclosporine in de Novo Renal Transplant Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00464399
Recruitment Status : Completed
First Posted : April 23, 2007
Last Update Posted : November 16, 2016
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
De Novo Renal Transplantation Drug: everolimus Phase 3

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Study Type : Interventional  (Clinical Trial)
Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study to Evaluate Feasibility and Safety of Early Switch to Everolimus From Cyclosporine in de Novo Renal Transplant
Study Start Date : September 2006
Actual Primary Completion Date : December 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Everolimus

Primary Outcome Measures :
  1. 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 :
  1. 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
  2. Pharmacokinetics assessed by blood samples for everolimus concentration , cyclosporine concentrations
  3. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00464399

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Novartis Investigative Site,
Oslo, Norway
Sponsors and Collaborators
Novartis Pharmaceuticals
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Study Director: Novartis Novartis
Publications of Results:
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Responsible Party: Novartis Pharmaceuticals Identifier: NCT00464399    
Other Study ID Numbers: CRAD001ANO01
First Posted: April 23, 2007    Key Record Dates
Last Update Posted: November 16, 2016
Last Verified: November 2016
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
De novo renal transplantation
CNI-free protocol
Additional relevant MeSH terms:
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Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs