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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 ) Identifier:
First received: April 19, 2007
Last updated: November 15, 2016
Last verified: November 2016
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 Intervention Phase
De Novo Renal Transplantation Drug: everolimus Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

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: 20
Study Start Date: September 2006
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.

  Contacts and Locations
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Please refer to this study by its identifier: NCT00464399

Novartis Investigative Site,
Oslo, Norway
Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Novartis
  More Information

Responsible Party: Novartis Pharmaceuticals Identifier: NCT00464399     History of Changes
Other Study ID Numbers: CRAD001ANO01
Study First Received: April 19, 2007
Last Updated: November 15, 2016

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
De novo renal transplantation
CNI-free protocol

Additional relevant MeSH terms:
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Dermatologic Agents
Antirheumatic Agents
Calcineurin Inhibitors processed this record on August 18, 2017